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Completed

NCT Number: NCT02010489

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.

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Metabolic and Bariatric Surgery, Victoria General Hospital

Winnipeg, Manitoba, R3T 2E8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

12 week Exercise Program

Other

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.

Primary outcomes

  1. 6 Minute Walk Test (6MWT)

    Time frame: 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.

  2. 6 Minute Walk Test

    Time frame: Post Intervention (12 weeks)

  3. 6 Minute Walk Test

    Time frame: Post Operative (3 months)

  4. 6 Minute Walk Test

    Time frame: Post Operative (6 months)

Secondary outcomes

  1. Anthropometric Measurements

    Time frame: Pre-Intervention

    Includes:

    • Height (SECA 242 Electronic stadiometer)
    • Weight (SECA 645 Multifunctional handrail scale)
    • BMI (kg/m2)
    • Neck circumference
    • Waist and hip circumference

  2. Anthropometric Measurements

    Time frame: Post Intervention (12 weeks)

    Includes:

    • Height (SECA 242 Electronic stadiometer)
    • Weight (SECA 645 Multifunctional handrail scale)
    • BMI (kg/m2)
    • Neck circumference
    • Waist and hip circumference

  3. Anthropometric Measurements

    Time frame: Post Operative (3 months)

    Includes:

    • Height (SECA 242 Electronic stadiometer)
    • Weight (SECA 645 Multifunctional handrail scale)
    • BMI (kg/m2)
    • Neck circumference
    • Waist and hip circumference

  4. Anthropometric Measurements

    Time frame: Post Operative (6 months)

    Includes:

    • Height (SECA 242 Electronic stadiometer)
    • Weight (SECA 645 Multifunctional handrail scale)
    • BMI (kg/m2)
    • Neck circumference
    • Waist and hip circumference

  5. Body Composition

    Time frame: Pre-Intervention

    Measured using Dual-energy X-ray Absorptiometry

  6. Body Composition

    Time frame: Post Operative (6 months)

    Measured using Dual-energy X-ray Absorptiometry

  7. Strength Measures

    Time frame: Pre-Intervention

    Includes

    • Chair to stand test
    • Half squat test
    • Hand grip test

  8. Strength Measures

    Time frame: Post Intervention (12 weeks)

    Includes

    • Chair to stand test
    • Half squat test
    • Hand grip test

  9. Strength Measures

    Time frame: Post Operative (3 months)

    Includes

    • Chair to stand test
    • Half squat test
    • Hand grip test

  10. Strength Measures

    Time frame: Post Operative (6 months)

    Includes

    • Chair to stand test
    • Half squat test
    • Hand grip test

  11. Other Measures

    Time frame: Pre-Intervention

    Includes:

    • Accelerometer Physical Activity Level (Actigraph: Pensacola, FL)
    • Laval Health Related Quality of Life Questionnaire
    • Satisfaction Survey

  12. Other Measures

    Time frame: Post Intervention (12 weeks)

    Includes:

    • Accelerometer Physical Activity Level (Actigraph: Pensacola, FL)
    • Laval Health Related Quality of Life Questionnaire
    • Satisfaction Survey

  13. Other Measures

    Time frame: Post Operative (3 months)

    Includes:

    • Accelerometer Physical Activity Level (Actigraph: Pensacola, FL)
    • Laval Health Related Quality of Life Questionnaire
    • Satisfaction Survey

  14. Other Measures

    Time frame: Post Operative (6 months)

    Includes:

    • Accelerometer Physical Activity Level (Actigraph: Pensacola, FL)
    • Laval Health Related Quality of Life Questionnaire
    • Satisfaction Survey

  15. Physical Activity Level

    Time frame: Pre-Intervention

    Measured using accelerometers

  16. Physical Activity Level

    Time frame: Mid Intervention (6 weeks)

    Measured using accelerometers

  17. Physical Activity Level

    Time frame: Post Operative (6 months)

    Measured using accelerometers

  18. Irisin bloodwork

    Time frame: At study enrollment/pre-intervention

    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.

  19. Irisin bloodwork

    Time frame: Post intervention/Pre-Surgery

  20. Irisin Bloodwork

    Time frame: Post operative (while in hospital)

  21. Irisin Bloodwork

    Time frame: Post operative (3 months)

  22. Irisin Bloodwork

    Time frame: Post Operative (6 months)

  23. Muscle Biopsy (optional)

    Time frame: Intra operative

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 12, 2013
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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