- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01778153
Equinox Personal Coaching Versus Self-Directed Exercise
Effectiveness of Equinox Fitness Club's Personal Coaching Method Versus Self-Directed Exercise Training on Increasing Lean Body Mass in Men Aged 30-44 Years of Age
The purpose of this study is to compare the Equinox Personal Coaching exercise training method to self-directed exercise training in helping subjects become more fit. Men between 30 and 44 years of age who exercise on a regular basis and are interested in receiving Equinox personal training will be invited to participate. The investigators will enroll 36 subjects at University of California, Los Angeles (UCLA), the only site. The hypothesis of this study is that subjects randomized to the Personal Coaching Method will result in significantly greater lean mass accrual than those randomized to self-directed training over the 12 weeks of the study.
Subjects will have 2 Baseline visits over 1 week, then be randomized to receive either Coached training or self-training, which they will do for 12 weeks, then complete two End of Study visits over the final week. Visits 1 and 3 include questionnaires, skinfold fat/lean body mass measurements, and strength and aerobic performance tests, and will take place at Equinox. Visits 2 and 4 include a DEXA scan and ECG, which will take place at UCLA.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA David Geffen School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men aged 30-44 years
- Body mass index less than 30 kg/m2.
- Currently exercising with or without coaching more than 4 days but less than 8 days per month for the past three months (Equinox Motivated or Super Motivated categories);
- Willing to commit to 12 weeks of thrice weekly training at the Century City Equinox club with or without an Equinox coach.
Exclusion Criteria:
- Over age 44
- Musculoskeletal conditions limiting participation
- Unstable cardiovascular, pulmonary, metabolic, or other disorders that would preclude high intensity exercise training.
- Abnormal ECG at Screening that indicates the subject is not healthy enough for maximal exercise in the opinion of the principal investigator
- Family history of sudden death associated with exercise, based on self-report
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: Equinox Personal Coaching
Participants assigned the Coached group will receive up to 36 sessions about three times a week, consisting of both strength and aerobic exercises, through a program designed by Equinox Fitness Centers.
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Specially designed strength and aerobic exercise training program that consists of 36 sessions over 12 weeks.
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|
No Intervention: Self-directed exercise training
Participants in the Self-directed group will receive general exercise training advice as any member of the fitness club would, and will record the details of their exercise in log sheets.
They will be asked to continue their usual exercise routine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in lean body mass
Time Frame: Baseline and 4 months
|
Change in lean body mass (LBM) as measured by dual-energy x-ray absorptiometry (DEXA)
|
Baseline and 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in muscle strength
Time Frame: Baseline and 4 months
|
Changes in muscle strength in the upper and lower extremities as assessed with standard one-repetition maximum tests for the chest press and leg press exercises, respectively
|
Baseline and 4 months
|
|
Change in aerobic performance
Time Frame: Baseline and 4 months
|
Aerobic performance as assessed using a symptom-limited, treadmill ramp protocol.
|
Baseline and 4 months
|
|
Changes in ventilation and respiratory gas exchange
Time Frame: Baseline and 4 months
|
Measures of ventilation and respiratory gas exchange including changes in maximum oxygen uptake, the metabolic (lactate) threshold, and other parameters of aerobic, cardiovascular, and ventilatory fitness.
|
Baseline and 4 months
|
|
Change in quality of life
Time Frame: Baseline and 4 months
|
A quality of life scale will also used to determine participant's satisfaction with their training and its result.
|
Baseline and 4 months
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Equinox Study
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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