Physical Activity in Relation to Surgical Procedures

Not Applicable

Active, not recruiting

• Conditions: Surgery; Colorectal Cancer
• Interventions: Other: Physical activity

• Registration Number: NCT02299596
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Study Start: 2015-01
• Primary Completion: 2020-05-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 761

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre and postoperative exercise	Physical activity	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.

Primary Outcome Measures

Name	Time	Method
Recovery measured as physical recovery measured in questionnaire	4-6 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Dept. of Surgery, Skaraborgs Sjukhus; 🇸🇪 Skövde, Sweden

Sahlgrenska University Hospital/Östra; 🇸🇪 Göteborg, Sweden