Effects of Exercise, Cognitive Training, and Their Combination in Institutionalized Older Adults

Official title

Effects of Physical Exercise Programs, Cognitive Stimulation, and Their Combination on Mobility, Cognitive Function, and Psychosocial Well-Being in Institutionalized Older Adults

Overview

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

Interventions

• Behavioral Physical Exercise Program
  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.
• Behavioral Cognitive Stimulation Program
  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.
• Behavioral Combined Physical Exercise and Cognitive Stimulation
  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.

Primary outcome measures

• Change from Baseline in Functional Mobility Measured by the Timed Up and Go (TUG) Test at 12 Weeks [Time frame: 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 [Time frame: 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 [Time frame: From baseline to the end of the intervention at 12 weeks.]

Secondary outcome measures (10)

• Change in Balance Performance Measured by the Tinetti Performance Oriented Mobility Assessment (POMA) at 12 Weeks [Time frame: From baseline to the end of the intervention at 12 weeks.]
• Change in Lower Body Strength Measured by the 30-Second Chair Stand Test at 12 Weeks [Time frame: 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 [Time frame: From baseline to 12 weeks post-intervention.]
• Change in Grip Strength Measured by Hand Dynamometer at 12 Weeks [Time frame: From baseline to 12 weeks post-intervention.]
• Change in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From end of intervention to 6 months post-intervention.]

Eligibility criteria

Inclusion criteria

• Individuals of both sexes.
• Age 65 years or older.
• Retired.
• Institutionalized for more than three months.
• Provide informed consent and agree to participate.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07082504 · 1379

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