- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07387757
Exergames in Mental Health (PHYSIOGAME)
Effectiveness of a Physical Therapy Intervention Using Exergames in Mental Health
Mental health and stress-related disorders have a growing impact on physical functioning, motivation, and participation in daily activities. Several studies indicate that integrating physical therapy into mental health programs improves functional status, reduces associated physical symptoms (fatigue, muscle tension, somatization), and promotes emotional regulation through movement. However, its implementation in clinical services remains limited. This project proposes to evaluate the effectiveness of an innovative mental health-oriented physical therapy program using active video games (exergames) on the Nintendo Switch platform, an accessible, motivating tool that can be adapted to each patient's functional level.
Objective: To determine whether a structured physiotherapy program based on exergames promotes physical exercise, improves quality of life, and increases therapeutic adherence in patients with mental illness.
Methods: An experimental pilot study will be conducted, implementing an intervention over 4 weeks, with 2 sessions per week lasting 40 minutes. Participants (n=12) will be assigned to an intervention group (exergames with Nintendo Switch) or a control group (usual routine). Quality of life, motivation, and therapeutic adherence will be assessed using the World Health Organization Quality of Life - BREF (WHOQOL-BREF) questionnaire, the Intrinsic Motivation Inventory, and a satisfaction questionnaire.
Expected results: The intervention group is expected to show better quality of life, greater motivation to exercise, and greater adherence to treatment. It is also expected to demonstrate that exergames are a viable tool, accepted by patients and incorporable into mental health physical therapy programs.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Salamanca
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Salamanca, Salamanca, Spain, 37007
- University of Salamanca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults between 18 and 65 years of age.
- Clinical diagnosis of mental illness.
- Psychopharmacological stability for at least 4 weeks prior to enrollment.
- Ability to perform light-moderate physical exercise.
- Written informed consent.
Exclusion Criteria:
- Severe psychiatric diagnoses with psychotic involvement or high suicide risk.
- Neurological or musculoskeletal conditions that limit the safe practice of exercise.
- Active substance use that interferes with the intervention.
- Moderate-severe cognitive impairment.
- Recent participation (<3 months) in other intervention studies.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Exergames
Participants will undergo physical therapy based on active video games using the Nintendo Switch, with games selected for their ability to promote physical activity:
|
This group will continue to perform the usual intervention that has scheduled.
Other Names:
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|
Active Comparator: Conventional
This group will continue to carry out the usual intervention
|
Participants will undergo physical therapy based on active video games using the Nintendo Switch, with games selected for their ability to promote physical activity, for 2 sessions/week, 40 minutes, for 4 weeks:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life: World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Time Frame: Day 1, day 15 and day 29
|
The WHOQOL-BREF is a questionnaire developed by the World Health Organization to assess perceived quality of life.
It is an abbreviated version of the WHOQOL-100 and contains 26 items that explore four main dimensions: physical health, psychological health, social relationships, and environment.
It also includes two general questions on the overall perception of quality of life and satisfaction with health.
It is a widely used, valid, and reliable instrument in different populations, providing a comprehensive and comparative view of people's well-being in their life context.
It has been used in psychiatric populations and in studies with people with various mental disorders, and there is scientific evidence of its use and psychometric properties in this context.
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Day 1, day 15 and day 29
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motivation: Intrinsic Motivation Inventory (IMI)
Time Frame: Day 1, day 15 and day 29
|
The Intrinsic Motivation Inventory (IMI) is a questionnaire designed to assess the degree of intrinsic motivation a person experiences when performing a specific activity.
It measures key psychological factors related to motivation, such as interest/enjoyment, perceived competence, effort, perceived value or usefulness of the task, pressure/stress, and experience of choice or autonomy.
It is a widely used tool in studies of motivation, learning, and adherence to intervention programs, as it provides insight into which aspects of an activity promote participant engagement and persistence.
The IMI has also been used in psychiatric populations and in studies related to mental health.
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Day 1, day 15 and day 29
|
|
Adverse effects
Time Frame: Day 1, day 15 and day 29
|
Self-diary
|
Day 1, day 15 and day 29
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
- Behavior
- Mental Disorders
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Pharmaceutical Preparations
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Technology, Pharmaceutical
- Exercise
- Control Groups
- Dosage Forms
- Exergaming
Other Study ID Numbers
- MENTALHEALTH2026
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
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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