Clinical trial NCT02299596: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Surgery
Keywords: Colorectal neoplasm
Physical activity
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 761
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Recovery measured as physical recovery measured in questionnaire
timeFrame: 4-6 weeks
Secondary outcomes:
measure: Psychological recovery measured in a questionnaire, patient reported
timeFrame: 4-6 weeks and 1 year post-operatively
measure: Recovery measured as time back to work
timeFrame: 1 year
measure: Complications according to Clavien-Dindo
timeFrame: within 90 days
measure: QoL measured using SF-36
timeFrame: 4-6 weeks and 1 year
measure: QoL measured using EQ-5D
timeFrame: 4-6 weeks and 1 year
measure: QoL measured using a specifically developed instrument for this study
timeFrame: 4-6 weeks and 1 year
measure: Mortality
timeFrame: 3 and 5 years
measure: Re-admissions
timeFrame: 1 year
measure: Reoperations
timeFrame: 1 year
measure: Total time of hospital stay
timeFrame: 1 year
measure: IGF-1 and IGFBP-3
timeFrame: 4 weeks postopeartively
measure: Postoperative pain measured with Brief Pain Inventory-Short form
timeFrame: 4 weeks
measure: Postoperative pain measured with Brief Pain Inventory-Short form
timeFrame: 12 months
measure: Health economic analysis
timeFrame: 4 weeks
measure: Health economic analysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital/Östra
city: Skövde
country: Sweden
facility: Dept. of Surgery, Skaraborgs Sjukhus
Study officials:
affiliation: SSORG
name: Eva Haglind, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.