Clinical trial NCT02010489: The Impact of a Pre-Operative Exercise Program on Fitness Outcomes Following Bariatric Surgery
Official title: The Impact of a Pre-Operative Exercise Program on Fitness Outcomes Following Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Bariatric Surgery
Exercise
Physical Fitness
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 6 Minute Walk Test (6MWT)
timeFrame: Pre-Intervention
measure: 6 Minute Walk Test
timeFrame: Post Intervention (12 weeks)
measure: 6 Minute Walk Test
timeFrame: Post Operative (3 months)
measure: 6 Minute Walk Test
timeFrame: Post Operative (6 months)
Secondary outcomes:
measure: Anthropometric Measurements
timeFrame: Pre-Intervention
measure: Anthropometric Measurements
timeFrame: Post Intervention (12 weeks)
measure: Anthropometric Measurements
timeFrame: Post Operative (3 months)
measure: Anthropometric Measurements
timeFrame: Post Operative (6 months)
measure: Body Composition
timeFrame: Pre-Intervention
measure: Body Composition
timeFrame: Post Operative (6 months)
measure: Strength Measures
timeFrame: Pre-Intervention
measure: Strength Measures
timeFrame: Post Intervention (12 weeks)
measure: Strength Measures
timeFrame: Post Operative (3 months)
measure: Strength Measures
timeFrame: Post Operative (6 months)
measure: Other Measures
timeFrame: Pre-Intervention
measure: Other Measures
timeFrame: Post Intervention (12 weeks)
measure: Other Measures
timeFrame: Post Operative (3 months)
measure: Other Measures
timeFrame: Post Operative (6 months)
measure: Physical Activity Level
timeFrame: Pre-Intervention
measure: Physical Activity Level
timeFrame: Mid Intervention (6 weeks)
measure: Physical Activity Level
timeFrame: Post Operative (6 months)
measure: Irisin bloodwork
timeFrame: At study enrollment/pre-intervention
measure: Irisin bloodwork
timeFrame: Post intervention/Pre-Surgery
measure: Irisin Bloodwork
timeFrame: Post operative (while in hospital)
measure: Irisin Bloodwork
timeFrame: Post operative (3 months)
measure: Irisin Bloodwork
timeFrame: Post Operative (6 months)
measure: Muscle Biopsy (optional)
timeFrame: Intra operative
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Centre for Metabolic and Bariatric Surgery, Victoria General Hospital
state: Manitoba
Study officials:
affiliation: Assistant Professor, University of Manitoba
name: Krista Hardy, MD
role: PRINCIPAL_INVESTIGATOR
References: