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| ID | Type | Description | Link |
|---|---|---|---|
| Line 1- MOVE ON | Other Grant/Funding Number | 8th Call for Research Projects and Talent Retention of UEMC-Valladolid Provincial Council |
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Population aging is associated with an increased risk of frailty, falls, and loss of autonomy. This pilot study aims to evaluate the effects of a program that combines multicomponent exercise and non-immersive virtual reality (MCE+VR-NI), compared with virtual reality alone (VR-NI) and usual treatment. The primary objective is to determine the program's impact on physical function, balance, cognition, and occupational participation in community-dwelling adults aged over 65 years.
This is a mixed-methods pilot study consisting of a two-arm randomized controlled trial and a non-randomized parallel cohort for the control group. Participants will be allocated in a 1:1:1 ratio to the intervention or control groups. The intervention period will last 8 weeks. Quantitative outcomes (SPPB, FRAIL Scale, TUG, MoCA, COPM, WHODAS 2.0) will be assessed at baseline and post-intervention. In addition, qualitative interviews will be conducted to explore participants' subjective experiences and motivation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicomponent Exercise + Virtual Reality Group (MCE+VR) | Experimental | 8-week combined program including strength, balance, and coordination training along with non-immersive virtual reality sessions. |
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| Virtual Reality Group (VR) | Active Comparator | 8-week program using exclusively non-immersive virtual reality sessions. |
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| Control Group | No Intervention | Parallel cohort maintaining usual activities and only participating in pre and post-intervention assessments |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent Exercise plus Non-Immersive Virtual Reality | Behavioral | Participants will undergo an 8-week multicomponent exercise program combined with non-immersive virtual reality (VR). Sessions will be conducted twice weekly (60 minutes each) and will include strength, balance, coordination, and functional mobility training, along with VR-based motor and cognitive stimulation using a non-immersive system. The intervention will be delivered in a supervised group setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical function (SPPB score) | Physical function will be assessed using the Short Physical Performance Battery (SPPB), which includes balance, gait speed, and chair stand tests, with a total score ranging from 0 to 12. Higher scores indicate better physical function. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mobility (Timed Up and Go test) | Mobility will be assessed using the Timed Up and Go (TUG) test. The time in seconds required to stand up from a chair, walk three meters, turn, walk back, and sit down will be recorded, with no fixed minimum or maximum score. Lower times indicate better mobility and lower fall risk. | Baseline and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olga I Fernández RodrÃguez, Dr. | Contact | +34 983 001 000 | oifernandez@uemc.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INNOVEAS Innovation Center, Spanish Red Cross (Valladolid), Spain | Valladolid | Valladolid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30703272 | Background | Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2. | |
| 34409961 | Background | Izquierdo M, Merchant RA, Morley JE, Anker SD, Aprahamian I, Arai H, Aubertin-Leheudre M, Bernabei R, Cadore EL, Cesari M, Chen LK, de Souto Barreto P, Duque G, Ferrucci L, Fielding RA, Garcia-Hermoso A, Gutierrez-Robledo LM, Harridge SDR, Kirk B, Kritchevsky S, Landi F, Lazarus N, Martin FC, Marzetti E, Pahor M, Ramirez-Velez R, Rodriguez-Manas L, Rolland Y, Ruiz JG, Theou O, Villareal DT, Waters DL, Won Won C, Woo J, Vellas B, Fiatarone Singh M. International Exercise Recommendations in Older Adults (ICFSR): Expert Consensus Guidelines. J Nutr Health Aging. 2021;25(7):824-853. doi: 10.1007/s12603-021-1665-8. |
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Individual participant data (IPD) will not be shared in order to protect participant privacy and confidentiality, in accordance with informed consent procedures and applicable data protection regulations. Due to the small sample size typical of pilot studies and the potential risk of indirect identification, only aggregated and anonymized data will be reported in scientific publications and communications. All analyses will be conducted at the group level. Data will be handled and stored securely following institutional and ethical guidelines.
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Outcome assessors will be blinded to the participants' group assignment.
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| Non-Immersive Virtual Reality | Behavioral | Participants will receive non-immersive virtual reality training for 8 weeks, with two supervised sessions per week (60 minutes each), focused on motor and cognitive stimulation. |
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| Change in handgrip strength | Handgrip strength will be measured in kilograms using a Jamar dynamometer, with no fixed minimum or maximum score. Higher values indicate greater muscular strength. | Baseline and 8 weeks |
| Change in cognitive function (MoCA score) | Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a screening tool that evaluates multiple cognitive domains including memory, attention, language, executive function, and visuospatial abilities, with a score ranging from 0 to 30. Higher scores indicate better cognitive function. | Baseline and 8 weeks |
| Change in frailty status (FRAIL Scale) | Frailty will be assessed using the FRAIL Scale, which includes five domains: fatigue, resistance, ambulation, illnesses, and weight loss, with a score ranging from 0 to 5. Higher scores indicate greater frailty. | Baseline and 8 weeks |
| Change in occupational performance and satisfaction (COPM) | Occupational performance and satisfaction will be assessed using the Canadian Occupational Performance Measure (COPM), which evaluates self-perceived performance and satisfaction in meaningful daily activities. Participants identify up to five priority activities in daily living, which are then rated for performance and satisfaction on scales ranging from 1 (not able to do it / not satisfied at all) to 10 (able to do it extremely well / extremely satisfied). Higher scores indicate better perceived performance and satisfaction. Changes in occupational performance will be assessed based on COPM scores. | Baseline and 8 weeks |
| Change in disability and participation (WHODAS 2.0) | Disability and participation will be assessed using the WHODAS 2.0 (36-item version), which evaluates functioning across multiple domains, with a standardized score ranging from 0 to 100. Higher scores indicate greater disability. | Baseline and 8 weeks |
| 24291597 | Background | Gine-Garriga M, Roque-Figuls M, Coll-Planas L, Sitja-Rabert M, Salva A. Physical exercise interventions for improving performance-based measures of physical function in community-dwelling, frail older adults: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2014 Apr;95(4):753-769.e3. doi: 10.1016/j.apmr.2013.11.007. Epub 2013 Nov 27. |