The Impact of a Pre-Operative Exercise Program on Fitness Outcomes Following Bariatric Surgery

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT02010489
• Lead Sponsor: University of Manitoba

Brief Summary

BACKGROUND: Obesity is a global epidemic and Canada has one of the highest obesity rates in westernized countries. Obesity has many health related complications, including high blood pressure, high cholesterol, diabetes, sleep apnea and osteoarthritis. Bariatric surgery is the most effective way of achieving long-term weight loss and treating the complications of obesity. There is good evidence to support the relationship between physical activity and weight loss following bariatric surgery. While the period leading up to surgery is considered an important opportunity for lifestyle modification, evidence to support recommendations for a supervised preoperative exercise intervention is lacking.

OBJECTIVES: The objective of this study is to measure the short and intermediate-term benefits of a preoperative exercise intervention on patients awaiting publicly funded bariatric surgery in Manitoba. The primary outcome will be improvement in general exercise capacity as measured by change in 6-minute walk test (how far a person can walk on a flat surface in 6 minutes). Other outcomes will include excess weight loss, change in body composition, strength testing and irisin bloodwork \& muscle biopsy.

HYPOTHESIS: It is hypothesized that preoperative exercise will result in improved exercise capacity and general fitness in the short and intermediate-term post-bariatric surgery.

METHODS: Patients who are awaiting publicly funded bariatric surgery in Manitoba will be offered the opportunity to participate in a randomized study between usual preoperative care (n=35) and usual care plus a supervised exercise program (n=35). Usual care will involve multidisciplinary evaluation and preoperative counseling with a kinesiologist. In the intervention group, patients will participate in a 12-week supervised exercise program at the Reh-fit Centre.

RESULTS: The study will determine the short and intermediate-term benefits of a preoperative exercise intervention on general fitness and exercise capacity as well as weight loss post-bariatric surgery. It is an important opportunity for collaboration between a multidisciplinary health care team and a medically-certified community fitness centre. Currently there are approximately 200 patients undergoing public bariatric surgery annually in Manitoba. If this study demonstrates a benefit to preoperative exercise, the results will be used to support an application to Manitoba Health for routine implementation of a similar intervention for all patients awaiting publicly funded bariatric surgery. It will also be used to support an application for a larger multi-institutional study of preoperative exercise at several Canadian bariatric centres.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-12
• Study Start: 2014-07-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Adult patients, 18 years or older
• Awaiting publicly funded bariatric surgery through the Centre for Metabolic and Bariatric Surgery
• Must be undergoing surgery within six months of tentative approval (usual timeline)
• Must be able to participate in an exercise program at the Reh-Fit Centre in Winnipeg. There will be a home option for some of the activities but patients will be expected to attend at least one of three sessions at the Reh-Fit Centre weekly

Exclusion Criteria

• Orthopedic, neurologic or cardiopulmonary conditions that preclude moderately strenuous exercise
• In general, patients are not considered candidates for bariatric surgery if they are wheelchair bound or cannot tolerate moderate physical activity.
• Patients will also be excluded if they are unable to commit to attending regular sessions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
6 Minute Walk Test (6MWT)	Pre-Intervention	The 6MWT is a validated measure of physical fitness (22) and involves measuring the distance a patient walks unassisted in six minutes at a self-selected pace.
6 Minute Walk Test	Post Operative (6 months)

Secondary Outcome Measures

Name	Time	Method
Anthropometric Measurements	Post Operative (6 months)	Includes: 1. Height (SECA 242 Electronic stadiometer); 2. Weight (SECA 645 Multifunctional handrail scale); 3. BMI (kg/m2); 4. Neck circumference; 5. Waist and hip circumference
Body Composition	Post Operative (6 months)	Measured using Dual-energy X-ray Absorptiometry
Strength Measures	Post Operative (6 months)	Includes; 1. Chair to stand test; 2. Half squat test; 3. Hand grip test
Other Measures	Post Operative (6 months)	Includes: 1. Accelerometer Physical Activity Level (Actigraph: Pensacola, FL); 2. Laval Health Related Quality of Life Questionnaire; 3. Satisfaction Survey
Physical Activity Level	Post Operative (6 months)	Measured using accelerometers
Irisin bloodwork	Post intervention/Pre-Surgery
Irisin Bloodwork	Post Operative (6 months)
Muscle Biopsy (optional)	Intra operative

Trial Locations

Locations (1)

Centre for Metabolic and Bariatric Surgery, Victoria General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada