Resistance Training for Men Living With Obesity

Sponsor

University of New Brunswick (Other)

Overall Status

Recruiting

CT.gov ID

NCT04680455

Collaborator

(none)

Enrollment

Location

Arms

16.3

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Emerging evidences suggest that alternative obesity management strategies need to address gender preferences to adopt healthier lifestyles such as resistance training. It is hypothesized that more men living with obesity who will be exposed to a novel resistance circuit training program (RT+) for 12 weeks will more physically active, 48 weeks after the intervention compare with people who will not exposed to RT+ program.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Resistance Training + (RT+)	N/A

Detailed Description

Sixty men living with obesity will be recruited and randomly assigned to either a standard care group (N = 30) or an intervention group (N = 30). Eligible participants will be age 19 years or older, living with obesity (BF ≥ 28%), able to perform exercises, but not currently engaged in regular physical activities (150 min of moderate to vigorous aerobic activities + two sessions of RT per week). Participants will be asked to maintain their current dietary habits within the duration of the project.

Sample size calculations was done based on the anticipated change in the proportion of obese men to achieve the PA guidelines (minimum of 150 minutes spent at MVPA in a week in addition to two sessions of RT). It is predicted that the proportion of men living with obesity who meet physical activity guidelines (both aerobic MVPA and RT) in the RT+ group will increase to 26.2% (similar to lean counterparts) at follow-up compared with 0% increased for the control group. The alpha level and power of analysis were set at 0.05 and 80% respectively, considering a drop-out rate of 30% in each group. A total of 23 people per group were required, so investigators will recruit 30 per group.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Controlled TrialRandomized Controlled Trial

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Double-blind study

Primary Purpose:

Prevention

Official Title:

Resistance Training for Men Living With Obesity

Actual Study Start Date :

Sep 22, 2020

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Resistance Training + (RT+) Participants in RT+ group will be asked to exercise three times per week and perform four basic RT exercises in a circuit manner for 12 weeks while supervised via an online platform such as Skype or TEAM. The first four weeks of sessions will be fully supervised. Participants will be eased into the program using a three-week progressive start, completing 120 minutes of exercise in week one, 150 minutes in week two, 180 minutes in week three and week four. Participants will be 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, a participant will perform the four prescribed exercises (i.e., squats, tricep dips, lunges, and push-ups) for 45 seconds each, then switch immediately (15 seconds) to the next exercise followed by one-minute of rest at the end of each circuit. The circuit will repeat until the session is complete.	Other: Resistance Training + (RT+) Body weight exercises (i.e., squats, tricep dips, lunges, and push-ups)
No Intervention: Standard care Participants allocated to the control standard care group will receive free access to an exercise platform (V-Shred-Ripped-in-90-days) for the same period of time (12 weeks) to become more active. It will be recommended that they do a minimum of 150 minutes of moderate to vigorous aerobic activities and two resistance training sessions using the platform.

Arm

Intervention/Treatment

Experimental: Resistance Training + (RT+)

Participants in RT+ group will be asked to exercise three times per week and perform four basic RT exercises in a circuit manner for 12 weeks while supervised via an online platform such as Skype or TEAM. The first four weeks of sessions will be fully supervised. Participants will be eased into the program using a three-week progressive start, completing 120 minutes of exercise in week one, 150 minutes in week two, 180 minutes in week three and week four. Participants will be 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, a participant will perform the four prescribed exercises (i.e., squats, tricep dips, lunges, and push-ups) for 45 seconds each, then switch immediately (15 seconds) to the next exercise followed by one-minute of rest at the end of each circuit. The circuit will repeat until the session is complete.

Other: Resistance Training + (RT+)

Body weight exercises (i.e., squats, tricep dips, lunges, and push-ups)

No Intervention: Standard care

Participants allocated to the control standard care group will receive free access to an exercise platform (V-Shred-Ripped-in-90-days) for the same period of time (12 weeks) to become more active. It will be recommended that they do a minimum of 150 minutes of moderate to vigorous aerobic activities and two resistance training sessions using the platform.

Outcome Measures

Primary Outcome Measures

Physical activity Level [48 weeks]
Adherence to the Canadian Physical Activity Guideline

Secondary Outcome Measures

HDL [48 weeks]
Lipid profile- Hight Density Lipoprotein
Cardiorespiratory Fitness [48 weeks]
Maximum volume of oxygen consumption (Vo2peak)
LDL [48 weeks]
Lipid profile- Low Density Lipoprotein
TC [48 weeks]
Lipid profile- Total Cholesterol
TG [48 weeks]
Lipid profile- Triglyceride
Glucose [48 weeks]
Fasting Blood glucose
Weight [48 weeks]
Anthropometrics
Waist Circumference [48 week]
Anthropometrics
Body Fat Percentage [48 weeks]
Anthropometrics
Height [48 weeks]
Anthropometrics
Body Fat Free Percentage [48 weeks]
Anthropometrics

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

male
living with obesity
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 heart rate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of New Brunswick	Fredericton	New Brunswick	Canada	E3B 5A3

Sponsors and Collaborators

University of New Brunswick

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol - Sep 22, 2020

More Information

Publications

None provided.

Responsible Party:

University of New Brunswick

ClinicalTrials.gov Identifier:

NCT04680455

Other Study ID Numbers:

UNew Brunswick

First Posted:

Dec 23, 2020

Last Update Posted:

Nov 22, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of New Brunswick

Physical Activity

Chronic Conditions

Strength Training

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Nov 22, 2021