Physical ActivityNCT03298919
Efficacy of Exercise Videogames for Physical Activity Adoption and Maintenance
A study testing Exercise Video Games, Aerobic Exercise and Home exercise videogames in people with Physical Activity, run by The Miriam Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Exercise Video Games, Aerobic Exercise and Home exercise videogames
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2012to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- current cardiovascular disease
- current pulmonary disease
- diabetes
- thyroid disorders
- renal or liver disease
- orthopedic conditions that would prevent or limit exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital- CORO building
Providence, Rhode Island, 02903
About this study
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.
- Conditions
- Physical Activity
- Being tested
- Exercise Video Games, Aerobic Exercise, Home exercise videogames, Home Standard Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Video GamesBehavioural
12 weeks laboratory based exercise videogames
Aerobic ExerciseBehavioural
Stationary bike and/or treadmill walking for 12 weeks
Home exercise videogamesBehavioural
videogame console and active videogames
Home Standard ExerciseBehavioural
Personalized physical activity promotion materials
| Study group | Role | What they receive |
|---|---|---|
| Exercise Videogames | Experimental | Exercise videogames 3 times weekly for 12 weeks followed by 6 months of home practice Receives: Behavioral: Exercise Video Games; Behavioral: 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 Receives: Behavioral: Aerobic Exercise; Behavioral: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MVPA
moderate to vigorous physical activity minutes
Measured: 12 weeks
MVPA Maintenance
moderate to vigorous physical activity minutes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start1 Sep 2012
- Primary completion29 Aug 2016
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Beth Bock, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298919
- Sponsor's protocol ID
- 203711
- Other IDs
- R01HL109116
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2017
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 25692860Bock 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 25896114Bock 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 30777705Bock 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Exercise Videogames for Physical Activity Adoption and Maintenance
- ClinicalTrials.gov ID
- NCT03298919
- Acronym / sponsor ID
- 203711
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 29 Aug 2016 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3-group design
| Arm | Type | Receives |
|---|---|---|
| Exercise Videogames | Experimental | Behavioral: Exercise Video Games, Behavioral: Home exercise videogamesExercise videogames 3 times weekly for 12 weeks followed by 6 months of home practice |
| Standard Exercise | Active comparator | Behavioral: Aerobic Exercise, Behavioral: Home Standard ExerciseExercise using aerobic equipment such as stationary bikes and treadmills 3 times weekly for 12 weeks followed by home practice |
| Wellness Control | No intervention | –Weekly mailings on general health and wellness topics for 12 weeks followed by monthly mailings for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Video Games12 weeks laboratory based exercise videogames | Behavioural | Exercise Videogames |
| Aerobic ExerciseStationary bike and/or treadmill walking for 12 weeks | Behavioural | Standard Exercise |
| Home exercise videogamesvideogame console and active videogames | Behavioural | Exercise Videogames |
| Home Standard ExercisePersonalized physical activity promotion materials | Behavioural | Standard Exercise |
Primary outcome
MVPA
Time frame: 12 weeks
moderate to vigorous physical activity minutes
MVPA Maintenance
Time frame: 6 months
moderate to vigorous physical activity minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Background: PubMed 25692860Serber 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.
- Results publication: PubMed 25896114Bock 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.
- Results publication: PubMed 30777705Bock 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.
- Derived from this study: PubMed 31512923Bock 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.
- Individual participant dataSharing planned: No
Related trials for Physical Activity
Not yet recruiting
Using e-Technologies to Maximize Physical Activity After Cancer Treatment
Cancer
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Not yet recruiting
Evaluation of Exercise With Overdressing to Induce Heat Acclimation in an Average Fitness Warfighter
Heat Acclimation and Thermotolerance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Bock, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Video Games, Aerobic Exercise and Home exercise videogames in people with Physical Activity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MVPA (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03298919, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.