NCT01778153

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

December 16, 2011

Last Update Submit

November 23, 2016

Conditions

Keywords

Fitness trainingPersonal training

Outcome Measures

Primary Outcomes (1)

  • Change in lean body mass

    Change in lean body mass (LBM) as measured by dual-energy x-ray absorptiometry (DEXA)

    Baseline and 4 months

Secondary Outcomes (4)

  • Change in muscle strength

    Baseline and 4 months

  • Change in aerobic performance

    Baseline and 4 months

  • Changes in ventilation and respiratory gas exchange

    Baseline and 4 months

  • Change in quality of life

    Baseline and 4 months

Study Arms (2)

Equinox Personal Coaching

EXPERIMENTAL

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.

Behavioral: Equinox Personal Coaching

Self-directed exercise training

NO INTERVENTION

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.

Interventions

Specially designed strength and aerobic exercise training program that consists of 36 sessions over 12 weeks.

Equinox Personal Coaching

Eligibility Criteria

Age30 Years - 44 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

Related 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: 10.1519/JSC.0000000000000331.

Study Officials

  • Christopher B Cooper, M.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2011

First Posted

January 29, 2013

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations