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Physical Activity in Relation to Surgical Procedures

Primary Purpose

Colorectal Cancer, Surgery

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physical activity
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring Colorectal neoplasm, Physical activity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed colorectal cancer and a planned surgical procedure

Exclusion Criteria:

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

Sites / Locations

  • Sahlgrenska University Hospital/Östra
  • Dept. of Surgery, Skaraborgs Sjukhus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pre and postoperative exercise

Control

Arm Description

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.

Standard treatment with one exception, patients will fill in a physical activity diary

Outcomes

Primary Outcome Measures

Recovery measured as physical recovery measured in questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2014
Last Updated
May 4, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02299596
Brief Title
Physical Activity in Relation to Surgical Procedures
Official Title
Physsurg - a Controlled Randomized Trial on the Effect of Physical Activity in Relation to Outcome After Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2015 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Surgery
Keywords
Colorectal neoplasm, Physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
761 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre and postoperative exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard treatment with one exception, patients will fill in a physical activity diary
Intervention Type
Other
Intervention Name(s)
Physical activity
Intervention Description
The intervention will take place both pre- and postoperatively. During the hospital stay both groups will be treated in the same manner.
Primary Outcome Measure Information:
Title
Recovery measured as physical recovery measured in questionnaire
Time Frame
4-6 weeks
Secondary Outcome Measure Information:
Title
Psychological recovery measured in a questionnaire, patient reported
Description
Recovery
Time Frame
4-6 weeks and 1 year post-operatively
Title
Recovery measured as time back to work
Description
Recovery
Time Frame
1 year
Title
Complications according to Clavien-Dindo
Description
Postoperative complications
Time Frame
within 90 days
Title
QoL measured using SF-36
Description
QoL according to SF-36
Time Frame
4-6 weeks and 1 year
Title
QoL measured using EQ-5D
Description
QoL according to EQ-5D
Time Frame
4-6 weeks and 1 year
Title
QoL measured using a specifically developed instrument for this study
Description
Health related QoL
Time Frame
4-6 weeks and 1 year
Title
Mortality
Description
Long term mortality
Time Frame
3 and 5 years
Title
Re-admissions
Description
Hospital re-admissions
Time Frame
1 year
Title
Reoperations
Description
Reoperations
Time Frame
1 year
Title
Total time of hospital stay
Description
Length of stay
Time Frame
1 year
Title
IGF-1 and IGFBP-3
Description
Lab values
Time Frame
4 weeks postopeartively
Title
Postoperative pain measured with Brief Pain Inventory-Short form
Description
Pain measured by BPI-S
Time Frame
4 weeks
Title
Postoperative pain measured with Brief Pain Inventory-Short form
Description
Pain measured by BPI-S
Time Frame
12 months
Title
Health economic analysis
Description
Health economic analysis modified according to results of primary outcome
Time Frame
4 weeks
Title
Health economic analysis
Description
Health economic analysis modified according to results of primary outcome
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed colorectal cancer and a planned surgical procedure Exclusion Criteria: HIPEC surgery, not able to give informed consent or understand the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Haglind, M.D., Ph.D.
Organizational Affiliation
SSORG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital/Östra
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
Facility Name
Dept. of Surgery, Skaraborgs Sjukhus
City
Skövde
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35588252
Citation
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.
Results Reference
derived
PubMed Identifier
32007834
Citation
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. Erratum In: Growth Horm IGF Res. 2021 Feb;56:101374.
Results Reference
derived
PubMed Identifier
28482864
Citation
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. Erratum In: Trials. 2020 Dec 23;21(1):1030.
Results Reference
derived

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Physical Activity in Relation to Surgical Procedures

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