Physical Activity in Relation to Surgical Procedures

Study Overview
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Brief Summary
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This study will compare the outcome after surgery between a group of patients that receives instructions for prehabilitation training and one group that received standard treatment.

Detailed Description
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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.

Official Title
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Physsurg - a Controlled Randomized Trial on the Effect of Physical Activity in Relation to Outcome After Surgery

Conditions
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Colorectal Cancer, Surgery

Intervention / Treatment
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* Other: Physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed colorectal cancer and a planned surgical procedure Exclusion Criteria: HIPEC surgery, not able to give informed consent or understand the intervention
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre and postoperative exercise<br>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. | Other: Physical activity<br>* The intervention will take place both pre- and postoperatively. During the hospital stay both groups will be treated in the same manner.<br>|
| No Intervention: Control<br>Standard treatment with one exception, patients will fill in a physical activity diary | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery measured as physical recovery measured in questionnaire |  | 4-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological recovery measured in a questionnaire, patient reported | Recovery | 4-6 weeks and 1 year post-operatively | 
| Recovery measured as time back to work | Recovery | 1 year | 
| Complications according to Clavien-Dindo | Postoperative complications | within 90 days | 
| QoL measured using SF-36 | QoL according to SF-36 | 4-6 weeks and 1 year | 
| QoL measured using EQ-5D | QoL according to EQ-5D | 4-6 weeks and 1 year | 
| QoL measured using a specifically developed instrument for this study | Health related QoL | 4-6 weeks and 1 year | 
| Mortality | Long term mortality | 3 and 5 years | 
| Re-admissions | Hospital re-admissions | 1 year | 
| Reoperations | Reoperations | 1 year | 
| Total time of hospital stay | Length of stay | 1 year | 
| IGF-1 and IGFBP-3 | Lab values | 4 weeks postopeartively | 
| Postoperative pain measured with Brief Pain Inventory-Short form | Pain measured by BPI-S | 4 weeks | 
| Postoperative pain measured with Brief Pain Inventory-Short form | Pain measured by BPI-S | 12 months | 
| Health economic analysis | Health economic analysis modified according to results of primary outcome | 4 weeks | 
| Health economic analysis | Health economic analysis modified according to results of primary outcome | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal neoplasm, Physical activity