Effects of Exercise, Cognitive Training, and Their Combination in Institutionalized Older Adults
- Conditions
- AgingInstitutionalized Older AdultsCognitive AbilitiesMobility and IndependenceWell-being/Quality of Life
- Registration Number
- NCT07082504
- Lead Sponsor
- University of Salamanca
- Brief Summary
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:
* Does physical exercise improve strength, flexibility, balance, and mobility?
* Does cognitive stimulation improve executive function and mental state?
* Does combining both interventions provide greater benefits than either intervention alone?
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:
* Take part in either physical exercise, cognitive stimulation, or both, 3 times per week for 12 weeks
* Complete assessments before the intervention, after 12 weeks, and again after 6 months
* Answer questionnaires and perform physical and cognitive tests to measure changes in health and well-being
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- Individuals of both sexes.
- Age 65 years or older.
- Retired.
- Institutionalized for more than three months.
- Provide informed consent and agree to participate.
- Lack of cooperation or cognitive capacity to participate.
- Diagnosis of dementia or Alzheimer's disease.
- Presence of acute medical conditions.
- Physical or cognitive impairments that prevent completion of study procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from Baseline in Functional Mobility Measured by the Timed Up and Go (TUG) Test at 12 Weeks From baseline to the end of the intervention 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).Change from Baseline in Executive Function Assessed by the Stroop Test at 12 Weeks From baseline to the end of the intervention 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.Change from Baseline in Quality of Life Measured by EQ-5D at 12 Weeks From baseline to the end of the intervention 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.
- Secondary Outcome Measures
Name Time Method Change in Balance Performance Measured by the Tinetti Performance Oriented Mobility Assessment (POMA) at 12 Weeks From baseline to the end of the intervention 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.
Change in Lower Body Strength Measured by the 30-Second Chair Stand Test at 12 Weeks From baseline to the end of the intervention 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.Change in Upper Body Strength Measured by the Arm Curl Test at 12 Weeks From baseline to 12 weeks post-intervention. 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.Change in Grip Strength Measured by Hand Dynamometer at 12 Weeks From baseline to 12 weeks post-intervention. Grip strength is measured using a handheld dynamometer. Score: Kilograms (kg). Higher scores indicate stronger grip.
Change in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks From baseline to the end of the intervention at 12 weeks. SThe PSQI evaluates sleep duration, disturbances, latency, and overall quality. Score Range: 0-21. Lower scores indicate better sleep quality.
Change in Depressive Symptoms Measured by the Geriatric Depression Scale (GDS) at 12 Weeks From baseline to the end of the intervention at 12 weeks. The GDS is a screening tool for depression in older adults. Score Range: 0-15. Lower scores indicate fewer depressive symptoms.
Change in Life Satisfaction Measured by the Satisfaction With Life Scale (SWLS) at 12 Weeks From baseline to the end of the intervention at 12 weeks. The SWLS measures global cognitive judgments of satisfaction with life. Score Range: 5-35. Higher scores indicate greater life satisfaction.
Change in Functional Mobility Measured by the Timed Up and Go (TUG) Test at 6-Month Follow-Up From the end of the intervention to 6 months follow-up. Follow-up assessment of mobility using the TUG test.
Change in Executive Function Measured by the Stroop Test at 6-Month Follow-Up From baseline to the end of the intervention at 12 weeks. Follow-up assessment of executive function using the Stroop Test.
Change in Quality of Life Measured by the EQ-5D at 6-Month Follow-Up From end of intervention to 6 months post-intervention. Follow-up assessment using the EuroQol-5 Dimension (EQ-5D).