The Impact of Physical Activity on the Outcome of Surgery
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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 |
- 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
- 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: | December 2013 (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 |
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| 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 |
| Sweden | |
| Sahlgrenska University Hospital/Östra | Recruiting |
| Göteborg, Sweden, 416 85 | |
| Principal Investigator: Eva Angenete, M.D., Ph.D. | |
| Skövde Kärnsjukhus | Recruiting |
| Skövde, Sweden | |
| 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: | April 15, 2013 |
| Health Authority: | Sweden: Institutional Review Board |
Keywords provided by Sahlgrenska University Hospital, Sweden:
|
morbidity sick-leave hospital stay |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Gallstones Cholelithiasis Cholecystolithiasis Colorectal Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Biliary Tract Diseases Digestive System Diseases |
Gallbladder Diseases Calculi Pathological Conditions, Anatomical Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013