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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

Tracking Information
First Submitted Date  ICMJE November 17, 2014
First Posted Date  ICMJE November 24, 2014
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2016)
Recovery measured as physical recovery measured in questionnaire [ Time Frame: 4-6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
Recovery measured as time back to work [ Time Frame: 4 weeks postoperatively ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
  • Psychological recovery measured in a questionnaire, patient reported [ Time Frame: 1 year postoperatively ]
  • Physical recovery measured in a questionnaire, patient reported [ Time Frame: 1 year postoperatively ]
  • Complications according to Clavien-Dindo [ Time Frame: 1 year postoperatively ]
  • Resumption to QoL measured in a questionnaire, patient reported [ Time Frame: 1 year ]
  • Postoperative recovery measured by SF-36 [ Time Frame: 1 month ]
  • Health economic analysis of resource consumption 12 months postoperatively using EQ5D. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Activity in Relation to Surgical Procedures
Official Title  ICMJE Physsurg - a Controlled Randomized Trial on the Effect of Physical Activity in Relation to Outcome After Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Colorectal Cancer
  • Surgery
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

    Intervention: Other: Physical activity
  • No Intervention: Control
    Standard treatment with one exception, patients will fill in a physical activity diary
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2016)
620
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2014)
370
Estimated Study Completion Date  ICMJE September 2022
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed colorectal cancer and a planned surgical procedure

Exclusion Criteria:

  • HIPEC surgery, not able to give informed consent or understand the intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02299596
Other Study ID Numbers  ICMJE Physsurg C - the RCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Eva Haglind, MD, PhD, professor, Sahlgrenska University Hospital, Sweden
Study Sponsor  ICMJE Sahlgrenska University Hospital, Sweden
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eva Haglind, M.D., Ph.D. SSORG
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP