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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010489
• Other study ID #: H2013:388
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre for Metabolic and Bariatric Surgery, Victoria General Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minute Walk Test (6MWT)	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.	Pre-Intervention
Primary	6 Minute Walk Test		Post Intervention (12 weeks)
Primary	6 Minute Walk Test		Post Operative (3 months)
Primary	6 Minute Walk Test		Post Operative (6 months)
Secondary	Anthropometric Measurements	Includes: Height (SECA 242 Electronic stadiometer); Weight (SECA 645 Multifunctional handrail scale); BMI (kg/m2); Neck circumference; Waist and hip circumference	Pre-Intervention
Secondary	Anthropometric Measurements	Includes: Height (SECA 242 Electronic stadiometer); Weight (SECA 645 Multifunctional handrail scale); BMI (kg/m2); Neck circumference; Waist and hip circumference	Post Intervention (12 weeks)
Secondary	Anthropometric Measurements	Includes: Height (SECA 242 Electronic stadiometer); Weight (SECA 645 Multifunctional handrail scale); BMI (kg/m2); Neck circumference; Waist and hip circumference	Post Operative (3 months)
Secondary	Anthropometric Measurements	Includes: Height (SECA 242 Electronic stadiometer); Weight (SECA 645 Multifunctional handrail scale); BMI (kg/m2); Neck circumference; Waist and hip circumference	Post Operative (6 months)
Secondary	Body Composition	Measured using Dual-energy X-ray Absorptiometry	Pre-Intervention
Secondary	Body Composition	Measured using Dual-energy X-ray Absorptiometry	Post Operative (6 months)
Secondary	Strength Measures	Includes; Chair to stand test; Half squat test; Hand grip test	Pre-Intervention
Secondary	Strength Measures	Includes; Chair to stand test; Half squat test; Hand grip test	Post Intervention (12 weeks)
Secondary	Strength Measures	Includes; Chair to stand test; Half squat test; Hand grip test	Post Operative (3 months)
Secondary	Strength Measures	Includes; Chair to stand test; Half squat test; Hand grip test	Post Operative (6 months)
Secondary	Other Measures	Includes: Accelerometer Physical Activity Level (Actigraph: Pensacola, FL); Laval Health Related Quality of Life Questionnaire; Satisfaction Survey	Pre-Intervention
Secondary	Other Measures	Includes: Accelerometer Physical Activity Level (Actigraph: Pensacola, FL); Laval Health Related Quality of Life Questionnaire; Satisfaction Survey	Post Intervention (12 weeks)
Secondary	Other Measures	Includes: Accelerometer Physical Activity Level (Actigraph: Pensacola, FL); Laval Health Related Quality of Life Questionnaire; Satisfaction Survey	Post Operative (3 months)
Secondary	Other Measures	Includes: Accelerometer Physical Activity Level (Actigraph: Pensacola, FL); Laval Health Related Quality of Life Questionnaire; Satisfaction Survey	Post Operative (6 months)
Secondary	Physical Activity Level	Measured using accelerometers	Pre-Intervention
Secondary	Physical Activity Level	Measured using accelerometers	Mid Intervention (6 weeks)
Secondary	Physical Activity Level	Measured using accelerometers	Post Operative (6 months)
Secondary	Irisin bloodwork	Irisin is a recently discovered peptide secreted by the skeletal muscle. It has been proposed that this novel peptide is secreted by muscle in response to exercise training and trigger cross talk between skeletal muscle and other organs. In fact, the beneficial effects of irisin would be elicited through an up-regulation of energy consumption within adipocytes, which results in glucose tolerance improvement and increase in endurance performance. Until now, one study investigated the predictor of changes in irisin following a bariatric surgery. However, no study has yet investigated whether a pre-surgery physical activity program contributes to the change in irisin level in severely obese patients.	At study enrollment/pre-intervention
Secondary	Irisin bloodwork		Post intervention/Pre-Surgery
Secondary	Irisin Bloodwork		Post operative (while in hospital)
Secondary	Irisin Bloodwork		Post operative (3 months)
Secondary	Irisin Bloodwork		Post Operative (6 months)
Secondary	Muscle Biopsy (optional)		Intra operative