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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01778153
Other study ID # Equinox Study
Secondary ID
Status Completed
Phase N/A
First received December 16, 2011
Last updated November 23, 2016
Start date January 2012
Est. completion date December 2012

Study information

Verified date November 2016
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 30 Years to 44 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Equinox Personal Coaching
Specially designed strength and aerobic exercise training program that consists of 36 sessions over 12 weeks.

Locations

Country Name City State
United States UCLA David Geffen School of Medicine Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles Equinox Fitness Centers

Country where clinical trial is conducted

United States, 

References & Publications (1)

Storer TW, Dolezal BA, Berenc MN, Timmins JE, Cooper CB. Effect of supervised, periodized exercise training vs. self-directed training on lean body mass and other fitness variables in health club members. J Strength Cond Res. 2014 Jul;28(7):1995-2006. doi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in lean body mass Change in lean body mass (LBM) as measured by dual-energy x-ray absorptiometry (DEXA) Baseline and 4 months No
Secondary Change in muscle strength 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 No
Secondary Change in aerobic performance Aerobic performance as assessed using a symptom-limited, treadmill ramp protocol. Baseline and 4 months No
Secondary Changes in ventilation and respiratory gas exchange 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 No
Secondary Change in quality of life A quality of life scale will also used to determine participant's satisfaction with their training and its result. Baseline and 4 months No
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