NCT02299596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
761

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

5.4 years

First QC Date

November 17, 2014

Last Update Submit

April 22, 2026

Conditions

Keywords

Colorectal neoplasmPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Recovery measured as physical recovery measured in questionnaire

    4-6 weeks

Secondary Outcomes (15)

  • Psychological recovery measured in a questionnaire, patient reported

    4-6 weeks and 1 year post-operatively

  • Recovery measured as time back to work

    1 year

  • Complications according to Clavien-Dindo

    within 90 days

  • QoL measured using SF-36

    4-6 weeks and 1 year

  • QoL measured using EQ-5D

    4-6 weeks and 1 year

  • +10 more secondary outcomes

Study Arms (2)

Pre and postoperative exercise

EXPERIMENTAL

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.

Other: Physical activity

Control

NO INTERVENTION

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

Interventions

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

Pre and postoperative exercise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed colorectal cancer and a planned surgical procedure

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sahlgrenska University Hospital/Östra

Gothenburg, 416 85, Sweden

Location

Dept. of Surgery, Skaraborgs Sjukhus

Skövde, Sweden

Location

Related Publications (5)

  • Onerup A, Li Y, Afshari K, Angenete E, de la Croix H, Ehrencrona C, Wedin A, Haglind E. Long-term results of a short-term home-based pre- and postoperative exercise intervention on physical recovery after colorectal cancer surgery (PHYSSURG-C): a randomized clinical trial. Colorectal Dis. 2024 Mar;26(3):545-553. doi: 10.1111/codi.16860. Epub 2024 Jan 15.

  • 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. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Colorectal NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Eva Haglind, M.D., Ph.D.

    SSORG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon, Professor

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 24, 2014

Study Start

January 1, 2015

Primary Completion

May 31, 2020

Study Completion

December 31, 2025

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations