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

NCT07082504 | Not Yet Recruiting

• 1 other identifier: 1379
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Keywords

Physical Exercise; Cognitive Stimulation; Executive Function; Quality of Life; Elderly Adults; Physical Function; Dual-Task Training

Outcome Measures

Primary Outcomes (3)

• 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).

  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

  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.

  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

  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.

  From baseline to the end of the intervention at 12 weeks.

Secondary Outcomes (10)

• 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.

• 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.

• Change in Upper Body Strength Measured by the Arm Curl Test at 12 Weeks

  From baseline to 12 weeks post-intervention.

• Change in Grip Strength Measured by Hand Dynamometer at 12 Weeks

  From baseline to 12 weeks post-intervention.

• 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.

Study Arms (4)

Physical Exercise Group

EXPERIMENTAL

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.

Behavioral: Physical Exercise Program

Cognitive Stimulation Group

EXPERIMENTAL

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.

Behavioral: Cognitive Stimulation Program

Combined Intervention Group

EXPERIMENTAL

Participants will receive both the physical exercise and cognitive stimulation programs simultaneously, with the same weekly frequency and duration as the individual interventions.

Behavioral: Combined Physical Exercise and Cognitive Stimulation

Control Group

NO INTERVENTION

Participants will continue their usual routines without structured physical or cognitive interventions. They will receive standard care provided by the institution.

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.

Physical Exercise Group

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.

Cognitive Stimulation Group

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.

Combined Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Nuno S. Carvalho, Master

CONTACT

0035-932364371; nuno.carvalho@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Program Student

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 24, 2025
• Study Start: September 1, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07