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Completed

NCT Number: NCT02299596

Physical Activity in Relation to Surgical Procedures

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.

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Key information

Conditions

Colorectal Cancer Behavior Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Motor Activity Neoplasms Neoplasms by Site Rectal Diseases Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital/Östra, Gothenburg, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed colorectal cancer and a planned surgical procedure

Exclusion criteria

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

Treatment and study plan

Physical activity

Other

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

Primary outcomes

  1. Recovery measured as physical recovery measured in questionnaire

    Time frame: 4-6 weeks

Secondary outcomes

  1. Psychological recovery measured in a questionnaire, patient reported

    Time frame: 4-6 weeks and 1 year post-operatively

    Recovery

  2. Recovery measured as time back to work

    Time frame: 1 year

    Recovery

  3. Complications according to Clavien-Dindo

    Time frame: within 90 days

    Postoperative complications

  4. QoL measured using SF-36

    Time frame: 4-6 weeks and 1 year

    QoL according to SF-36

  5. QoL measured using EQ-5D

    Time frame: 4-6 weeks and 1 year

    QoL according to EQ-5D

  6. QoL measured using a specifically developed instrument for this study

    Time frame: 4-6 weeks and 1 year

    Health related QoL

  7. Mortality

    Time frame: 3 and 5 years

    Long term mortality

  8. Re-admissions

    Time frame: 1 year

    Hospital re-admissions

  9. Reoperations

    Time frame: 1 year

    Reoperations

  10. Total time of hospital stay

    Time frame: 1 year

    Length of stay

  11. IGF-1 and IGFBP-3

    Time frame: 4 weeks postopeartively

    Lab values

  12. Postoperative pain measured with Brief Pain Inventory-Short form

    Time frame: 4 weeks

    Pain measured by BPI-S

  13. Postoperative pain measured with Brief Pain Inventory-Short form

    Time frame: 12 months

    Pain measured by BPI-S

  14. Health economic analysis

    Time frame: 4 weeks

    Health economic analysis modified according to results of primary outcome

  15. Health economic analysis

    Time frame: 12 months

    Health economic analysis modified according to results of primary outcome

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2025
First posted
Nov 24, 2014
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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