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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03513380
Other study ID # 2017/1501
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 25, 2018
Est. completion date November 30, 2019

Study information

Verified date December 2019
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this project is to assess if playing a newly developed videogame that require physical activity (e.g. exergame) can lead to health benefits. The project will include 50 adult participants that are not particularly physically active. They will be randomized into two groups where one group will be given free access to the exergame for 6 months. The physical fitness (maximal oxygen consumption), blood markers of cardiometabolic health and body composition of the subjects will be tested before, mid-ways and after the intervention period. Also, the participants gaming frequency will be registered throughout the 6-month period. Aim of this study is to investigate if access to this game can provide health benefits for individuals who are not motivated to take part in regular physical activity.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date November 30, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Sedentary (<150 mins of moderate intensity physical activity/week)

- Able to ride a bike for up to 60 minutes

Exclusion Criteria:

- Known cardiovascular disease

- Taking beta-blockers or anti-arrhythmic drugs

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exergaming
free access to the exergame PedalTanks during 6 months

Locations

Country Name City State
Norway Department of Circulation and Medical Imaging Trondheim

Sponsors (1)

Lead Sponsor Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary VO2max (Maximal Aerobic Capacity) 3 months
Primary VO2max (Maximal Aerobic Capacity) 6 months
Secondary Daily average energy expenditure Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months. 3 and 6 months
Secondary Daily average number of steps Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months. 3 and 6 months
Secondary Daily time in sedentary activity (< 3.0 metabolic equivalents = METs) Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months. 3 and 6 months
Secondary Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs) Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months. 3 and 6 months
Secondary Daily time in vigorous intensity activity (6.0-9.0 metabolic equivalents = METs) Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months. 3 and 6 months
Secondary Daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs) Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months. 3 and 6 months
Secondary Daily average total physical activity duration Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months. 3 and 6 months
Secondary Bioelectrical impedance Body composition assessed using bioelectrical impedance analysis (InBody 720) 3 and 6 months
Secondary Blood Pressure 3 and 6 months
Secondary Fasting circulating glucose, as blood marker of cardiometabolic health 6 months
Secondary Lipid profile, as blood marker of cardiometabolic health 6 months
Secondary Circulating insulin concentration, as blood marker of cardiometabolic health 6 months
Secondary glucose response to a 2 hour glucose tolerance test, as blood marker of cardiometabolic health 6 months
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