Efficacy of Exercise Videogames for Physical Activity Adoption and Maintenance

April 23, 2019 updated by: The Miriam Hospital
This is a 3-arm trial to compare exercise videogames versus traditional standard exercise using stationary bikes and treadmills versus a control condition. Results will examine minutes of physical activity at 12 weeks and 6 month follow up between conditions. We will also examine changes in indicators of cardiovascular health (e.g., body mass index, lipids) and changes in psychological factors that may be predictive of continued exercise engagement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To test the efficacy of a 12-week supervised, laboratory based program of an exercise videogame (EVG) program to increase time spent in moderate-to-vigorous physical activity (MVPA) and improve cardiovascular health and fitness indices compared to Standard and Control programs. Participants will be randomly assigned to (1) a supervised program of Exercise Videogames (EVG); (2) a supervised standard exercise program (Standard), using aerobic exercise equipment (e.g., treadmill, stationary bike); or (3) a Control condition. We will also examine the effect of home-based exercise videogames compared to a home-based standard PA program on MVPA maintenance during the 6-month follow up period. We will examine changes in cardiorespiratory fitness (i.e., estimated VO2max), blood pressure, resting heart rate, body composition and blood lipids at baseline, week 12 and at 6-months follow up. We will also examine changes in theoretically-based cognitive and affective constructs associated with physical activity including: enjoyment, outcome expectations, self-efficacy, motivation, and goal-orientation.

Study Type

Interventional

Enrollment (Actual)

283

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • The Miriam Hospital- CORO building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age > 18,
  • In generally good health
  • No medical conditions that would interfere with exercise
  • Currently engaging in less than 60 minutes of physical activity per week

Exclusion Criteria:

  • body mass index over 40
  • current or planned pregnancy
  • hospitalization from a physical or mental disorder in the past 6 months
  • hypertension (defined as: blood pressure ≥ 140/90)
  • anti-hypertensive medication
  • medications that may impair physical activity tolerance (e.g., beta blockers)
  • current cardiovascular disease
  • current pulmonary disease
  • diabetes
  • thyroid disorders
  • renal or liver disease
  • orthopedic conditions that would prevent or limit exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Videogames
Exercise videogames 3 times weekly for 12 weeks followed by 6 months of home practice
Behavioral: Exercise Video Games
12 weeks laboratory based exercise videogames
Behavioral: Home exercise videogames
videogame console and active videogames
Active Comparator: Standard Exercise
Exercise using aerobic equipment such as stationary bikes and treadmills 3 times weekly for 12 weeks followed by home practice
Behavioral: Aerobic Exercise
Stationary bike and/or treadmill walking for 12 weeks
Behavioral: Home Standard Exercise
Personalized physical activity promotion materials
No Intervention: Wellness Control
Weekly mailings on general health and wellness topics for 12 weeks followed by monthly mailings for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MVPA
Time Frame: 12 weeks
moderate to vigorous physical activity minutes
12 weeks
MVPA Maintenance
Time Frame: 6 months
moderate to vigorous physical activity minutes
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Beth Bock, PhD, The Miriam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Actual)

August 29, 2016

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

September 27, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 203711
  • R01HL109116 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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