- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04751773
Postoperative Exercise Training in Patients With Colorectal Liver Metastases Undergoing Surgery (ELMA) (ELMA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND:
Colorectal cancer is the third most frequent type of cancer in Denmark, with more than 5000 new cases annually. Colorectal liver metastases (CRLM) develop in nearly one fourth of all patients with colorectal cancer, and poses a poor prognostic outlook, with low survival rates and short time to disease progression. Surgical resection, either upfront or following downstaging with perioperative treatments, confers substantial survival benefit in patients with CRLM, and may even comprise a curative treatment modality. However, surgery elicits a cascade of biological responses characterized by increased dissemination of tumor cells and modulation of neuroendocrine, inflammatory, and immunological factors. These local and systemic perturbations typically persist for days to weeks following surgery and may independently or in concert drive the onset of long-term disease progression. Under normal physiological conditions, exercise training is a potent modulator of immune function, systemic inflammation, and the neuroendocrine system, raising the possibility that perioperative exercise training may ameliorate the surgical stress response during and after surgery. However, in a recent systematic review and meta-analysis (submitted), we found that the effects and safety of preoperative and early postoperative exercise are unknown in patients with gastrointestinal cancers (including CRLM) due to lack of studies, widespread methodological issues, and poor ascertainment and reporting of adverse events. Safety is arguably the single most important consideration for the application perioperative exercise, and methodological robust trials evaluating the safety and tolerability of perioperative exercise training along with preliminary information on treatment efficacy are needed to inform the application of exercise in surgical oncology.
Against this background, we designed the present randomized controlled trial to evaluate the therapeutic role of postoperative exercise training in patients with CRLM undergoing open liver resection. The primary trial objective and hypothesis are:
To compare the number of serious adverse events (SAE) in standard care plus postoperative exercise (EX) vs. standard care alone (CON) in patients with colorectal liver metastases scheduled to undergo open liver resection. The primary research hypothesis is that the number of SAEs is non-inferior in EX vs. CON
The key secondary study objectives and hypotheses are:
- To compare the effect of EX vs. CON on incidence of postoperative hospital admissions in patients with CRLM undergoing surgery. We hypothesize that the incidence of postoperative hospital admissions are non-inferior in EX vs. CON
- To compare the effect of EX vs. CON on relative dose intensity of adjuvant chemotherapy and time from surgery to initiation of adjuvant chemotherapy in patients with CRLM undergoing surgery. We hypothesize that the relative dose intensity of adjuvant chemotherapy and time from surgery to initiation of adjuvant chemotherapy are non-inferior in EX vs. CON.
- To compare the effect of EX vs. CON on selected patient-reported symptomatic adverse events in patients with CRLM undergoing surgery
To compare the effect of EX vs. CON on surgical stress responses (neuroendocrine, inflammatory, and immune factors) in patients with CRLM undergoing surgery.
The secondary study objectives are:
- To evaluate the feasibility of EX.
- To compare the effect of EX vs. CON on functional capacity, muscle strength, aerobic capacity, and body composition in patients with CRLM undergoing surgery.
- To compare the effect of EX vs. CON on clinical outcomes in patients with CRLM undergoing surgery.
- To compare the effect of EX vs. CON on patient-reported outcomes in patients with CRLM undergoing surgery.
- To compare the effect of EX vs. CON on circulating tumor DNA and DNA methylation in patients with CRLM undergoing surgery
- To evaluate the effects of acute pre- and postoperative exercise on neuroendocrine, immunological, and inflammatory factors in patients with CRLM undergoing surgery.
- To conduct explorative preclinical sub-studies.
TRIAL DESIGN:
This trial is a single-center, randomized, controlled, parallel-group trial performed at Centre for physical Activity (CFAS), Rigshospitalet, Copenhagen, Denmark, and Department of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.
