The Impact of Physical Activity on the Outcome of Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Sahlgrenska University Hospital, Sweden
Sponsor:
Information provided by (Responsible Party):
Eva Angenete, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01707121
First received: October 11, 2012
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition
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 Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Length of sick-leave/time to work [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    for breast cancer and gallbladder surgery

  • Length of hospital stay [ Time Frame: 6 weekw ] [ Designated as safety issue: No ]
    for colorectal surgery


Secondary Outcome Measures:
  • length of sick leave/time to work [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    for colon and rectal cancer: length of sick leave/time to work

  • length of hospital stay [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    cholecystectomy and breast cancer: length of hospital stay

  • Recovery [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Health economic analysis of resource consumption


Estimated Enrollment: 570
Study Start Date: December 2012
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgical patients
Patients with planned surgery for breast cancer, colorectal cancer and gall bladder disease

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707121

Contacts
Contact: Eva Angenete, M.D, Ph.D. 46313438410 eva.angenete@vgregion.se
Contact: Ingrid Höglund-Karlsson, R.N. B.Sc. ingrid.hoglund-karlsson@vgregion.se

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

Additional Information:
No publications provided

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
Study First Received: October 11, 2012
Last Updated: December 12, 2013
Health Authority: Sweden: Institutional Review Board

Keywords provided by Sahlgrenska University Hospital, Sweden:
morbidity
sick-leave
hospital stay

Additional relevant MeSH terms:
Neoplasms
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

ClinicalTrials.gov processed this record on September 18, 2014