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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03298919
Other study ID # 203711
Secondary ID R01HL109116
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2012
Est. completion date September 30, 2017

Study information

Verified date September 2017
Source The Miriam Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 283
Est. completion date September 30, 2017
Est. primary completion date August 29, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise Video Games
12 weeks laboratory based exercise videogames
Aerobic Exercise
Stationary bike and/or treadmill walking for 12 weeks
Home exercise videogames
videogame console and active videogames
Home Standard Exercise
Personalized physical activity promotion materials

Locations

Country Name City State
United States The Miriam Hospital- CORO building Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
The Miriam Hospital National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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: 10.10 — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary MVPA moderate to vigorous physical activity minutes 12 weeks
Primary MVPA Maintenance moderate to vigorous physical activity minutes 6 months
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