A total of 60 participants with CRLM will be included and randomly allocated 2:1 to standard care and postoperative exercise training (EX) or standard care alone (CON). The participants will undergo two trial visits at CFAS during the study period: One preoperative trial visit (1-3 days after inclusion and 2-7 days before surgery) and one post-surgery trial visit (8 weeks after discharge). For each visit, the participants will be assessed for body composition and anthropometrics, resting cardiovascular factors, standard blood biochemistry, aerobic capacity (VO2peak, ventilatory threshold), maximal muscle strength, and functional performance. In addition, blood samples will be taken before, during, and immediately after surgery, and on post-operative day 1, 3, and 15 and neuroendocrine, inflammatory, and immune factor will be analyzed. Patient-reported outcomes will be collected at all trial visits and 1, 2, and 3 years after randomization. Data from medical records regarding mortality and disease recurrence will be collected up to 3 years after randomization. As an optional procedure, we will collect blood samples before, during, and after a pre- and a postoperative supervised exercise training session.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Simon N Thomsen, MSc
- Phone Number: +45-3545-6550
- Email: simon.noerskov.thomsen@regionh.dk
Study Locations
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Copenhagen, Denmark
- Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria: Participants diagnosed with colorectal liver metastasis planned for open surgery of liver metastases
Exclusion Criteria:
- Age <18
- Pregnancy
- Other known malignancy requiring active cancer treatment that prohibits execution of test or training procedures
- Conditions that prohibit execution of trial procedures
- Inability to understand the Danish language.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Standard care alone (CON)
Participants allocated to CON receive the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark. Participants allocated to CON are allowed to exercise on their own initiative or participate in any standard care hospital- or municipality-based exercise training program. |
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Experimental: Postoperative exercise training and standard care (EX)
Participants allocated to EX receive the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark, and postoperative exercise training. The postoperative exercise training program consists of 8 weeks of supervised and home-based exercise 5 times/week. The intensity and duration are progressively increased during the postoperative period |
Perioperative exercise training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Serious adverse events
Time Frame: From discharge to 8 weeks after discharge
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From discharge to 8 weeks after discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative hospital admissions
Time Frame: From discharge to 8 weeks after discharge
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Incidence of postoperative hospital re-admissions, defined as any non-scheduled ≥ 24 h hospitalization
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From discharge to 8 weeks after discharge
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Relative dose intensity (RDI) of adjuvant chemotherapy
Time Frame: From date of planned initiation of adjuvant chemotherapy until 8 weeks after discharge
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RDI (%) of adjuvant chemotherapy, calculated as the actual dose intensity / standard dose intensity x 100%
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From date of planned initiation of adjuvant chemotherapy until 8 weeks after discharge
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Time to initiation of adjuvant chemotherapy
Time Frame: From surgery until 8 weeks after discharge
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Time from surgery to initiation of adjuvant chemotherapy
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From surgery until 8 weeks after discharge
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Patient-reported symptomatic adverse events
Time Frame: Baseline, 7 days after discharge, 7 days after each administration of adjuvant chemotherapy, 8 weeks after discharge.
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Patient-reported symptomatic adverse events, assessed using the using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
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Baseline, 7 days after discharge, 7 days after each administration of adjuvant chemotherapy, 8 weeks after discharge.
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Surgical stress: IL-1β
Time Frame: Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in blood IL-1β concentration
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Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Surgical stress: IL-6
Time Frame: Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in blood IL-6 concentration
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Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Surgical stress: IL-8
Time Frame: Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in blood IL-8 concentration
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Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Surgical stress: IL-10
Time Frame: Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in blood IL-10 concentration
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Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Surgical stress: interferon- γ
Time Frame: Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in blood interferon- γ concentration
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Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Surgical stress: C-reactive protein
Time Frame: Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in blood C-reactive protein
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Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Surgical stress: Leukocyte differential counts
Time Frame: Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in blood leukocyte cell counts (total and per type [eosinophils, basophils, lymphocytes, monocytes, neutrophils])
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Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Surgical stress: Natural killer (NK) cells
Time Frame: Baseline, after resection, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in blood NK cell count
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Baseline, after resection, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Surgical stress: T cells
Time Frame: Baseline, after resection, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in blood T cell count
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Baseline, after resection, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Surgical stress: Adrenocorticotropic hormone (ACTH)
Time Frame: After last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 15
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Changes in blood ACTH concentration
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After last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 15
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Surgical stress: Cortisol
Time Frame: Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in blood cortisol concentration
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Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Surgical stress: Adrenaline
Time Frame: Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in blood adrenaline concentration
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Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Surgical stress: Noradrenaline
Time Frame: Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in blood noradrenaline concentration
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Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-years cancer-specific survival
Time Frame: Randomization to 3 years after randomization
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Proportion of patients who have not died from colorectal cancer 3 years after randomization
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Randomization to 3 years after randomization
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3-years overall survival
Time Frame: Randomization to 3 years after randomization
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Proportion of patients who are alive 3 years after randomization
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Randomization to 3 years after randomization
