- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06886867
Comparing Exergaming and Usual Care Physical Therapy in Nursing Home Residents
Physical Function in Older Adults: Exergaming vs. Usual Care in Physical Therapy - A Randomized Controlled Trial
The objective of this clinical trial is to compare the effects of exergaming and usual care physical therapy on physical function in older adults residing in nursing homes.
This trial seeks to answer the following key questions:
- Does physical function differ between interventions after treatment?
- How do these interventions impact enjoyment of therapy?
- Are there differences in adherence or perceived exertion between the interventions?
Study Overview
Status
Intervention / Treatment
Detailed Description
A single-blind, randomized controlled trial will be conducted to compare exergaming and usual care interventions. Participants will be recruited from nursing homes in the province of Toledo, and the study will follow the CONSORT guidelines for clinical, crossover, and parallel trials.
Two experimental groups will be tested, with interventions performed three days per week for six weeks, each session lasting approximately 30 minutes. The exergaming group will play seven video games from the Party Fowl app, while the usual care group will continue their standard exercise routine.
Outcome measures will be assessed at baseline, post-intervention (6 weeks), and at a 3-month follow-up to evaluate the middle-term effects of both interventions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Toledo
-
Añover de Tajo, Toledo, Spain, 45250
- Residencia de Mayores VIVENS
-
Fuensalida, Toledo, Spain, 45510
- Nueva Esperanza Nursing Home
-
Magán, Toledo, Spain, 45590
- Residencia Maranatha
-
Manzaneque, Toledo, Spain, 45460
- Residencial Montes de Toledo
-
Toledo, Toledo, Spain, 45071
- Universidad de Castilla-La Mancha
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- subjects over 60 years of age
- score equal to or greater than 20 on the Mini Mental cognitive test
- Subjects that present the ability to stand without the use of technical aids or with the technical assistance of a device used for walking.
Exclusion Criteria:
- severe visual impairment
- medical contraindication for physical activity
- pathology or problem that could prevent the test from being carried out.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exergaming
This group will perform approximately 28 minutes of exergaming 3 times a week for 6 weeks
|
Exergaming: Participants will perform different exercises through videogames
|
|
Active Comparator: Usual physical therapy care
This group will perform their usual care exercises treatments for approximately 28 minutes for 3 times a week for 6 weeks
|
Usual care: Different exercises will be performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical function
Time Frame: Baseline, post-intervention (6 weeks) and 3 months follow-up.
|
Physical function will be assessed using the Short Physical Performance Battery (SPPB)
|
Baseline, post-intervention (6 weeks) and 3 months follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand grip strength
Time Frame: Baseline, post-intervention (6 weeks) and 3 months follow-up.
|
Hand grip strength will be assessed using a hand dynamometer.
|
Baseline, post-intervention (6 weeks) and 3 months follow-up.
|
|
Exercise enjoyment
Time Frame: Post-intervention (6 weeks)
|
This outcome will be measured Physical Activity Enjoyment Scale (PACES).
Higher values indicate higher perceived satisfaction/ enjoyment.
|
Post-intervention (6 weeks)
|
|
Rate of Perceived Exertion
Time Frame: RPE will be measured inmediatley after the intervention
|
Rate of perceived exertion will be measured using Borg (RPE 1-10).
Higher values indicate higher levels of perceived exertion
|
RPE will be measured inmediatley after the intervention
|
|
Adherence
Time Frame: Through study completion (6 weeks), with a final adherence percentage calculated at the end of the intervention.
|
Adherence will be measured by the percentage of sessions attended of each participant.
|
Through study completion (6 weeks), with a final adherence percentage calculated at the end of the intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HBA-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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