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Completed

NCT Number: NCT05712317

The Effectiveness of an Exergame-based Intervention

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bern

Bern, 3012, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exergame Intervention

Behavioral

8-week exergame-based intervention 3x per week

Moderate-intensity endurance exercise

Behavioral

8-week moderate-intensity endurance exercise 3x per week

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

Evaluation of the Effectiveness of Regular Training in the ExerCube - A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2023
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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