- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04112329
Exergaming for Better Physical Fitness
Effects of 8 Weeks of High-intensity Exergaming on Cardiorespiratory Fitness and Physical Activity Levels in Sedentary Adults
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Trondheim, Norway, 7491
- Department of Circulation and Medical Imaging
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Exergaming
Will use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks
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will use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks.
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NO_INTERVENTION: Control
Asked to continue with their normal daily routine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
VO2max (Maximal Aerobic Capacity)
Time Frame: 8 weeks
|
8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure
Time Frame: 8 weeks
|
8 weeks
|
|
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Daily average energy expenditure
Time Frame: 8 weeks
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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
|
|
Daily average number of steps
Time Frame: 8 weeks
|
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
|
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Daily time in sedentary activity (< 3.0 metabolic equivalents = METs)
Time Frame: 8 weeks
|
Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and after intervention period (8 weeks).
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8 weeks
|
|
Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)
Time Frame: 8 weeks
|
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
|
|
Daily time in vigorous intensity activity (6.0-9.0 metabolic equivalents = METs)
Time Frame: 8 weeks
|
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
|
|
Daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs)
Time Frame: 8 weeks
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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
|
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Daily average total physical activity duration
Time Frame: 8 weeks
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Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and after intervention period (8 weeks).
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8 weeks
|
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Bioelectrical impedance
Time Frame: 8 weeks
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Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period and after intervention period (weeks).
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8 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019/1083
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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