Clinical trial NCT03298919: Efficacy of Exercise Videogames for Physical Activity Adoption and Maintenance
Official title: Efficacy of Exercise Videogames for Physical Activity Adoption and Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-10-02
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-group design
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: MVPA
timeFrame: 12 weeks
measure: MVPA Maintenance
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital- CORO building
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Beth Bock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.