NCT07387757

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

January 17, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

ExergamesPhysiotherapyExercise

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1, day 15 and day 29

Secondary Outcomes (2)

  • Motivation: Intrinsic Motivation Inventory (IMI)

    Day 1, day 15 and day 29

  • Adverse effects

    Day 1, day 15 and day 29

Study Arms (2)

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).

Other: Control

Conventional

ACTIVE COMPARATOR

This group will continue to carry out the usual intervention

Procedure: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Interventions

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).

Also known as: Exergames with Nintendo Switch
Conventional
ControlOTHER

This group will continue to perform the usual intervention that has scheduled.

Also known as: Control group
Exergames

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Salamanca

Salamanca, Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Mental DisordersMotor Activity

Interventions

ExerciseDosage FormsExergamingControl Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative TechniquesEpidemiologic Research DesignEpidemiologic MethodsResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2026

First Posted

February 4, 2026

Study Start

March 1, 2026

Primary Completion

April 30, 2026

Study Completion

May 15, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations