About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals of both sexes.
Age 65 years or older.
Retired.
Institutionalized for more than three months.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Physical Exercise Program
BehavioralParticipants 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.
Cognitive Stimulation Program
BehavioralParticipants 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.
Combined Physical Exercise and Cognitive Stimulation
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
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.
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.
Secondary outcomes
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.
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.
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.
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.
Locations
Sponsors and contacts
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