Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:10 AM
Study NCT ID:
NCT07387757
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exergames in Mental Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D000088544', 'term': 'Exergaming'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-29', 'studyFirstSubmitDate': '2026-01-17', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life: World Health Organization Quality of Life - BREF (WHOQOL-BREF)', 'timeFrame': 'Day 1, day 15 and day 29', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Motivation: Intrinsic Motivation Inventory (IMI)', 'timeFrame': 'Day 1, day 15 and day 29', 'description': '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.'}, {'measure': 'Adverse effects', 'timeFrame': 'Day 1, day 15 and day 29', 'description': 'Self-diary'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exergames', 'Physiotherapy', 'Exercise'], 'conditions': ['Mental Disorders']}, 'descriptionModule': {'briefSummary': "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.\n\nObjective: 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.\n\nMethods: 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.\n\nExpected 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between 18 and 65 years of age.\n* Clinical diagnosis of mental illness.\n* Psychopharmacological stability for at least 4 weeks prior to enrollment.\n* Ability to perform light-moderate physical exercise.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Severe psychiatric diagnoses with psychotic involvement or high suicide risk.\n* Neurological or musculoskeletal conditions that limit the safe practice of exercise.\n* Active substance use that interferes with the intervention.\n* Moderate-severe cognitive impairment.\n* Recent participation (\\<3 months) in other intervention studies.'}, 'identificationModule': {'nctId': 'NCT07387757', 'acronym': 'PHYSIOGAME', 'briefTitle': 'Exergames in Mental Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Salamanca'}, 'officialTitle': 'Effectiveness of a Physical Therapy Intervention Using Exergames in Mental Health', 'orgStudyIdInfo': {'id': 'MENTALHEALTH2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exergames', 'description': 'Participants will undergo physical therapy based on active video games using the Nintendo Switch, with games selected for their ability to promote physical activity:\n\n* Ring Fit Adventure (guided training, integrated breathing).\n* Nintendo Switch Sports (overall movement, coordination).\n* Just Dance (motivational cardiovascular activation).', 'interventionNames': ['Other: Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'description': 'This group will continue to carry out the usual intervention', 'interventionNames': ['Procedure: EXERCISE TRAINING WITH OR WITHOUT MEDICATION']}], 'interventions': [{'name': 'EXERCISE TRAINING WITH OR WITHOUT MEDICATION', 'type': 'PROCEDURE', 'otherNames': ['Exergames with Nintendo Switch'], 'description': '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:\n\n* Ring Fit Adventure (guided training, integrated breathing).\n* Nintendo Switch Sports (overall movement, coordination).\n* Just Dance (motivational cardiovascular activation).', 'armGroupLabels': ['Conventional']}, {'name': 'Control', 'type': 'OTHER', 'otherNames': ['Control group'], 'description': 'This group will continue to perform the usual intervention that has scheduled.', 'armGroupLabels': ['Exergames']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37007', 'city': 'Salamanca', 'state': 'Salamanca', 'country': 'Spain', 'contacts': [{'name': 'Inés Llamas-Ramos', 'role': 'CONTACT', 'email': 'inesllamas@usal.es', 'phone': '+034 630720990'}], 'facility': 'University of Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'centralContacts': [{'name': 'Inés Llamas-Ramos Dr.', 'role': 'CONTACT', 'email': 'inesllamas@usal.es', 'phone': '+34630720990'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Salamanca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Inés Llamas-Ramos', 'investigatorAffiliation': 'University of Salamanca'}}}}