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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: 12 week Exercise Program

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 2E8
      • Centre for Metabolic and Bariatric Surgery, Victoria General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Following randomization, the control group will receive usual preoperative care consisting of two to four multidisciplinary visits over six months. During this time, patients will be provided with exercise counseling through the team kinesiologist. They will complete a behavior modification program called Craving ChangeTM and must achieve usual goals of lifestyle and dietary modification, along with modest weight loss of approximately 5%, in order to be scheduled for surgery. Patients will also complete a liquid diet consisting of 900 calories per day for two weeks prior to their procedure in order to reduce intra-abdominal obesity and facilitate the procedure.
Other: 12 Week Exercise Program; The intervention group will undergo standard pre-operative care and will also be enrolled in a 12-week exercise program at the Reh-Fit Centre in Winnipeg. The Reh-Fit Centre is a non-profit organization with the mission to enhance the health and wellbeing of its members and the community by providing innovative health and fitness services. The intervention will be offered at no cost to the patient. It will involve regular supervised exercise sessions at the Reh-fit centre three times per week. Most patients will complete the intervention prior to commencing the liquid diet but will otherwise discontinue the program while on the diet two weeks prior to surgery.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
6 Minute Walk Test		Post Intervention (12 weeks)
6 Minute Walk Test		Post Operative (3 months)
6 Minute Walk Test		Post Operative (6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)
Body Composition	Measured using Dual-energy X-ray Absorptiometry	Pre-Intervention
Body Composition	Measured using Dual-energy X-ray Absorptiometry	Post Operative (6 months)
Strength Measures	Includes; Chair to stand test; Half squat test; Hand grip test	Pre-Intervention
Strength Measures	Includes; Chair to stand test; Half squat test; Hand grip test	Post Intervention (12 weeks)
Strength Measures	Includes; Chair to stand test; Half squat test; Hand grip test	Post Operative (3 months)
Strength Measures	Includes; Chair to stand test; Half squat test; Hand grip test	Post Operative (6 months)
Other Measures	Includes: Accelerometer Physical Activity Level (Actigraph: Pensacola, FL); Laval Health Related Quality of Life Questionnaire; Satisfaction Survey	Pre-Intervention
Other Measures	Includes: Accelerometer Physical Activity Level (Actigraph: Pensacola, FL); Laval Health Related Quality of Life Questionnaire; Satisfaction Survey	Post Intervention (12 weeks)
Other Measures	Includes: Accelerometer Physical Activity Level (Actigraph: Pensacola, FL); Laval Health Related Quality of Life Questionnaire; Satisfaction Survey	Post Operative (3 months)
Other Measures	Includes: Accelerometer Physical Activity Level (Actigraph: Pensacola, FL); Laval Health Related Quality of Life Questionnaire; Satisfaction Survey	Post Operative (6 months)
Physical Activity Level	Measured using accelerometers	Pre-Intervention
Physical Activity Level	Measured using accelerometers	Mid Intervention (6 weeks)
Physical Activity Level	Measured using accelerometers	Post Operative (6 months)
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
Irisin bloodwork		Post intervention/Pre-Surgery
Irisin Bloodwork		Post operative (while in hospital)
Irisin Bloodwork		Post operative (3 months)
Irisin Bloodwork		Post Operative (6 months)
Muscle Biopsy (optional)		Intra operative

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Krista Hardy, MD, Assistant Professor, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 12, 2013

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Bariatric Surgery; Physical Fitness
• Other Study ID Numbers: H2013:388