Blood PressureNCT05712317
The Effectiveness of an Exergame-based Intervention
A study testing Exergame Intervention and Moderate-intensity endurance exercise in people with Blood Pressure and Physical Inactivity, run by University of Bern at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Physical Inactivity
- What is being tested?
- Exergame Intervention and Moderate-intensity endurance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2023to 1 Feb 2025
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Underlying health condition that could compromise the safety of the physical exercise
- Were taking cardiovascular medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Blood Pressure, Physical Inactivity
- Being tested
- Exergame Intervention, Moderate-intensity endurance exercise
- Keywords
- Exergaming, Blood pressure, Endurance performance, Pulse wave analysis, Exercise
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame InterventionBehavioural
8-week exergame-based intervention 3x per week
Moderate-intensity endurance exerciseBehavioural
8-week moderate-intensity endurance exercise 3x per week
| Study group | Role | What they receive |
|---|---|---|
| Exergame Intervention | Experimental | 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. Receives: Behavioral: Exergame Intervention |
| Moderate-intensity endurance exercise | Active comparator | 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. Receives: Behavioral: Moderate-intensity endurance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in maximum oxygen consumption at week 8
Maximum oxygen consumption will be obtained during a cardiopulmonary exercise test on a bicycle ergometer using a validated metabolic cart.
Measured: Baseline and week 8
Secondary outcomes (7)
Changes from baseline in pulse wave velocity at 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.
Measured: Baseline and week 8
Changes from baseline in systolic blood pressure at 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.
Measured: Baseline and week 8
Changes from baseline in diastolic blood pressure at 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.
Measured: Baseline and week 8
Changes from baseline in lifting biomechanics, measured by the sagittal curvature angle of the lumbar spine
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.
Measured: Baseline and week 8
Changes from baseline in lifting biomechanics, measured by the Stoop-Squat Index
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.
Measured: 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)
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.
Measured: Baseline and week 8
Changes from baseline in pain-related fear, measured by the Tampa Scale of Kinesiophobia (TSK; capturing general pain-related fear)
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.
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Mar 2023
- Primary completion1 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sascha Ketelhut, Dr., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712317
- Sponsor's protocol ID
- 2021-03-00006
- Status last verified
- May 2026
- First submitted
- 25 Jan 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be made available upon reasonable request from the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Regular Training in the ExerCube - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05712317
- Acronym / sponsor ID
- 2021-03-00006
- Conditions
- Blood Pressure, Physical Inactivity
- Keywords
- Exergaming, Blood pressure, Endurance performance, Pulse wave analysis, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 3 Feb 2023 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergame Intervention | Experimental | Behavioral: Exergame Intervention8-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. |
| Moderate-intensity endurance exercise | Active comparator | Behavioral: Moderate-intensity endurance exercise8-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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Underlying health condition that could compromise the safety of the physical exercise
- Were taking cardiovascular medications
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 |
|---|---|---|
| Exergame Intervention8-week exergame-based intervention 3x per week | Behavioural | Exergame Intervention |
| Moderate-intensity endurance exercise8-week moderate-intensity endurance exercise 3x per week | Behavioural | Moderate-intensity endurance exercise |
Primary outcome
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.
7 secondary outcomes
Changes from baseline in pulse wave velocity at week 8
Time frame: Baseline and week 8
Changes from baseline in systolic blood pressure at week 8
Time frame: Baseline and week 8
Changes from baseline in diastolic blood pressure at week 8
Time frame: 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
Changes from baseline in lifting biomechanics, measured by the Stoop-Squat Index
Time frame: 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
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
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 13 May 2026.
- Individual participant dataSharing planned: Yes. The data will be made available upon reasonable request from the principal investigator.
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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.
Sascha Ketelhut, Dr. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame Intervention and Moderate-intensity endurance exercise in people with Blood Pressure and Physical Inactivity, run by University of Bern at 1 site in Switzerland.
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 5 inclusion and 2 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 13 May 2026. 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 Switzerland. 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?
Changes from baseline in maximum oxygen consumption at week 8 (time frame: Baseline and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2026.