Physical Activity in Relation to Surgical Procedures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02299596|
Recruitment Status : Active, not recruiting
First Posted : November 24, 2014
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Surgery||Other: Physical activity||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||620 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Physsurg - a Controlled Randomized Trial on the Effect of Physical Activity in Relation to Outcome After Surgery|
|Actual Study Start Date :||January 2015|
|Actual Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||September 2022|
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.
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
The intervention will take place both pre- and postoperatively. During the hospital stay both groups will be treated in the same manner.
No Intervention: Control
Standard treatment with one exception, patients will fill in a physical activity diary
- Recovery measured as physical recovery measured in questionnaire [ Time Frame: 4-6 weeks ]
- Psychological recovery measured in a questionnaire, patient reported [ Time Frame: 4-6 weeks and 1 year post-operatively ]Recovery
- Recovery measured as time back to work [ Time Frame: 1 year ]Recovery
- Complications according to Clavien-Dindo [ Time Frame: within 90 days ]Postoperative complications
- QoL measured using SF-36 [ Time Frame: 4-6 weeks and 1 year ]QoL according to SF-36
- QoL measured using EQ-5D [ Time Frame: 4-6 weeks and 1 year ]QoL according to EQ-5D
- QoL measured using a specifically developed instrument for this study [ Time Frame: 4-6 weeks and 1 year ]Health related QoL
- Mortality [ Time Frame: 3 and 5 years ]Long term mortality
- Re-admissions [ Time Frame: 1 year ]Hospital re-admissions
- Reoperations [ Time Frame: 1 year ]Reoperations
- Total time of hospital stay [ Time Frame: 1 year ]Length of stay
- IGF-1 and IGFBP-3 [ Time Frame: 4 weeks postopeartively ]Lab values
- Postoperative pain measured with Brief Pain Inventory-Short form [ Time Frame: 4 weeks ]Pain measured by BPI-S
- Postoperative pain measured with Brief Pain Inventory-Short form [ Time Frame: 12 months ]Pain measured by BPI-S
- Health economic analysis [ Time Frame: 4 weeks ]Health economic analysis modified according to results of primary outcome
- Health economic analysis [ Time Frame: 12 months ]Health economic analysis modified according to results of primary outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299596
|Sahlgrenska University Hospital/Östra|
|Göteborg, Sweden, 416 85|
|Dept. of Surgery, Skaraborgs Sjukhus|
|Principal Investigator:||Eva Haglind, M.D., Ph.D.||SSORG|