ObesityNCT02010489
The Impact of a Pre-Operative Exercise Program on Fitness Outcomes Following Bariatric Surgery
A study testing 12 week Exercise Program in people with Obesity, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- 12 week Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2014to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Metabolic and Bariatric Surgery, Victoria General Hospital
Winnipeg, Manitoba, R3T 2E8
About this study
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.
Read more
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
- Obesity
- Being tested
- 12 week Exercise Program
- Keywords
- Bariatric Surgery, Exercise, Physical Fitness
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 week Exercise ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| 12 Week Exercise Program | Other | 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. Receives: Other: 12 week Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-Intervention
6 Minute Walk Test
Measured: Post Intervention (12 weeks)
6 Minute Walk Test
Measured: Post Operative (3 months)
6 Minute Walk Test
Measured: Post Operative (6 months)
Secondary outcomes (23)
Anthropometric Measurements
Includes:
- Height (SECA 242 Electronic stadiometer)
- Weight (SECA 645 Multifunctional handrail scale)
- BMI (kg/m2)
- Neck circumference
- Waist and hip circumference
Measured: 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
Measured: 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
Measured: 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
Measured: Post Operative (6 months)
Body Composition
Measured using Dual-energy X-ray Absorptiometry
Measured: Pre-Intervention
Body Composition
Measured using Dual-energy X-ray Absorptiometry
Measured: Post Operative (6 months)
Strength Measures
Includes
- Chair to stand test
- Half squat test
- Hand grip test
Measured: Pre-Intervention
Strength Measures
Includes
- Chair to stand test
- Half squat test
- Hand grip test
Measured: Post Intervention (12 weeks)
Strength Measures
Includes
- Chair to stand test
- Half squat test
- Hand grip test
Measured: Post Operative (3 months)
Strength Measures
Includes
- Chair to stand test
- Half squat test
- Hand grip test
Measured: Post Operative (6 months)
Other Measures
Includes:
- Accelerometer Physical Activity Level (Actigraph: Pensacola, FL)
- Laval Health Related Quality of Life Questionnaire
- Satisfaction Survey
Measured: Pre-Intervention
Other Measures
Includes:
- Accelerometer Physical Activity Level (Actigraph: Pensacola, FL)
- Laval Health Related Quality of Life Questionnaire
- Satisfaction Survey
Measured: Post Intervention (12 weeks)
Other Measures
Includes:
- Accelerometer Physical Activity Level (Actigraph: Pensacola, FL)
- Laval Health Related Quality of Life Questionnaire
- Satisfaction Survey
Measured: Post Operative (3 months)
Other Measures
Includes:
- Accelerometer Physical Activity Level (Actigraph: Pensacola, FL)
- Laval Health Related Quality of Life Questionnaire
- Satisfaction Survey
Measured: Post Operative (6 months)
Physical Activity Level
Measured using accelerometers
Measured: Pre-Intervention
Physical Activity Level
Measured using accelerometers
Measured: Mid Intervention (6 weeks)
Physical Activity Level
Measured using accelerometers
Measured: 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.
Measured: At study enrollment/pre-intervention
Irisin bloodwork
Measured: Post intervention/Pre-Surgery
Irisin Bloodwork
Measured: Post operative (while in hospital)
Irisin Bloodwork
Measured: Post operative (3 months)
Irisin Bloodwork
Measured: Post Operative (6 months)
Muscle Biopsy (optional)
Measured: Intra operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study start1 Jul 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krista Hardy, MD, Principal investigator, Assistant Professor, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010489
- Sponsor's protocol ID
- H2013:388
- Status last verified
- Jan 2019
- First submitted
- 9 Dec 2013
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Pre-Operative Exercise Program on Fitness Outcomes Following Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02010489
- Acronym / sponsor ID
- H2013:388
- Conditions
- Obesity
- Keywords
- Bariatric Surgery, Exercise, Physical Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| 12 Week Exercise Program | Other | Other: 12 week Exercise ProgramThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12 week Exercise ProgramPatients 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. | Other | 12 Week Exercise Program |
Primary outcome
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.
6 Minute Walk Test
Time frame: Post Intervention (12 weeks)
6 Minute Walk Test
Time frame: Post Operative (3 months)
6 Minute Walk Test
Time frame: Post Operative (6 months)
23 secondary outcomes
Anthropometric Measurements
Time frame: Pre-Intervention
Anthropometric Measurements
Time frame: Post Intervention (12 weeks)
Anthropometric Measurements
Time frame: Post Operative (3 months)
Anthropometric Measurements
Time frame: Post Operative (6 months)
Body Composition
Time frame: Pre-Intervention
Body Composition
Time frame: Post Operative (6 months)
Strength Measures
Time frame: Pre-Intervention
Strength Measures
Time frame: Post Intervention (12 weeks)
Strength Measures
Time frame: Post Operative (3 months)
Strength Measures
Time frame: Post Operative (6 months)
Other Measures
Time frame: Pre-Intervention
Other Measures
Time frame: Post Intervention (12 weeks)
Other Measures
Time frame: Post Operative (3 months)
Other Measures
Time frame: Post Operative (6 months)
Physical Activity Level
Time frame: Pre-Intervention
Physical Activity Level
Time frame: Mid Intervention (6 weeks)
Physical Activity Level
Time frame: Post Operative (6 months)
Irisin bloodwork
Time frame: At study enrollment/pre-intervention
Irisin bloodwork
Time frame: Post intervention/Pre-Surgery
Irisin Bloodwork
Time frame: Post operative (while in hospital)
Irisin Bloodwork
Time frame: Post operative (3 months)
Irisin Bloodwork
Time frame: Post Operative (6 months)
Muscle Biopsy (optional)
Time frame: Intra operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krista Hardy, MD principal investigator
Assistant Professor, University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 week Exercise Program in people with Obesity, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (6MWT) (time frame: Pre-Intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.