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CompletedNCT03298919Updated Apr 25, 2019

Efficacy of Exercise Videogames for Physical Activity Adoption and Maintenance

An interventional study of Exercise Video Games and Aerobic Exercise in Physical Activity, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-25.

Sponsored by The Miriam Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
283
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Physical Activity
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
283 participants (actual)

Study arms

  • Experimental
    Exercise Videogames

    Exercise videogames 3 times weekly for 12 weeks followed by 6 months of home practice

    Behavioral: Exercise Video Games · Behavioral: Home exercise 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 · Behavioral: Home Standard Exercise

  • No intervention
    Wellness Control

    Weekly mailings on general health and wellness topics for 12 weeks followed by monthly mailings for 6 months.

Interventions

  • BehavioralExercise Video Games

    12 weeks laboratory based exercise videogames

  • BehavioralAerobic Exercise

    Stationary bike and/or treadmill walking for 12 weeks

  • BehavioralHome exercise videogames

    videogame console and active videogames

  • BehavioralHome Standard Exercise

    Personalized physical activity promotion materials

05

What researchers measure

Primary outcomes

  1. MVPA

    moderate to vigorous physical activity minutes

    Time frame: 12 weeks

  2. MVPA Maintenance

    moderate to vigorous physical activity minutes

    Time frame: 6 months

06

Study locations

1 site
  • The Miriam Hospital- CORO building
    Providence, Rhode Island 02903, United States
07

References and documents

Publications

  • Serber ER, Ciccolo J, Palmer K, Cobb V, Tilkemeier PL, Bock BC. The feasibility of exercise videogames for cardiovascular risk reduction among adults: a pilot for "Wii heart fitness". J Sports Med Phys Fitness. 2016 Mar;56(3):319-27. Epub 2015 Feb 18. PubMed 25692860 ↗
  • Bock BC, Thind H, Dunsiger SI, Serber ER, Ciccolo JT, Cobb V, Palmer K, Abernathy S, Marcus BH. Exercise videogames for physical activity and fitness: Design and rationale of the Wii Heart Fitness trial. Contemp Clin Trials. 2015 May;42:204-12. doi: 10.1016/j.cct.2015.04.007. Epub 2015 Apr 17. PubMed 25896114 ↗
  • Bock BC, Dunsiger SI, Ciccolo JT, Serber ER, Wu WC, Tilkemeier P, Walaska KA, Marcus BH. Exercise Videogames, Physical Activity, and Health: Wii Heart Fitness: A Randomized Clinical Trial. Am J Prev Med. 2019 Apr;56(4):501-511. doi: 10.1016/j.amepre.2018.11.026. Epub 2019 Feb 16. PubMed 30777705 ↗
  • Bock BC, Dunsiger SI, Ciccolo JT, Serber ER, Wu WC, Sillice M, Marcus BH. Mediators of physical activity between standard exercise and exercise video games. Health Psychol. 2019 Dec;38(12):1107-1115. doi: 10.1037/hea0000791. Epub 2019 Sep 12. PubMed 31512923 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03298919
Lead sponsor
The Miriam Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Oct 2, 2017
Start date
Sep 1, 2012
Primary completion
Aug 29, 2016
Completion
Sep 30, 2017
Last update
Apr 25, 2019

Study contacts

Beth Bock, PhD
principal investigator · The Miriam Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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