NCT03298919

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
283

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

September 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
Last Updated

April 25, 2019

Status Verified

September 1, 2017

Enrollment Period

4 years

First QC Date

September 27, 2017

Last Update Submit

April 23, 2019

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (2)

  • MVPA

    moderate to vigorous physical activity minutes

    12 weeks

  • MVPA Maintenance

    moderate to vigorous physical activity minutes

    6 months

Study Arms (3)

Exercise Videogames

EXPERIMENTAL

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

Behavioral: Exercise Video GamesBehavioral: Home exercise videogames

Standard Exercise

ACTIVE COMPARATOR

Exercise using aerobic equipment such as stationary bikes and treadmills 3 times weekly for 12 weeks followed by home practice

Behavioral: Aerobic ExerciseBehavioral: Home Standard Exercise

Wellness Control

NO INTERVENTION

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

Interventions

Exercise Video GamesBEHAVIORAL

12 weeks laboratory based exercise videogames

Exercise Videogames
Aerobic ExerciseBEHAVIORAL

Stationary bike and/or treadmill walking for 12 weeks

Standard Exercise
Home exercise videogamesBEHAVIORAL

videogame console and active videogames

Exercise Videogames
Home Standard ExerciseBEHAVIORAL

Personalized physical activity promotion materials

Standard Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital- CORO building

Providence, Rhode Island, 02903, United States

Location

Related Publications (4)

  • 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.

    PMID: 25692860BACKGROUND

  • 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.

    PMID: 25896114RESULT

  • 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.

    PMID: 30777705RESULT

  • 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.

    PMID: 31512923DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Beth Bock, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3-group design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 2, 2017

Study Start

September 1, 2012

Primary Completion

August 29, 2016

Study Completion

September 30, 2017

Last Updated

April 25, 2019

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)