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Carcinoembryonic antigen (CEA)
Time Frame: Baseline, postoperative day 15, 8 weeks after discharge
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Changes in blood CEA
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Baseline, postoperative day 15, 8 weeks after discharge
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Circulating tumor DNA (ctDNA)
Time Frame: Baseline, postoperative day 15, 8 weeks after discharge
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Changes in blood ctDNA
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Baseline, postoperative day 15, 8 weeks after discharge
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DNA methylation
Time Frame: Baseline, 3 days before surgery, 1 h before anesthesia, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in DNA methylation
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Baseline, 3 days before surgery, 1 h before anesthesia, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Exercise feasibility: Exercise sessions attendance rate
Time Frame: From baseline to 8 weeks after discharge
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Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100
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From baseline to 8 weeks after discharge
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Exercise feasibility: Relative dose intensity (RDI) of exercise
Time Frame: From baseline to 8 weeks after discharge
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RDI (%) of exercise, defined as prescribed exercise dose / performed exercise dose x 100
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From baseline to 8 weeks after discharge
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Exercise feasibility: Early termination of exercise sessions
Time Frame: From baseline to 8 weeks after discharge
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Incidence of early termination of attended exercise sessions, defined as termination of an exercise session before the prescribed exercises have been performed
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From baseline to 8 weeks after discharge
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Exercise feasibility: Exercise intervention interruptions
Time Frame: From baseline to 8 weeks after discharge
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Incidence of exercise intervention disruptions, defined as a period of ≥ 7 days without an attended exercise session
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From baseline to 8 weeks after discharge
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Exercise feasibility: Exercise sessions requiring dose modifications
Time Frame: From baseline to 8 weeks after discharge
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Incidence of exercise sessions requiring dose modifications, defined as any deviation from the prescribed exercise
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From baseline to 8 weeks after discharge
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Exercise feasibility: Permanent discontinuation of the exercise intervention
Time Frame: From baseline to 8 weeks after discharge
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Incidence of permanent discontinuations of the exercise intervention, defined as participants that withdraw entirely from the exercise intervention, regardless of whether they remain in the trial
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From baseline to 8 weeks after discharge
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Exercise feasibility: Time from discharge to initiation of postoperative exercise
Time Frame: From surgery to 8 weeks after discharge
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Time from discharge to first attended postoperative exercise session
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From surgery to 8 weeks after discharge
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Exercise feasibility: Patient-reported symptomatic adverse events (paint, dizziness, nausea, fatigue, other)
Time Frame: Immediately before and immediately after each exercise session performed from baseline to 8 weeks after discharge
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Changes in patient-reported symptomatic adverse events (paint, dizziness, nausea, fatigue, other)
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Immediately before and immediately after each exercise session performed from baseline to 8 weeks after discharge
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Intraoperative factors: Blood loss during surgery
Time Frame: During surgery
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Blood loss during surgery
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During surgery
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Intraoperative factors: Duration of surgery
Time Frame: During surgery
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Duration of surgery
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During surgery
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Intraoperative factors: Blood transfusions
Time Frame: During surgery
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Incidence of blood transfusions
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During surgery
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Resting cardiovascular factors: Resting systolic blood pressure
Time Frame: Baseline, 8 weeks after discharge
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Changes in resting systolic blood pressure
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Baseline, 8 weeks after discharge
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Resting cardiovascular factors: Resting diastolic blood pressure
Time Frame: Baseline, 8 weeks after discharge
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Changes in resting diastolic blood pressure
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Baseline, 8 weeks after discharge
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Resting cardiovascular factors: Resting heart rate
Time Frame: Baseline, 8 weeks after discharge
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Changes in resting heart rate
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Baseline, 8 weeks after discharge
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Resting cardiovascular factors: Hemoglobin concentration
Time Frame: Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in hemoglobin concentration
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Baseline, after last incision, after resection, 3 hour post-surgery, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Aerobic capacity: Peak oxygen consumption
Time Frame: Baseline, 8 weeks after discharge
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Changes in peak oxygen consumption assessed during an incremental exercise test (ergometer bicycling) to volitional exhaustion
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Baseline, 8 weeks after discharge
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Aerobic capacity: Ventilatory threshold
Time Frame: Baseline, 8 weeks after discharge
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Changes in ventilatory threshold assessed during an incremental exercise test (ergometer bicycling) to volitional exhaustion
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Baseline, 8 weeks after discharge
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Aerobic capacity: Peak power output
Time Frame: Baseline, 8 weeks after discharge
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Changes in peak power output assessed during an incremental exercise test (ergometer bicycling) to volitional exhaustion
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Baseline, 8 weeks after discharge
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Muscle strength: Leg press maximal muscle strength
Time Frame: Baseline, 8 weeks after discharge
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Changes in leg press one repetition maximum (1RM)
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Baseline, 8 weeks after discharge
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Muscle strength: Chest press muscle strength
Time Frame: Baseline, 8 weeks after discharge
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Changes in chest press 1RM
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Baseline, 8 weeks after discharge
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Muscle strength: Hand grip strength
Time Frame: Baseline, 8 weeks after discharge
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Changes in hand grip strength, assessed using a dynamometer
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Baseline, 8 weeks after discharge
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Functional performance: Habitual gait speed
Time Frame: Baseline, 8 weeks after discharge
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Changes in habitual gait speed
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Baseline, 8 weeks after discharge
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Functional performance: Maximal gait speed
Time Frame: Baseline, 8 weeks after discharge
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Changes in maximal gait speed
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Baseline, 8 weeks after discharge
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Functional performance: Stair climbing power
Time Frame: Baseline, 8 weeks after discharge
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Changes in stair climbing power
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Baseline, 8 weeks after discharge
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Body composition and anthropometrics: Body mass
Time Frame: Baseline, 8 weeks after discharge
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Changes in body mass
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Baseline, 8 weeks after discharge
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Body composition and anthropometrics: Body mass index
Time Frame: Baseline, 8 weeks after discharge
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Changes in body mass index
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Baseline, 8 weeks after discharge
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Body composition and anthropometrics: Total lean mass
Time Frame: Baseline, 8 weeks after discharge
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Changes in total lean mass, assessed by dual energy x-ray absorptiometry (DXA)
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Baseline, 8 weeks after discharge
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Body composition and anthropometrics: Appendicular lean mass
Time Frame: Baseline, 8 weeks after discharge
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Changes in appendicular lean mass, assessed by DXA
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Baseline, 8 weeks after discharge
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Body composition and anthropometrics: Abdominal fat mass
Time Frame: Baseline, 8 weeks after discharge
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Changes in abdominal fat mass, assessed by DXA
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Baseline, 8 weeks after discharge
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Body composition and anthropometrics: Total fat mass
Time Frame: Baseline, 8 weeks after discharge
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Changes in total fat mass, assessed by DXA
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Baseline, 8 weeks after discharge
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Body composition and anthropometrics: Fat percentage
Time Frame: Baseline, 8 weeks after discharge
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Changes in fat percentage, assessed by DXA
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Baseline, 8 weeks after discharge
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Body composition and anthropometrics: Hip circumference
Time Frame: Baseline, 8 weeks after discharge
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Changes in hip circumference
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Baseline, 8 weeks after discharge
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Body composition and anthropometrics: Waist circumference
Time Frame: Baseline, 8 weeks after discharge
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Changes in waist circumference
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Baseline, 8 weeks after discharge
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Standard blood biochemistry: Total cholesterol
Time Frame: Baseline, 8 weeks after discharge
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Changes in total cholesterol concentration
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Baseline, 8 weeks after discharge
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Standard blood biochemistry: Low-density lipoprotein cholesterol
Time Frame: Baseline, 8 weeks after discharge
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Changes in low-density lipoprotein cholesterol concentration
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Baseline, 8 weeks after discharge
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Standard blood biochemistry: High-density lipoprotein cholesterol
Time Frame: Baseline, 8 weeks after discharge
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Changes in high-density lipoprotein cholesterol concentration
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Baseline, 8 weeks after discharge
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Standard blood biochemistry: Triglyceride
Time Frame: Baseline, 8 weeks after discharge
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Changes in triglyceride concentration
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Baseline, 8 weeks after discharge
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Standard blood biochemistry: Glycated hemoglobin A1c
Time Frame: Baseline, 8 weeks after discharge
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Change in glycated hemoglobin A1c concentration
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Baseline, 8 weeks after discharge
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Standard blood biochemistry: Insulin
Time Frame: Baseline, 8 weeks after discharge
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Changes in insulin concentration
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Baseline, 8 weeks after discharge
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Standard blood biochemistry: Glucose
Time Frame: Baseline, 8 weeks after discharge
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Changes in blood glucose concentration
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Baseline, 8 weeks after discharge
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Health-related quality of life: Physical well-being
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported physical well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C)
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Health-related quality of life: Social well-being
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported social well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C)
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Health-related quality of life: Emotional well-being
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported emotional well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C).
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Health-related quality of life: Functional well-being
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported functional well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C).
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Health-related quality of life: Colorectal-cancer specific
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported colorectal-cancer specific health-related quality of life assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C).
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Health-related quality of life: General
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported general health-related qualify of life assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C).
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Health-related quality of life: Trial outcome index
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported trial outcome index assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C).
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Health-related quality of life: Total score (Functional Assessment of Cancer Therapy - Colorectal)
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported in health-related quality of life (total score) assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C).
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Depression
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported depression, assessed using the Hospital Anxiety and Depression Scale (HADS).
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Anxiety
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS).
