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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04112329
Other study ID # 2019/1083
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2019
Est. completion date March 1, 2020

Study information

Verified date May 2021
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 increased physical activity, aerobic fitness and health benefits in sedentary adults. The project will include 28 sedentary adults, 18 years and above, who are not sufficiently active according to current guidelines defined as doing (<150 minutes/week of moderate intensity physical activity or <75 minutes/week of vigorous physical activity and/or do not do any regular endurance training ). The physical fitness (maximal oxygen consumption), blood pressure, body composition and objectively measured physical activity will be tested before and after the intervention period. Also, the participants gaming frequency will be registered throughout the 8 week period. Aim of this study is to investigate if access to this game can provide health benefits for adults who are not motivated to take part in regular physical activity.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Sedentary (<150 mins of moderate intensity physical activity/week) and/or do not regularly take part in endurance training. - 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
will use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks.

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, 

References & Publications (1)

Berg J, Haugen G, Wang AI, Moholdt T. High-intensity exergaming for improved cardiorespiratory fitness. A randomised, controlled trial. Eur J Sport Sci. 2021 May 4:1-30. doi: 10.1080/17461391.2021.1921852. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary VO2max (Maximal Aerobic Capacity) 8 weeks
Secondary Daily average energy expenditure Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and after intervention period (8 weeks). 8 weeks
Secondary Daily average number of steps Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and after intervention period (8 weeks). 8 weeks
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 and after intervention period (8 weeks). 8 weeks
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 and after intervention period (8 weeks). 8 weeks
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 and after intervention period (8 weeks). 8 weeks
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 and after intervention period (8 weeks). 8 weeks
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 and after intervention period (8 weeks). 8 weeks
Secondary Bioelectrical impedance Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and after intervention period (weeks). 8 weeks
Secondary Blood Pressure 8 weeks
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