Trials / Completed
CompletedNCT02010489
The Impact of a Pre-Operative Exercise Program on Fitness Outcomes Following Bariatric Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- University of Manitoba · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 12 week Exercise Program | Patients will be provided with a tour of the Reh-Fit Centre, exercise prescription, and supervised exercise session. The exercise prescription consists of 3 weekly 60-minute sessions, each with 10 minutes warm-up, 30 minutes endurance, 20 minutes strength training and 5 minutes cool-down. The program is overseen by an accredited Exercise Physiologist. Initial exercise intensity is determined by the kinesiologist and based on the patient's baseline fitness level. Goal intensity of endurance activity is based on the heart rate reserve (HRR) method. This is captured with a heart rate monitor at initial assessment and recorded on exercise logs. There are check-ins at each exercise session to determine progress (time, reps, weight, sets, etc). Endurance activities include treadmill, elliptical, walking, and aerobics. Strength training includes upper body, lower body, and trunk circuits. Patients will be asked to attend three weekly sessions at the Reh-Fit Centre. |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2018-12-31
- Completion
- 2018-12-31
- First posted
- 2013-12-12
- Last updated
- 2019-01-23
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02010489. Inclusion in this directory is not an endorsement.