AgingNCT07082504
Effects of Exercise, Cognitive Training, and Their Combination in Institutionalized Older Adults
A study testing Physical Exercise Program, Cognitive Stimulation Program and Combined Physical Exercise and Cognitive Stimulation in people with Aging and Institutionalized Older Adults, run by University of Salamanca.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging, Institutionalized Older Adults, Cognitive Abilities
- What is being tested?
- Physical Exercise Program, Cognitive Stimulation Program and Combined Physical Exercise and Cognitive Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Individuals of both sexes.
- Age 65 years or older.
- Retired.
- Institutionalized for more than three months.
- Provide informed consent and agree to participate.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Physical Exercise Programs, Cognitive Stimulation, and Their Combination on Mobility, Cognitive Function, and Psychosocial Well-Being in Institutionalized Older Adults
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?
Read more
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
- Being tested
- Physical Exercise Program, Cognitive Stimulation Program, Combined Physical Exercise and Cognitive Stimulation
- Keywords
- Physical Exercise, Cognitive Stimulation, Executive Function, Quality of Life, Elderly Adults, Physical Function, Dual-Task Training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Exercise ProgramBehavioural
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 ProgramBehavioural
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 StimulationBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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
Balance will be evaluated using the Tinetti POMA. Score Range: 0-28 points. Higher scores indicate better balance and lower risk of falls.
Measured: 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
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.
Measured: 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
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.
Measured: From baseline to 12 weeks post-intervention.
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.
Measured: From baseline to 12 weeks post-intervention.
Change in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks
SThe PSQI evaluates sleep duration, disturbances, latency, and overall quality. Score Range: 0-21. Lower scores indicate better sleep quality.
Measured: 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
The GDS is a screening tool for depression in older adults. Score Range: 0-15. Lower scores indicate fewer depressive symptoms.
Measured: 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
The SWLS measures global cognitive judgments of satisfaction with life. Score Range: 5-35. Higher scores indicate greater life satisfaction.
Measured: 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
Follow-up assessment of mobility using the TUG test.
Measured: 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
Follow-up assessment of executive function using the Stroop Test.
Measured: 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
Follow-up assessment using the EuroQol-5 Dimension (EQ-5D).
Measured: From end of intervention to 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Aug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuno Adriano Sousa Carvalho, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082504
- Sponsor's protocol ID
- 1379
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Exercise Programs, Cognitive Stimulation, and Their Combination on Mobility, Cognitive Function, and Psychosocial Well-Being in Institutionalized Older Adults
- ClinicalTrials.gov ID
- NCT07082504
- Acronym / sponsor ID
- 1379
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physical Exercise Group | Experimental | Behavioral: Physical Exercise ProgramParticipants 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. |
| Cognitive Stimulation Group | Experimental | Behavioral: Cognitive Stimulation ProgramParticipants 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. |
| Combined Intervention Group | Experimental | Behavioral: Combined Physical Exercise and Cognitive StimulationParticipants will receive both the physical exercise and cognitive stimulation programs simultaneously, with the same weekly frequency and duration as the individual interventions. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Individuals of both sexes.
- Age 65 years or older.
- Retired.
- Institutionalized for more than three months.
- Provide informed consent and agree to participate.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Exercise ProgramParticipants 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. | Behavioural | Physical Exercise Group |
| Cognitive Stimulation ProgramParticipants 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. | Behavioural | Cognitive Stimulation Group |
| Combined Physical Exercise and Cognitive StimulationParticipants 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. | Behavioural | Combined Intervention Group |
Primary outcome
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.
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
Time frame: From baseline to the end of the intervention 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
Time frame: From baseline to the end of the intervention 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.
10 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise Program, Cognitive Stimulation Program and Combined Physical Exercise and Cognitive Stimulation in people with Aging and Institutionalized Older Adults, run by University of Salamanca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nuno S. Carvalho, Master (0035-932364371, nuno.carvalho@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.