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Self-reported physical activity: Walking
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported weekly duration of walking, assessed using the International Physical Activity Questionnaire (IPAQ)
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Self-reported physical activity: Moderate intensity physical activity (PA)
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported weekly duration of moderate intensity PA, assessed using the International Physical Activity Questionnaire (IPAQ)
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Self-reported physical activity: Vigorous intensity physical activity (PA)
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported weekly duration of vigorous intensity PA, assessed using the International Physical Activity Questionnaire (IPAQ)
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Self-reported physical activity: Total physical activity (PA)
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported weekly duration of total PA, assessed using the International Physical Activity Questionnaire (IPAQ)
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Self-reported physical activity: Sitting time
Time Frame: Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Changes in patient-reported weekly sitting time, assessed using the International Physical Activity Questionnaire (IPAQ)
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Baseline, 8 weeks after discharge, 1 year after randomization, 2 years after randomization, 3 years after randomization
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Effect of acute perioperative exercise: IL-1β
Time Frame: 10 min before exercise, immediately after aerobic exercise
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Changes in blood IL-1β concentration during acute perioperative exercise
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10 min before exercise, immediately after aerobic exercise
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Effect of acute perioperative exercise: IL-6
Time Frame: 10 min before exercise, immediately after aerobic exercise
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Changes in blood IL-6 concentration during acute perioperative exercise
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10 min before exercise, immediately after aerobic exercise
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Effect of acute perioperative exercise: IL-8
Time Frame: 10 min before exercise, immediately after aerobic exercise
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Changes in blood IL-8 concentration during acute perioperative exercise
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10 min before exercise, immediately after aerobic exercise
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Effect of acute perioperative exercise: IL-10
Time Frame: 10 min before exercise, immediately after aerobic exercise
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Changes in blood IL-10 concentration during acute perioperative exercise
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10 min before exercise, immediately after aerobic exercise
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Effect of acute perioperative exercise: Interferon- γ
Time Frame: 10 min before exercise, immediately after aerobic exercise
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Changes in blood interferon- γ concentration during acute perioperative exercise
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10 min before exercise, immediately after aerobic exercise
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Effect of acute perioperative exercise: C-reactive protein
Time Frame: 10 min before exercise, immediately after aerobic exercise
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Changes in blood C-reactive protein concentration during acute perioperative exercise
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10 min before exercise, immediately after aerobic exercise
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Effect of acute perioperative exercise: Leukocyte differential counts
Time Frame: 10 min before exercise, immediately after aerobic exercise
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Changes in blood leukocyte cell counts (total and per type [eosinophils, basophils, lymphocytes, monocytes, neutrophils]) during acute perioperative exercise
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10 min before exercise, immediately after aerobic exercise
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Effect of acute perioperative exercise: Natural killer cells
Time Frame: 10 min before exercise, immediately after aerobic exercise
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Changes in blood natural killer cell count during acute perioperative exercise
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10 min before exercise, immediately after aerobic exercise
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Effect of acute perioperative exercise: T cells
Time Frame: 10 min before exercise, immediately after aerobic exercise
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Changes in blood T cell count during acute perioperative exercise
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10 min before exercise, immediately after aerobic exercise
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Effect of acute perioperative exercise: Adrenocorticotropic hormone (ACTH)
Time Frame: 10 min before exercise, immediately after aerobic exercise
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Changes in blood ACTH concentration during acute perioperative exercise
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10 min before exercise, immediately after aerobic exercise
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Effect of acute perioperative exercise: Cortisol
Time Frame: 10 min before exercise, immediately after aerobic exercise
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Changes in blood cortisol concentration during acute perioperative exercise
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10 min before exercise, immediately after aerobic exercise
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Effect of acute perioperative exercise: Adrenaline
Time Frame: 10 min before exercise, immediately after aerobic exercise
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Changes in blood adrenaline concentration during acute perioperative exercise
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10 min before exercise, immediately after aerobic exercise
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Effect of acute perioperative exercise: Noradrenaline
Time Frame: 10 min before exercise, immediately after aerobic exercise
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Changes in blood noradrenaline concentration during acute perioperative exercise
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10 min before exercise, immediately after aerobic exercise
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LPS-induced IL-6 production of whole blood
Time Frame: Baseline, after resection, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in concentation of IL-6 in LPS-stumulated whole blood
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Baseline, after resection, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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LPS-induced TNF-a production of whole blood
Time Frame: Baseline, after resection, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Changes in concentation of TNF-a in LPS-stumulated whole blood
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Baseline, after resection, postoperative day 1, postoperative day 3, postoperative day 15, 8 weeks after discharge
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jesper F Christensen, PhD, Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ELMA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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