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

Sponsor
University of Salamanca
Study ID
NCT07082504
Status
Not Yet Recruiting

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Conditions

  • Aging
  • Cognitive Abilities
  • Institutionalized Older Adults
  • Mobility and Independence
  • Well-being/Quality of Life

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.
  • 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.

Study Details

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

Key Dates

First listed
Jul 24, 2025
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Nov 1, 2026
Completion
Jul 30, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Physical Exercise Group
    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.
  • Experimental: Cognitive Stimulation Group
    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.
  • Experimental: Combined Intervention Group
    Participants will receive both the physical exercise and cognitive stimulation programs simultaneously, with the same weekly frequency and duration as the individual interventions.
  • No Intervention: Control Group
    Participants will continue their usual routines without structured physical or cognitive interventions. They will receive standard care provided by the institution.

Primary Outcome Measure

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. ]

Central Contacts

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