Physical Activity in Relation to Surgical Procedures

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02299596
• Other study ID #: Physsurg C - the RCT
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 761
• Est. completion date: December 31, 2025
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosed colorectal cancer and a planned surgical procedure

Exclusion Criteria:

• HIPEC surgery, not able to give informed consent or understand the intervention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Surgery

Intervention

Other:
• Physical activity
The intervention will take place both pre- and postoperatively. During the hospital stay both groups will be treated in the same manner.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital/Östra	Göteborg
Sweden	Dept. of Surgery, Skaraborgs Sjukhus	Skövde

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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