- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04680455
Strength Training for Men Living With Obesity
Potential Benefits of Strength Training for Men Living With Obesity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sixty men (age ≥ 18 years; body fat % ≥ 25) were randomly assigned to the intervention group (N=30) or the control condition (N=30) for 12 weeks. The intervention group did the online delivered circuit training, three sessions in a week. Adherence to the weekly physical activity guidelines was evaluated 46 weeks after being enrolled in the program using a heart rate tracker and an exercise log. Most variables (anthropometrics, body composition, resting heart rate, blood pressure, lipids profile, glucose) were measured at baseline and after 12, 24, and 46 weeks. Aerobic fitness and comfort with technology were measured at baseline. Perceived benefits/barriers of participation in exercise were captured at baseline and 12 weeks.
More participants in the intervention group adhered to the physical activity guidelines compared to the control group at 46 weeks (intervention 36.8% vs control 5.3%; p=0.021). However, the intervention group did not improve their health outcomes after 12, 24, and 46 weeks. Fewer barriers were reported after 12-week for the intervention group (p=0.02).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Brunswick
-
Fredericton, New Brunswick, Canada, E3B 5A3
- University of New Brunswick
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- men
- Body fat% of 25% or more
- Not reaching physical activity guidelines (150 min of moderate to vigorous intensity of aerobic exercises + two sessions of resistance training)
- being able to do weight training
Exclusion Criteria:
- Taking medications that can cause to change in heart rate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Participants in the intervention group were asked to exercise three times per week while performing four basic bodyweight exercises in a circuit manner for 12 weeks while supervised online via the Microsoft TEAMs platform.
Participants were eased into the program by completing 120 minutes of exercise in week one, 150 minutes in week two, and 180 minutes in the following weeks.
Participants were supervised 3X/week for the first four weeks, then 2X/week for the next four weeks and 1X/week for the remaining four weeks.
At each session, participants performed the four prescribed exercises (squats, tricep dips, lunges, and push-ups) for 45 seconds each, then switched immediately (15 seconds) to the next exercise followed by one minute of rest at the end of each circuit.
Following this exercise program, men living with obesity were able to reach moderate intensity.
|
Body weight exercises (i.e., squats, tricep dips, lunges, and push-ups) delivered online through Teams
|
|
No Intervention: Control
Participants allocated to the control group received an online exercise resource for a 12-week workout plan covering fitness components required to reach both components of the weekly physical activity guidelines on their own.
It was recommended that they do a minimum of 150 minutes of moderate to vigorous aerobic activities and two sessions of muscle-strengthening activities using an online program.
No supervision was offered and no contact was permitted between the research team and participants from this group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity Level
Time Frame: 48 weeks
|
Adherence to the both components of the physical activity guidelines
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiorespiratory fitness
Time Frame: Baseline
|
Maximum volume of oxygen consumption (Vo2peak)
|
Baseline
|
|
BMI
Time Frame: 46 weeks
|
Anthropometrics
|
46 weeks
|
|
Waist circumference
Time Frame: 46 weeks
|
Anthropometrics
|
46 weeks
|
|
Body fat percentage
Time Frame: 46 weeks
|
Body composition
|
46 weeks
|
|
Muscle mass
Time Frame: 46 weeks
|
Body composition
|
46 weeks
|
|
Metabolic profile
Time Frame: 46 weeks
|
High density lipoprotein, low density lipoprotein, triglyceride, resting heart rate, blood pressure
|
46 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNew Brunswick
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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