High-Amplitude Functional Exercises in Older Adults With Mild Cognitive Impairment
9 augustus 2026 bijgewerkt door: Yunus Emre Tutuneken, Istinye University
Effects of Dual-Task-Based High-Amplitude Functional Exercises on Balance and Functional Mobility in Older Adults With Mild Cognitive Impairment
This study will investigate the effects of dual-task-based high-amplitude functional exercises on balance and functional mobility in older adults with mild cognitive impairment.
A total of 36 participants aged 65 years and older will be randomly assigned to either a high-amplitude functional exercise group or a traditional balance and mobility exercise group.
Both groups will participate in exercise sessions four times per week for four weeks, with each session lasting 60 minutes.
The effects of the exercise programs will be evaluated by assessing balance, functional mobility, dual-task performance, walking performance, fear of falling, and independence in daily activities before and after the intervention.
Studie Overzicht
Toestand
Nog niet aan het werven
Studietype
Ingrijpend
Inschrijving (Geschat)
36
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Living independently/actively in a nursing home.
- Diagnosis of Mild Cognitive Impairment (MCI) based on a standardized screening test, with a Montreal Cognitive Assessment (MoCA) score of 18-25.
- Ability to walk independently for at least 10 meters without an assistive device or with only a cane/single-point support.
- Sufficient vision and hearing capacity to follow dual-task instructions and exercise directions, which may be corrected with glasses or hearing aids.
- Stable medical condition that does not prevent participation in the exercise program throughout the study.
Exclusion Criteria:
- Diagnosis of dementia or severe cognitive impairment based on cognitive screening (MoCA <17).
- Neurological conditions that primarily affect balance, such as Parkinson's disease, residual effects of stroke, multiple sclerosis, or cerebellar ataxia.
- Severe osteoarthritis, active inflammatory joint disease, or a history of major orthopedic surgery within the previous 6 months that could limit exercise performance.
- Uncontrolled hypertension, heart failure (NYHA Class III-IV), or cardiopulmonary instability causing symptoms during exercise.
- Advanced vestibular pathology or severe loss of proprioception in the lower extremities that could be the primary cause of balance impairment.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Dual-Task-Based High-Amplitude Functional Exercise
|
Participants will receive a dual-task-based high-amplitude functional exercise program consisting of high-amplitude functional movements combined with progressively challenging cognitive tasks.
The program will be administered 4 times per week for 4 weeks, for a total of 16 sessions, with each session lasting 60 minutes.
Exercise intensity will be prescribed as maximal effort, corresponding to 7-8/10 on the Borg Rating of Perceived Exertion Scale.
The program will include seated and standing functional exercises, large-amplitude stepping movements, dynamic movements, large-amplitude walking, functional task activities, and complex functional tasks.
|
|
Actieve vergelijker: Traditional Balance and Mobility Exercise
|
Participants will receive a traditional balance and mobility exercise program administered 4 times per week for 4 weeks, for a total of 16 sessions, with each session lasting 60 minutes.
Exercise intensity will be moderate, corresponding to 4-5/10 on the Borg Rating of Perceived Exertion Scale.
The program will consist of motor tasks without cognitive dual-task components.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Dual-Task Timed Up and Go Test
Tijdsspanne: Baseline to post-intervention (4 weeks)
|
The Dual-Task TUG will assess functional mobility under cognitive load by adding a cognitive task to the standard Timed Up and Go test.
Test performance will be recorded as the time required to complete the task.
|
Baseline to post-intervention (4 weeks)
|
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Mini-BESTest
Tijdsspanne: Baseline to post-intervention (4 weeks)
|
The Mini-BESTest will be used to assess balance performance across anticipatory postural control, reactive postural control, sensory orientation, and dynamic gait.
The scale consists of 14 items scored from 0 to 2, with a maximum total score of 28.
Higher scores indicate better balance performance.
|
Baseline to post-intervention (4 weeks)
|
|
Five Times Sit-to-Stand Test
Tijdsspanne: Baseline to post-intervention (4 weeks)
|
The Five Times Sit-to-Stand Test will be used to assess lower-extremity muscle strength and functional capacity.
The time required to complete five full sit-to-stand repetitions will be recorded.
|
Baseline to post-intervention (4 weeks)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Timed Up and Go Test (TUG)
Tijdsspanne: Baseline to post-intervention (4 weeks)
|
The TUG will be used to assess functional mobility and dynamic balance.
|
Baseline to post-intervention (4 weeks)
|
|
Edinburgh Visual Gait Score
Tijdsspanne: Baseline to post-intervention (4 weeks)
|
The EVGS will be used to assess gait quality through observational analysis of gait kinematics across different anatomical segments.
|
Baseline to post-intervention (4 weeks)
|
|
Dual-Task Walking Speed
Tijdsspanne: Baseline to post-intervention (4 weeks)
|
Walking speed will be measured during a cognitive dual-task condition over a 10-meter walking course and recorded in meters per second.
|
Baseline to post-intervention (4 weeks)
|
|
Dual-Task Cost
Tijdsspanne: Baseline to post-intervention (4 weeks)
|
Dual-task cost will be calculated from the TUG performance using the formula.
|
Baseline to post-intervention (4 weeks)
|
|
Falls Efficacy Scale-International I
Tijdsspanne: Baseline to post-intervention (4 weeks)
|
The FES-I will be used to assess concerns about falling during daily activities.
Higher scores indicate greater fear of falling.
|
Baseline to post-intervention (4 weeks)
|
|
Barthel Index
Tijdsspanne: Baseline to post-intervention (4 weeks)
|
The Barthel Index will be used to assess independence in basic activities of daily living, including eating, bathing, dressing, and transfers.
Scores range from 0 to 100, with higher scores indicating greater independence.
|
Baseline to post-intervention (4 weeks)
|
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Global Change Scale
Tijdsspanne: Post-intervention (4 weeks)
|
The Global Change Scale will be used to assess participants' perceived change following the intervention.
Participants will rate perceived change from -5 (much worse) to +5 (much better).
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Post-intervention (4 weeks)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
20 augustus 2026
Primaire voltooiing (Geschat)
5 april 2027
Studie voltooiing (Geschat)
5 april 2027
Studieregistratiedata
Eerst ingediend
9 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 augustus 2026
Eerst geplaatst (Werkelijk)
13 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
9 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 104
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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