- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05712317
The Effectiveness of an Exergame-based Intervention
Evaluation of the Effectiveness of Regular Training in the ExerCube - A Randomized Controlled Trial
This randomized control trial aims to compare the effects of a regular exergame-based intervention and a regular moderate-intensity endurance exercise in healthy individuals. The main questions it aims to answer are:
• Is regular exergame-based training an effective intervention to improve different health and performance parameters in healthy adults? Can the exergaming intervention improve health and performance parameters similar to a moderate-intensity endurance exercise intervention? Throughout the intervention period (8 weeks), participants will participate in regular training sessions (3x/week) in an exergame called the ExerCube.
Researchers will compare the effects to a control group who participates in regular (3x/week) moderate-intensity endurance exercise to see if the exergaming intervention induces similar effects on health and performance parameters.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland, 3012
- University of Bern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy female and male adults
- Aged 18-60 years
- Free from acute and chronic diseases
- Free from movement restrictions or injuries to the musculoskeletal system
- Provided written informed consent
Exclusion Criteria:
- Underlying health condition that could compromise the safety of the physical exercise
- Were taking cardiovascular medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exergame Intervention
8-week exergame-based intervention consisting of 3 sessions per week lasting between 20-40 Minutes.
The intervention will consist of playing the game Sphery racer in the exergame called ExerCube.
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8-week exergame-based intervention 3x per week
|
|
Active Comparator: Moderate-intensity endurance exercise
8-week moderate-intensity endurance exercise consisting of 3 sessions per week lasting between 20-40 minutes.
The intervention will consist of a running exercise on a treadmill or riding on a bicycle ergometer.
|
8-week moderate-intensity endurance exercise 3x per week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from baseline in maximum oxygen consumption at week 8
Time Frame: Baseline and week 8
|
Maximum oxygen consumption will be obtained during a cardiopulmonary exercise test on a bicycle ergometer using a validated metabolic cart.
|
Baseline and week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from baseline in pulse wave velocity at week 8
Time Frame: Baseline and week 8
|
Pulse wave velocity will be obtained non-invasively using a clinically validated device for hemodynamic measurements.
After a 10 min supine rest, a minimum of two readings will be performed on the right upper arm using customized arm cuffs.
|
Baseline and week 8
|
|
Changes from baseline in systolic blood pressure at week 8
Time Frame: Baseline and week 8
|
Systolic blood pressure will be obtained non-invasively using a clinically validated device for hemodynamic measurements.
After a 10 min supine rest, a minimum of two readings will be performed on the right upper arm using customized arm cuffs.
|
Baseline and week 8
|
|
Changes from baseline in diastolic blood pressure at week 8
Time Frame: Baseline and week 8
|
Diastolic blood pressure will be obtained non-invasively using a clinically validated device for hemodynamic measurements.
After a 10 min supine rest, a minimum of two readings will be performed on the right upper arm using customized arm cuffs.
|
Baseline and week 8
|
|
Changes from baseline in lifting biomechanics, measured by the sagittal curvature angle of the lumbar spine
Time Frame: Baseline and week 8
|
The sagittal curvature angle of the lumbar spine will be used to assess lumbar spine posture during lifting.
It will be derived from kinematic recordings obtained using a skin marker-based motion capture system during standardized box-lifting tasks.
Higher values will indicate greater lumbar flexion, reflecting a more rounded lumbar posture, whereas lower values will indicate a more upright or extended lumbar posture.
Changes from baseline will be used to evaluate adaptations in lumbar movement strategy during lifting.
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Baseline and week 8
|
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Changes from baseline in lifting biomechanics, measured by the Stoop-Squat Index
Time Frame: Baseline and week 8
|
The Stoop-Squat Index will be used to quantify the relative contribution of trunk and knee motion during lifting, positioning the lifting strategy along a continuum from stoop-dominant to squat-dominant movement patterns.
It will be calculated from kinematic data obtained using a skin marker-based motion capture system during standardized box-lifting tasks.
Higher values will indicate a more stoop-dominant lifting strategy, characterized by greater trunk flexion and less knee flexion, whereas lower values will reflect a more squat-dominant lifting strategy.
Changes from baseline will be used to evaluate adaptations in lifting technique.
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Baseline and week 8
|
|
Changes from baseline in pain-related fear, measured by the Photograph Series of Daily Activities - Short Electronic Version (PHODA-SeV; capturing task-specific pain-related fear)
Time Frame: Baseline and week 8
|
The PHODA-SeV will be used to assess task-specific pain-related fear.
This validated, image-based questionnaire presents participants with 40 daily activities, which they will rate in terms of perceived harmfulness using a numerical rating scale from 0 to 100.
A score of 0 will indicate "not harmful," and a score of 100 will indicate "extremely harmful."
Higher scores will indicate greater perceived threat or fear associated with specific activities, whereas lower scores will indicate less task-specific pain-related fear.
Changes from baseline will be used to evaluate changes in task-specific pain-related fear.
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Baseline and week 8
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Changes from baseline in pain-related fear, measured by the Tampa Scale of Kinesiophobia (TSK; capturing general pain-related fear)
Time Frame: Baseline and week 8
|
The Tampa Scale of Kinesiophobia will be used to assess general fear of movement and fear of pain-related injury or reinjury.
The 17-item version of the questionnaire will be administered, with each item rated on a 4-point Likert scale.
Item scores will be summed to calculate a total score ranging from 17 to 68.
Higher scores will indicate greater pain-related fear, whereas lower scores will indicate less pain-related fear.
Changes from baseline will be used to evaluate changes in general pain-related fear.
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Baseline and week 8
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from baseline in body mass index at week 8
Time Frame: Baseline and week 8
|
Body mass index (BMI) will be assessed as a measure of body mass relative to height.
Body mass (in kilogramm) will be measured using a calibrated scale with participants wearing light clothing and no shoes.
Height (in meters) will be measured using a stadiometer with participants standing upright without shoes.
BMI will be calculated as body mass in kilograms divided by height in meters squared (kg/m²).
|
Baseline and week 8
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sascha Ketelhut, Dr., University of Bern
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-03-00006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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