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The goal of this clinical trial is to learn if physical exercise, cognitive stimulation, or a combination of both can improve mobility, cognitive function, and psychosocial well-being in institutionalized older adults aged 65 and older. The main questions it aims to answer are:
Researchers will compare the physical exercise group, the cognitive stimulation group, and the combined group to a control group that receives no active intervention to see which approach leads to the most improvement.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Exercise Group | Experimental | Participants will engage in moderate-intensity physical exercise sessions 3 times per week for 12 weeks (150 minutes per week), including balance, strength, and functional mobility exercises led by physiotherapists. |
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| Cognitive Stimulation Group | Experimental | Participants will attend 3 weekly sessions for 12 weeks, involving activities such as memory games, problem-solving tasks, orientation exercises, and attention training, led by a psychologist and a social educator. |
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| Combined Intervention Group | Experimental | Participants will receive both the physical exercise and cognitive stimulation programs simultaneously, with the same weekly frequency and duration as the individual interventions. |
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| Control Group | No Intervention | Participants will continue their usual routines without structured physical or cognitive interventions. They will receive standard care provided by the institution. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Exercise Program | Behavioral | Participants will complete supervised moderate-intensity physical exercise sessions three times per week for 12 weeks (totaling 150 minutes per week). The program includes balance, flexibility, strength, and mobility exercises designed according to WHO and ACSM guidelines for older adults. Sessions are delivered in small groups by trained physiotherapists. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Functional Mobility Measured by the Timed Up and Go (TUG) Test at 12 Weeks | Functional mobility will be assessed using the Timed Up and Go (TUG) test. The participant is timed while rising from a chair, walking 3 meters, turning, returning, and sitting. Score: Time in seconds (lower values indicate better mobility). | From baseline to the end of the intervention at 12 weeks. |
| Change from Baseline in Executive Function Assessed by the Stroop Test at 12 Weeks | Executive function will be assessed using the Stroop Color and Word Test, which evaluates attention, inhibition, and cognitive flexibility. Score: Time (seconds) and error count; lower values indicate better performance. | From baseline to the end of the intervention at 12 weeks. |
| Change from Baseline in Quality of Life Measured by EQ-5D at 12 Weeks | The EQ-5D assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Score Range: -0.594 to 1. Higher scores indicate better quality of life. | From baseline to the end of the intervention at 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Balance Performance Measured by the Tinetti Performance Oriented Mobility Assessment (POMA) at 12 Weeks | Balance will be evaluated using the Tinetti POMA. Score Range: 0-28 points. Higher scores indicate better balance and lower risk of falls. | From baseline to the end of the intervention at 12 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nuno S. Carvalho, Master | Contact | 0035-932364371 | nuno.carvalho@usal.es |
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| Cognitive Stimulation Program | Behavioral | Participants will attend cognitive stimulation sessions three times per week for 12 weeks. Activities include memory games, attention tasks, puzzles, orientation exercises, and problem-solving strategies. The sessions are led by a psychologist and a trained social educator, in small groups. |
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| Combined Physical Exercise and Cognitive Stimulation | Behavioral | Participants will receive both the physical exercise and cognitive stimulation interventions, conducted in parallel, over a 12-week period with three sessions per week. The combined program aims to improve physical and cognitive functions simultaneously and is delivered by a multidisciplinary team. |
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| Change in Lower Body Strength Measured by the 30-Second Chair Stand Test at 12 Weeks |
Participants will perform as many full stands as possible from a seated position in 30 seconds. Score: Number of stands. Higher numbers indicate better strength. |
| From baseline to the end of the intervention at 12 weeks. |
| Change in Upper Body Strength Measured by the Arm Curl Test at 12 Weeks | Upper body strength is assessed by the number of bicep curls in 30 seconds using a standardized weight (5 lbs for women, 8 lbs for men). Score: Number of repetitions. Higher scores indicate better strength. | From baseline to 12 weeks post-intervention. |
| Change in Grip Strength Measured by Hand Dynamometer at 12 Weeks | Grip strength is measured using a handheld dynamometer. Score: Kilograms (kg). Higher scores indicate stronger grip. | From baseline to 12 weeks post-intervention. |
| Change in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks | SThe PSQI evaluates sleep duration, disturbances, latency, and overall quality. Score Range: 0-21. Lower scores indicate better sleep quality. | From baseline to the end of the intervention at 12 weeks. |
| Change in Depressive Symptoms Measured by the Geriatric Depression Scale (GDS) at 12 Weeks | The GDS is a screening tool for depression in older adults. Score Range: 0-15. Lower scores indicate fewer depressive symptoms. | From baseline to the end of the intervention at 12 weeks. |
| Change in Life Satisfaction Measured by the Satisfaction With Life Scale (SWLS) at 12 Weeks | The SWLS measures global cognitive judgments of satisfaction with life. Score Range: 5-35. Higher scores indicate greater life satisfaction. | From baseline to the end of the intervention at 12 weeks. |
| Change in Functional Mobility Measured by the Timed Up and Go (TUG) Test at 6-Month Follow-Up | Follow-up assessment of mobility using the TUG test. | From the end of the intervention to 6 months follow-up. |
| Change in Executive Function Measured by the Stroop Test at 6-Month Follow-Up | Follow-up assessment of executive function using the Stroop Test. | From baseline to the end of the intervention at 12 weeks. |
| Change in Quality of Life Measured by the EQ-5D at 6-Month Follow-Up | Follow-up assessment using the EuroQol-5 Dimension (EQ-5D). | From end of intervention to 6 months post-intervention. |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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