NCT01707121

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

2.8 years

First QC Date

October 11, 2012

Last Update Submit

November 18, 2015

Conditions

Physical ActivityBreast NeoplasmColorectal NeoplasmGall Stones

Keywords

morbiditysick-leavehospital stay

Outcome Measures

Primary Outcomes (2)

  • Length of sick-leave/time to work

    for breast cancer and gallbladder surgery

    6 weeks

  • Length of hospital stay

    for colorectal surgery

    6 weekw

Secondary Outcomes (4)

  • length of sick leave/time to work

    12 weeks

  • length of hospital stay

    6 weeks

  • Recovery

    6 weeks

  • Health economic analysis

    12 months

Study Arms (1)

Surgical patients

Patients with planned surgery for breast cancer, colorectal cancer and gall bladder disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients planned for a surgical procedure with a planned hospital stay of at least 1 day.

You may qualify if:

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

You may not qualify if:

  • Inability to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sahlgrenska University Hospital/Östra

Gothenburg, 416 85, Sweden

Location

Skövde Kärnsjukhus

Skövde, Sweden

Location

Related Publications (1)

  • Nilsson H, Angeras U, Bock D, Borjesson M, Onerup A, Fagevik Olsen M, Gellerstedt M, Haglind E, Angenete E. Is preoperative physical activity related to post-surgery recovery? A cohort study of patients with breast cancer. BMJ Open. 2016 Jan 14;6(1):e007997. doi: 10.1136/bmjopen-2015-007997.

    PMID: 26769776DERIVED

MeSH Terms

Conditions

Motor ActivityBreast NeoplasmsColorectal NeoplasmsGallstones

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCholelithiasisBiliary Tract DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Eva Angenete, M.D., Ph.D.

    SSORG, Scandinavian Surgical Outcomes Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant surgeon, M.D., Ph.D.

Study Record Dates

First Submitted

October 11, 2012

First Posted

October 16, 2012

Study Start

December 1, 2012

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

SE(2)