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Physical Activity in Relation to Surgical Procedures

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ClinicalTrials.gov Identifier: NCT02299596
Recruitment Status : Active, not recruiting
First Posted : November 24, 2014
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Eva Haglind, MD, PhD, professor, Sahlgrenska University Hospital, Sweden

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Surgery Other: Physical activity Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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
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



Primary Outcome Measures :
  1. Recovery measured as physical recovery measured in questionnaire [ Time Frame: 4-6 weeks ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Sweden
Sahlgrenska University Hospital/Östra
Göteborg, Sweden, 416 85
Dept. of Surgery, Skaraborgs Sjukhus
Skövde, Sweden
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Eva Haglind, M.D., Ph.D. SSORG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eva Haglind, MD, PhD, professor, Consultant Surgeon, Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02299596    
Other Study ID Numbers: Physsurg C - the RCT
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Eva Haglind, MD, PhD, professor, Sahlgrenska University Hospital, Sweden:
Colorectal neoplasm
Physical activity
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases