Mental DisordersPHYSIOGAMENCT07387757
Exergames in Mental Health
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Mental Disorders, run by University of Salamanca at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2026to 15 May 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Mental Disorders
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION, Control
- Keywords
- Exergames, Physiotherapy, Exercise
- Medical subject headings
- Mental Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONProcedure or surgery
Also called Exergames with Nintendo Switch
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:
- Ring Fit Adventure (guided training, integrated breathing).
- Nintendo Switch Sports (overall movement, coordination).
- Just Dance (motivational cardiovascular activation).
ControlOther
Also called Control group
This group will continue to perform the usual intervention that has scheduled.
| Study group | Role | What they receive |
|---|---|---|
| Exergames | Experimental | Participants will undergo physical therapy based on active video games using the Nintendo Switch, with games selected for their ability to promote physical activity:
* Ring Fit Adventure (guided training, integrated breathing).
* Nintendo Switch Sports (overall movement, coordination).
* Just Dance (motivational cardiovascular activation). Receives: Other: Control |
| Conventional | Active comparator | This group will continue to carry out the usual intervention Receives: Procedure: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life: World Health Organization Quality of Life - BREF (WHOQOL-BREF)
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.
Measured: Day 1, day 15 and day 29
Secondary outcomes (2)
Motivation: Intrinsic Motivation Inventory (IMI)
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.
Measured: Day 1, day 15 and day 29
Adverse effects
Self-diary
Measured: Day 1, day 15 and day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Mar 2026
- Primary completion30 Apr 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inés Llamas-Ramos, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387757
- Sponsor's protocol ID
- MENTALHEALTH2026
- Acronym
- PHYSIOGAME
- Status last verified
- May 2026
- First submitted
- 17 Jan 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Physical Therapy Intervention Using Exergames in Mental Health
- ClinicalTrials.gov ID
- NCT07387757
- Acronym / sponsor ID
- PHYSIOGAME / MENTALHEALTH2026
- Conditions
- Mental Disorders
- Keywords
- Exergames, Physiotherapy, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 4 Feb 2026 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergames | Experimental | Other: ControlParticipants will undergo physical therapy based on active video games using the Nintendo Switch, with games selected for their ability to promote physical activity: * Ring Fit Adventure (guided training, integrated breathing). * Nintendo Switch Sports (overall movement, coordination). * Just Dance (motivational cardiovascular activation). |
| Conventional | Active comparator | Procedure: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONThis group will continue to carry out the usual intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATIONAlso: Exergames with Nintendo SwitchParticipants 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: * Ring Fit Adventure (guided training, integrated breathing). * Nintendo Switch Sports (overall movement, coordination). * Just Dance (motivational cardiovascular activation). | Procedure or surgery | Conventional |
| ControlAlso: Control groupThis group will continue to perform the usual intervention that has scheduled. | Other | Exergames |
Primary outcome
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.
2 secondary outcomes
Motivation: Intrinsic Motivation Inventory (IMI)
Time frame: Day 1, day 15 and day 29
Adverse effects
Time frame: Day 1, day 15 and day 29
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 20 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Mental Disorders, run by University of Salamanca at 1 site in Spain.
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 5 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 20 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 Spain. 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?
Quality of life: World Health Organization Quality of Life - BREF (WHOQOL-BREF) (time frame: Day 1, day 15 and day 29). 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 20 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.