- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02299596
Physical Activity in Relation to Surgical Procedures
Physsurg - a Controlled Randomized Trial on the Effect of Physical Activity in Relation to Outcome After Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to investigate whether a training program with intensified physical activity prior to and after a surgical procedure reduces the surgical-related postoperative recovery time, hospital stay, sick leave and complication rate.
A secondary aim is to investigate the effect of a training program with pre- and post- operative PA on the rate of resumption of QoL and normal physical function.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Gothenburg, Sweden, 416 85
- Sahlgrenska University Hospital/Östra
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Skövde, Sweden
- Dept. of Surgery, Skaraborgs Sjukhus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed colorectal cancer and a planned surgical procedure
Exclusion Criteria:
- HIPEC surgery, not able to give informed consent or understand the intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pre and postoperative exercise
The intervention is prehabilitation preoperatively and physical training postoperatively. During the hospital stay both groups will be treated in the same manner. Preoperative intervention: One half hour of exercise daily added to the existing daily exercise routine. The level of exercise should produce shortness of breath but the patient should be able to talk without much effort. Inspiratory muscle training. Thirty breaths x two twice daily. Postoperative intervention is mainly the same as preoperatively. |
The intervention will take place both pre- and postoperatively.
During the hospital stay both groups will be treated in the same manner.
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No Intervention: Control
Standard treatment with one exception, patients will fill in a physical activity diary
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Recovery measured as physical recovery measured in questionnaire
Time Frame: 4-6 weeks
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4-6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological recovery measured in a questionnaire, patient reported
Time Frame: 4-6 weeks and 1 year post-operatively
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Recovery
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4-6 weeks and 1 year post-operatively
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Recovery measured as time back to work
Time Frame: 1 year
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Recovery
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1 year
|
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Complications according to Clavien-Dindo
Time Frame: within 90 days
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Postoperative complications
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within 90 days
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QoL measured using SF-36
Time Frame: 4-6 weeks and 1 year
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QoL according to SF-36
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4-6 weeks and 1 year
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QoL measured using EQ-5D
Time Frame: 4-6 weeks and 1 year
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QoL according to EQ-5D
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4-6 weeks and 1 year
|
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QoL measured using a specifically developed instrument for this study
Time Frame: 4-6 weeks and 1 year
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Health related QoL
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4-6 weeks and 1 year
|
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Mortality
Time Frame: 3 and 5 years
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Long term mortality
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3 and 5 years
|
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Re-admissions
Time Frame: 1 year
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Hospital re-admissions
|
1 year
|
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Reoperations
Time Frame: 1 year
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Reoperations
|
1 year
|
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Total time of hospital stay
Time Frame: 1 year
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Length of stay
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1 year
|
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IGF-1 and IGFBP-3
Time Frame: 4 weeks postopeartively
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Lab values
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4 weeks postopeartively
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Postoperative pain measured with Brief Pain Inventory-Short form
Time Frame: 4 weeks
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Pain measured by BPI-S
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4 weeks
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Postoperative pain measured with Brief Pain Inventory-Short form
Time Frame: 12 months
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Pain measured by BPI-S
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12 months
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Health economic analysis
Time Frame: 4 weeks
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Health economic analysis modified according to results of primary outcome
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4 weeks
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Health economic analysis
Time Frame: 12 months
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Health economic analysis modified according to results of primary outcome
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eva Haglind, M.D., Ph.D., SSORG
Publications and helpful links
General Publications
- Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
- Onerup A, Li Y, Afshari K, Angenete E, de la Croix H, Ehrencrona C, Wedin A, Haglind E. Long-term results of a short-term home-based pre- and postoperative exercise intervention on physical recovery after colorectal cancer surgery (PHYSSURG-C): a randomized clinical trial. Colorectal Dis. 2024 Mar;26(3):545-553. doi: 10.1111/codi.16860. Epub 2024 Jan 15.
- Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.
- Onerup A, Thorn SE, Angenete E, Bock D, Gryback Gillheimer E, Haglind E, Nilsson H. Effects of a home-based exercise program on the insulin-like growth factor axis in patients operated for colorectal cancer in Sweden: Results from the randomised controlled trial PHYSSURG-C. Growth Horm IGF Res. 2020 Apr;51:27-33. doi: 10.1016/j.ghir.2020.01.005. Epub 2020 Jan 28.
- Onerup A, Angenete E, Bock D, Borjesson M, Fagevik Olsen M, Gryback Gillheimer E, Skullman S, Thorn SE, Haglind E, Nilsson H. The effect of pre- and post-operative physical activity on recovery after colorectal cancer surgery (PHYSSURG-C): study protocol for a randomised controlled trial. Trials. 2017 May 8;18(1):212. doi: 10.1186/s13063-017-1949-9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Behavior
- Colorectal Neoplasms
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- Physsurg C - the RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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