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Exercise for Adults Diagnosed With Rectal Cancer

6 mars 2020 uppdaterad av: Jennifer Brunet, University of Ottawa

Exercise for Adults Diagnosed With Rectal Cancer: A Feasibility Study

Currently, there is no clear indication if exercise is safe and if it confers health benefits for adults across the cancer trajectory (i.e., from diagnosis onward) for rectal cancer - a population who may have limited exercise tolerance and who may be at an increased risk for adverse events associated with exercise. In this prospective single-arm feasibility trial, we aim to examine the safety and feasibility of a 12-week exercise intervention for adults diagnosed with rectal cancer to inform the development of a large-scale randomized controlled trial that will assess the efficacy of exercise administered across the cancer trajectory for for rectal cancer. Adults who have been diagnosed with rectal cancer and are currently undergoing or have completed treatment (within the last five years) will be recruited over a 12-month period into a supervised exercise intervention consisting of aerobic and strength training to be done three times per week. Feasibility, safety, patient-reported outcomes, and physical tests will be performed pre-intervention and post-intervention. This study will provide data on the feasibility of an exercise intervention and will help determine if it is safe to progress with a large-scale randomized controlled trial to test the benefits of exercise for adults diagnosed with rectal cancer. It will also provide initial estimates of the parameters for patient-reported outcomes, which are required to calculate the sample size for the large-scale randomized controlled trial to ensure it is sufficiently powered.

The purpose of this prospective single-arm feasibility trial is to determine if a 12-week exercise intervention offered to adults diagnosed with rectal cancer surviviors is safe and feasible.

The specific objectives are to:

  1. Test the feasibility and safety of a 12-week exercise intervention;
  2. Obtain initial estimates of the parameters of the main outcomes to inform sample size calculations for the main study (i.e., means and standard deviations for patient-reported and physical outcomes);
  3. Determine the opportune time in the cancer trajectory for rectal cancer to deliver a 12-week exercise intervention.

Studieöversikt

Status

Indragen

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kanada
    • Ontario
      • Ottawa, Ontario, Kanada, K1N 6N5
        • University of Ottawa

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 85 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion criteria are:

  1. Men and women 18 to 85 years of age;
  2. Diagnosed and/or completed treatment for stage I-III rectal cancer within the last 5 years;
  3. Able to read/understand English or French;
  4. Ambulatory;
  5. Live <50km of the University of Ottawa;
  6. Approval of healthcare provider to participate in the intervention.

Exclusion criteria are:

  1. Congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, uncontrolled angina, uncontrolled arrhythmia, myocardial infarction, major heart surgery, stroke, or pulmonary embolus;
  2. A diagnosis of hypertension or a resting blood pressure of 160/90 mmHg or higher (i.e., systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg);
  3. The use of supplemental oxygen;
  4. Severe arthritis (i.e., osteoarthritis or rheumatoid arthritis);
  5. History of chest pain or severe shortness of breath either at rest or when engaging in physical activity;
  6. Hip fracture, hip or knee replacement in the past 6 months;
  7. Impairments requiring mobility aids;
  8. Stage V cancer;
  9. Prior cancer diagnosis, excluding non-melanoma skin cancer;
  10. Participating in another exercise trial;
  11. Unwilling/unable to give informed consent.

Of note, in addition to the exclusion criteria listed above, for individuals who are about to begin or are undergoing treatment healthcare providers will also employ clinical judgment concerning participant safety; that is, if the healthcare provider judges the patient to be at high risk for adverse events or medical complications if they participate in the intervention given their health status, they will not approach the patient to obtain permission for research personnel from the University of Ottawa to contact them.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Exercise
Participants will be asked to complete a 12-week exercise intervention and all study assessments.
Beteende: Exercise
Participants will engage in supervised exercise 3 times per week for 60-75 minutes/session for 12 weeks. Sessions will include a warm-up (aerobic activity less than < 60% of heart rate reserve), aerobic training (30 minutes of exercise at 60-75% of heart rate reserve, using cycle ergometers/treadmills), strength training (8 exercises; upper body, lower body, and core), and a cool-down (aerobic activity less than < 60% of heart rate reserve) component.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Recruitment Rates
Tidsram: Through study completion, an average of 12 weeks
The number of eligible participants who enrol in the study out of the number who are referred.
Through study completion, an average of 12 weeks
Retention Rates
Tidsram: Through study completion, an average of 12 weeks
The number of participants completing the intervention and all scheduled assessments.
Through study completion, an average of 12 weeks
Adherence Rates
Tidsram: Through study completion, an average of 12 weeks
The number of exercise sessions completed out of 36.
Through study completion, an average of 12 weeks
Number of Participants with Adverse Events
Tidsram: Through study completion, an average of 12 weeks
The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the exercise sessions and/or its assessments.
Through study completion, an average of 12 weeks

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Socio-Demographic and Medical Information Questionnaire
Tidsram: Baseline (week 0)
The socio-demographic and medical information collected will be used to describe the sample.
Baseline (week 0)
Quality of Life: Functional Assessment of Cancer Therapy - Colorectal (Ward et al., 1999; Yost et al., 2005)
Tidsram: Baseline (week 0) and post-intervention (week 12)
Change in self-reported quality of life from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Cognitive Functioning: Functional Assessment of Cancer Therapy - Cognitive Function (Wagner et al., 2004)
Tidsram: Baseline (week 0) and post-intervention (week 12)
Change in self-reported cognitive function from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Symptoms of Fatigue: the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (Yellen et al., 1997)
Tidsram: Baseline (week 0) and post-intervention (week 12)
Change in self-reported fatigue from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Affect: Positive and Negative Affect Schedule (Watson et al., 1988)
Tidsram: Baseline (week 0) and post-intervention (week 12)
Change in self-reported affect from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Tidsram: Baseline (week 0) and post-intervention (week 12)
Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Resting Heart Rate: Heart Rate Monitor (Polar A300)
Tidsram: Baseline (week 0) and post-intervention (week 12)
Change in resting heart rate from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Blood Pressure: Blood Pressure Monitor (HealthSmart Digital Blood Pressure Monitor)
Tidsram: Baseline (week 0) and post-intervention (week 12)
Change in resting blood pressure from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Body Mass Index: Tanita Scale (TBF-310 GS)
Tidsram: Baseline (week 0) and post-intervention (week 12)
Change in body mass index from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Aerobic Capacity: 6-Minute Walk Test (Canadian Society for Exercise Physiology, 2013; Irwin, 2012)
Tidsram: Baseline (week 0) and post-intervention (week 12)
Change in aerobic capacity (i.e., total distance walked in 6 minutes) from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Musculoskeletal Strength: Combined Grip Strength Using a Handheld Dynamometer (Canadian Society for Exercise Physiology, 2013, 2013; Irwin, 2012)
Tidsram: Baseline (week 0) and post-intervention (week 12)
Change in musculoskeletal strength (i.e., force exerted in kilograms on the handheld dynamometer) from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Ottawa

Utredare

  • Huvudutredare: Jennifer Brunet, PhD, University of Ottawa

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 november 2017

Primärt slutförande (Faktisk)

4 december 2019

Avslutad studie (Faktisk)

4 december 2019

Studieregistreringsdatum

Först inskickad

7 februari 2017

Först inskickad som uppfyllde QC-kriterierna

8 februari 2017

Första postat (Uppskatta)

9 februari 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 mars 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 mars 2020

Senast verifierad

1 mars 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RectalCaEx-JB-MV-KC

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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