ClinicalTrials.gg
Not yet recruitingNCT07082504Updated Jul 10, 2026

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

An interventional study of Physical Exercise Program and Cognitive Stimulation Program in Aging, Institutionalized Older Adults and Cognitive Abilities, sponsored by University of Salamanca. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by University of Salamanca · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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
02

Conditions studied

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

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Keywords

  • Physical Exercise
  • Cognitive Stimulation
  • Executive Function
  • Quality of Life
  • Elderly Adults
  • Physical Function
  • Dual-Task Training
03

In context

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's planned enrollment of 140 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

University of Salamanca is the lead sponsor of 112 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study 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.

    Behavioral: Physical Exercise Program

  • 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.

    Behavioral: Cognitive Stimulation Program

  • 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.

    Behavioral: Combined Physical Exercise and Cognitive Stimulation

  • 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.

Interventions

  • BehavioralPhysical 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.

  • BehavioralCognitive 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.

  • BehavioralCombined 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: From baseline to the end of the intervention at 12 weeks.

  2. 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.

    Time frame: From baseline to the end of the intervention at 12 weeks.

  3. 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.

    Time frame: From baseline to the end of the intervention at 12 weeks.

Secondary outcomes

  1. 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.

    Time frame: From baseline to the end of the intervention at 12 weeks.

  2. 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.

    Time frame: From baseline to the end of the intervention at 12 weeks.

  3. 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.

    Time frame: From baseline to 12 weeks post-intervention.

  4. 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.

    Time frame: From baseline to 12 weeks post-intervention.

  5. 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.

    Time frame: From baseline to the end of the intervention at 12 weeks.

  6. 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.

    Time frame: From baseline to the end of the intervention at 12 weeks.

  7. 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.

    Time frame: From baseline to the end of the intervention at 12 weeks.

  8. 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.

    Time frame: From the end of the intervention to 6 months follow-up.

  9. Change in Executive Function Measured by the Stroop Test at 6-Month Follow-Up

    Follow-up assessment of executive function using the Stroop Test.

    Time frame: From baseline to the end of the intervention at 12 weeks.

  10. 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).

    Time frame: From end of intervention to 6 months post-intervention.

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Nov 2026, 3 months later.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 3 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2025
First posted
Jul 24, 2025
StartEst.
Aug 1, 2026
Primary completionEst.
Nov 1, 2026
CompletionEst.
Jul 30, 2027
Last update
Jul 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07082504
Responsible party
Nuno Adriano Sousa Carvalho (Doctoral Program Student, University of Salamanca) — Principal investigator
First posted
Jul 24, 2025
Start date
Aug 1, 2026 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Jul 10, 2026

Study contacts

Nuno S. Carvalho, Master
Contact
nuno.carvalho@usal.es
0035-932364371

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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