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

NCT ID: NCT07082504

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-05-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical Exercise Program

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Cognitive Stimulation Program

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Combined Physical Exercise and Cognitive Stimulation

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Nuno Adriano Sousa Carvalho

Doctoral Program Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nuno S. Carvalho, Master

Role: CONTACT

nuno.carvalho@usal.es

0035-932364371

Other Identifiers

1379

Identifier Type: -

Identifier Source: org_study_id