- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06130878
Rhythmic Exercise in Older Adults With Cognitive Impairment
April 9, 2025 updated by: Agustín Aibar Almazán, University of Jaén
Effects of a Rhythmic Exercise Program on the Physical, Mental and Cognitive Performance of Older Adults With Cognitive Impairment.
Rhythmic physical exercise is a very promising non-pharmaceutical tool to prevent or reduce cognitive decline that occurs in people sixty years of age or older.
The main objective is to determine the effect of a rhythmic exercise program on the physical, mental and cognitive performance of older adults with cognitive impairment.
The main variables of the study will be: global cognitive function evaluated by the Mini Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA); attention and executive functions evaluated using the Trail Making Test (TMT) part A and B. As secondary variables, the functional abilities evaluated using the Senior Fitness Test (SFT) will be taken into account.
Additionally, sociodemographic variables and variables related to health status will be evaluated.
These will take into account the quality of sleep evaluated with the Pittsburgh index, the nutritional status evaluated using the Mini Nutritional Assessment-Short Form (MNA-SF) scale, and the Stress and anxiety levels will be assessed using the Depression Anxiety Stress Scales-21 (DASS-21).
All variables will be evaluated before the intervention and after it.
After the intervention, it is expected that the exercise program will improve the neurocognitive performance, as well as the functional and psychological abilities of older adults.
Study Overview
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jaén, Spain
- U.E.D. Virgen de la Capilla
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Be 60 years old or older
- Do not participate in any physical exercise program
- Present physical autonomy to participate in the physical activities required by the study.
- Present scores of > 25 on the MMSE
- Present current affiliation to the social health security system.
- Sign the informed consent
- Understand the instructions, programs and protocols of this project.
- Complete more than 90% of the intervention with exercise.
Exclusion Criteria:
- Present medical contraindications for performing physical tests.
- Present diseases that limit cognitive performance and physical activity.
- Present vestibular diseases
- Present rheumatological diseases that can be exacerbated by stress articulate.
- Refusing to sign the informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Group (CG)
This group does not receive any treatment.
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Experimental: EXPERIMENTAL GROUP (EG)
People assigned to this group will undergo a 12-week physical training intervention
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A multicomponent rhythmic physical training will be carried out, with a predominance of QMT, following the principles of "Animal Flow" [46] and including the following components: wrist mobilizations; activations; specific stretching positions; special locomotor movements or "traveling forms"; interruptions and transitions with dynamic movements and choreographic sequences of "Flow".
Aspects related to the control of intensity, volume and progression strategy have yet to be defined.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Short Form-36 Health Survey (SF-36)
Time Frame: Up to twelve weeks
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Used extensively for assessing health-related quality of life.
The results are values between 0 and 100.
Optimal health is represented by scores of 100 and very poor health would equal 0.
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Up to twelve weeks
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Mini-Mental State Examination (MMSE)
Time Frame: Up to twelve weeks
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The most widely used cognitive screening test to assess suspected symptoms consistent with cognitive impairment or dementia.
Written test with a maximum score of 30.
The cut-off point established for the MMSE defines "normal" cognitive function is generally set at 24, lower scores indicate more serious cognitive problems.
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Up to twelve weeks
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MoCA (Montreal Cognitive Assessment)
Time Frame: Up to twelve weeks
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Instrument that examines the skills of attention, concentration, executive functions, memory, language, visuoconstructive abilities, calculation and orientation and the maximum score is 30.
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Up to twelve weeks
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The Yesavage Geriatric Depression Scale
Time Frame: Up to twelve weeks
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Questionnaire used to screen for depression in older people.
Scores from 00 to 05 indicate Normal screening, 06 to 10 Moderate Depression screening, and 11 to 15 Severe Depression screening.
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Up to twelve weeks
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PSQI (Pittsburgh Sleep Quality Index)
Time Frame: Up to twelve weeks
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A simple and valid assessment of both sleep quality and disturbance that might affect.
They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score.
The higher value represents a worse result.
Higher scores indicate poorer sleep.
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Up to twelve weeks
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Chair sit and reach test
Time Frame: Up to twelve weeks
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To test low back and hamstring flexibility.
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Up to twelve weeks
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Back scratch test
Time Frame: Up to twelve weeks
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To measure general shoulder range of motion.
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Up to twelve weeks
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TMT (Trail Making Test)
Time Frame: Up to twelve weeks
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It is used to assess executive function.
It measures timed motor and visual tasks, and is divided into two tests: Part A (TMTA), which assesses speed and psychomotor attention and requires connecting consecutively numbered circles; and Part B (TMTB), which tests executive function and requires connecting alternating circles of numbers and letters.
Longer completion times indicate poor performance.
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Up to twelve weeks
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SFT (Senior Fitness Test)
Time Frame: Up to twelve weeks
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Instrument used to assess functional abilities.
It consists of the following tests: muscle strength (upper and lower limbs), aerobic endurance, flexibility (upper and lower limbs) and agility, 6-minute walk test, Sit-to-foot test using a chair (measures flexibility of the lower body, Try to clasp hands behind your back, Try to get up, walk 8 feet and sit back.
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Up to twelve weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tinetti scale
Time Frame: Up to twelve weeks
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It is used to determine early the risk of falling in an elderly person during the year following its application.
The result of both sections will be added, so that a score of less than 19 points will imply a high risk of falls, a score of 19 to 24 will reflect medium risk of falls and a score of 25 to 28 will indicate low risk of falls.
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Up to twelve weeks
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Frailty phenotype
Time Frame: Up to twelve weeks
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Five original characteristics are evaluated: involuntary weight loss, self-reported exhaustion, slow gait speed, weakness, and low physical activity.
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Up to twelve weeks
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Handgrip Strength
Time Frame: Up to twelve weeks
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Dynamometer will be employed to assess hand grip strength.
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Up to twelve weeks
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Mindful Attention Awareness Scale (MAAS)
Time Frame: Up to twelve weeks
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It evaluates, in a global way, the dispositional capacity of an individual to be attentive and aware of the experience of the present moment in everyday life.
The scale is a 15-item univariate self-report with a view of the mindfulness construct centered on the attention / consciousness variable.
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Up to twelve weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2024
Primary Completion (Actual)
January 15, 2024
Study Completion (Actual)
April 5, 2024
Study Registration Dates
First Submitted
November 8, 2023
First Submitted That Met QC Criteria
November 8, 2023
First Posted (Actual)
November 14, 2023
Study Record Updates
Last Update Posted (Actual)
April 13, 2025
Last Update Submitted That Met QC Criteria
April 9, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- -UJAEN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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