High-Amplitude Functional Exercises in Older Adults With Mild Cognitive Impairment
9. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Studientyp
Interventionell
Einschreibung (Geschätzt)
36
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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.
|
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Dual-Task Timed Up and Go Test
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Timed Up and Go Test (TUG)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
|
Global Change Scale
Zeitfenster: 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).
|
Post-intervention (4 weeks)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
20. August 2026
Primärer Abschluss (Geschätzt)
5. April 2027
Studienabschluss (Geschätzt)
5. April 2027
Studienanmeldedaten
Zuerst eingereicht
9. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. August 2026
Zuerst gepostet (Tatsächlich)
13. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 104
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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