NCT Number: NCT07082504
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
Trial opening soon.
Get Notified65 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 12 weeks post-intervention.
Grip strength is measured using a handheld dynamometer. Score: Kilograms (kg). Higher scores indicate stronger grip.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the end of the intervention to 6 months follow-up.
Follow-up assessment of mobility using the TUG test.
Time frame: From baseline to the end of the intervention at 12 weeks.
Follow-up assessment of executive function using the Stroop Test.
Time frame: From end of intervention to 6 months post-intervention.
Follow-up assessment using the EuroQol-5 Dimension (EQ-5D).
Contact information is provided by the study sponsor or research team.
University of Salamanca
Other
Effects of Physical Exercise Programs, Cognitive Stimulation, and Their Combination on Mobility, Cognitive Function, and Psychosocial Well-Being in Institutionalized Older Adults
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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