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The Impact of Physical Activity on the Outcome of Surgery

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 16, 2012
Last Update Posted: November 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eva Angenete, Sahlgrenska University Hospital, Sweden

Over the last decades different life style factors have been established as risk factors for various diseases. The obesity pandemic displays a good example of a disease where great effort is undertaken to characterize risk factors associated with obesity (1). Smoking is another life style risk factor established since several decades, and where primary prevention has been increasingly successful (2, 3). Cardiovascular epidemiologic research at the University of Gothenburg recognized PA as a factor of importance early on and thus included PA related questions in the work up of studies with large cohorts (4-6). A 4-level scale was introduced in the late 1960:s by Saltin and Grimby (7) and has been used extensively since then. With this background it is of interest to record physical activity one year and one month prior to certain types of elective surgery and to study the relationship of PA to surgical complications and recovery is of interest.

The aim of this study is to investigate whether a higher physical activity prior to a surgical procedure reduces hospital stay, sick leave and the complication rate.

A secondary aim is to investigate the effect of preoperative physical activity on the rate of resumption of QoL and normal physical function.

Physical Activity Breast Neoplasm Colorectal Neoplasm Gall Stones

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Physical Activity on the Outcome of Surgery

Resource links provided by NLM:

Further study details as provided by Eva Angenete, Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Length of sick-leave/time to work [ Time Frame: 6 weeks ]
    for breast cancer and gallbladder surgery

  • Length of hospital stay [ Time Frame: 6 weekw ]
    for colorectal surgery

Secondary Outcome Measures:
  • length of sick leave/time to work [ Time Frame: 12 weeks ]
    for colon and rectal cancer: length of sick leave/time to work

  • length of hospital stay [ Time Frame: 6 weeks ]
    cholecystectomy and breast cancer: length of hospital stay

  • Recovery [ Time Frame: 6 weeks ]
    Recovery measured as resumption of Quality of Life and return to normal function after surgery according to the patient's self-reported assessment in the postoperative questionnaire and measured as return to pre-operative levels.

  • Health economic analysis [ Time Frame: 12 months ]
    Health economic analysis of resource consumption

Enrollment: 450
Study Start Date: December 2012
Study Completion Date: November 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Surgical patients
Patients with planned surgery for breast cancer, colorectal cancer and gall bladder disease

  Show Detailed Description


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients planned for a surgical procedure with a planned hospital stay of at least 1 day.

Inclusion Criteria:

  • All patients at including hospitals scheduled for any of the following procedures will be asked to participate: cholecystectomy, breast cancer surgery, colorectal cancer surgery

Exclusion Criteria:

  • Inability to give informed consent.
  Contacts and Locations
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): NCT01707121

Sahlgrenska University Hospital/Östra
Göteborg, Sweden, 416 85
Skövde Kärnsjukhus
Skövde, Sweden
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Principal Investigator: Eva Angenete, M.D., Ph.D. SSORG, Scandinavian Surgical Outcomes Research Group
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eva Angenete, Consultant surgeon, M.D., Ph.D., Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01707121     History of Changes
Other Study ID Numbers: Physsurg
First Submitted: October 11, 2012
First Posted: October 16, 2012
Last Update Posted: November 20, 2015
Last Verified: November 2015

Keywords provided by Eva Angenete, Sahlgrenska University Hospital, Sweden:
hospital stay

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Biliary Tract Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical