- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07931469
Real-life Dual-Task Training for Older Adults at Risk to Fall: A Pilot Clinical Trial (REAL-DTT)
Older adults have difficulty optimizing two tasks at once and typically experience greater interference than younger adults when dual-tasking, meaning that there is greater decline in performance of at least one task when comparing single and dual-tasking. Difficulty dual-tasking may actually predict falls in community-dwelling older adults. Dual-task training has been shown to improve cognitive outcomes (attention, memory), motor outcomes (balance, gait), and dual-task performance in older adults; however, most dual-task training involves simulated tasks that do not reflect functional dual tasks in the real world. Greater dual-task improvements could be seen when training functionally specific tasks. One way to increase task specificity is to offer real-life, contextually-relevant, dual-task training embedded in instrumental activities of daily living (IADLs). Therefore, the purpose of this study is to assess feasibility, acceptability, and preliminary efficacy of a real-life dual-task training program for older adults at risk to fall compared to fall prevention education.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Laura A Swink, PhD
- Numer telefonu: 9704917915
- E-mail: laura.swink@colostate.edu
Lokalizacje studiów
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Colorado
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Fort Collins, Colorado, Stany Zjednoczone, 80524
- Colorado State University
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Kontakt:
- Laura Swink, PhD
- Numer telefonu: 9704917915
- E-mail: laura.swink@colostate.edu
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- ≥65 years old
- fall risk identified from one of the Centers for Disease Control STEADI Three Key Questions Screen
- ambulatory in the home with or without an assistive device
- fluent in English
Exclusion Criteria:
- clinically meaningful cognitive impairment as evidenced by Montreal Cognitive Assessment Score screening
- unstable cardiac condition (e.g., unstable angina, acute myocarditis, acute pericarditis)
- acute systemic infection
- active cancer treatment
- prisoners
- unable or unwilling to attend assessment or intervention sessions (Colorado State University)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Real-life Dual-Task Training
Six real-life dual-task training sessions with explicit focus on motor and cognitive components of instrumental activities of daily living. Training occurs with a licensed occupational therapist, and activity selection and grading is guided by the therapist and participant. |
The intervention is Real-life Dual-Task Training (Real-DTT) which uses instrumental activities of daily living training with explicit focus on the cognitive and motor elements and progressive complexity. A structured debrief is used to determine when to focus attention on cognitive vs. motor tasks in order to reduce fall risk. The Real-DTT sessions will be delivered once a week for 6 weeks and delivered by a licensed occupational therapist. Real-DTT is a modified version of occupational therapy, with a protocol tailored to the participants. |
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Aktywny komparator: Fall Prevention Education
Six guided fall prevention education sessions combining evidence-based fall prevention topics, CDC patient fall prevention handouts, NIH/NCOA fall prevention education resources, and tailored discussion utilizing behavior-change techniques. |
Guided fall prevention education combining evidence-based fall prevention topics, CDC patient fall prevention handouts, NIH/NCOA fall prevention education resources, and tailored discussion utilizing behavior-change techniques. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Cognitive Dual-Task Effect
Ramy czasowe: Baseline, week 6-7, week 12-14
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Cognitive Dual-task Effect is a percent change from single to dual-tasking: ([dual-task-singletask]/single-task) *100. The cognitive condition is verbal fluency. The dual-task condition combines verbal fluency (cognitive) through the Timed Up & Go dual task. |
Baseline, week 6-7, week 12-14
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Motor Dual-Task Effect
Ramy czasowe: Baseline, week 6-7, week 12-14
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Motor Dual-task Effect is calculated as a motor percent changes from single to dual-tasking: ([dual-task-singletask]/single-task) *100. The percent change calculates the difference in time in seconds to complete the Timed Up & Go from single to dual-task. |
Baseline, week 6-7, week 12-14
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Performance-Based Assessment of Self-Care Skills
Ramy czasowe: Baseline, week 6-7, week 12-14
|
The Performance-Based Assessment of Self-Care Skills (PASS) is a performance-based measure of activity performance. The PASS is validated for individual instrumental activities of daily living (IADLs) and therefore we will use the 14 physical emphasis IADLs, and the 4 cognitive emphasis IADLs. |
Baseline, week 6-7, week 12-14
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Activities-Specific Balance Confidence Scale
Ramy czasowe: Baseline, week 6-7, week 12-14
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A standardized 16-item self-report measure of balance confidence, scores range from 0-100% with higher scores indicating greater confidence in balance when performing various functional activities. |
Baseline, week 6-7, week 12-14
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Acceptability of Intervention Measure
Ramy czasowe: week 12-14
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The Acceptability of Intervention Measure is a self-report measure used for intervention feedback. The assessment is 4 questions in total scored 4-20 with greater scores indicating greater acceptability. |
week 12-14
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Intervention Appropriateness Measure
Ramy czasowe: week 12-14
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The Intervention Appropriateness Measure is a self-report measure used for intervention feedback. The assessment is 4 questions in total scored 4-20 with greater scores indicating greater appropriateness. |
week 12-14
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Feasibility of Intervention Measure
Ramy czasowe: week 12-14
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The Feasibility of Intervention Measure is a self-report measure used for intervention feedback. The assessment is 4 questions in total scored 4-20 with greater scores indicating greater feasibility. |
week 12-14
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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 8483
- R21AG095443 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
At the study completion, de-identified (i.e., not including name, or any identifying information) demographic data, health information data, self-reported falls data, and performance-based assessment data will be preserved to enable sharing on a repository for transparency and per NIH sharing agreements.
Ramy czasowe udostępniania IPD
Reviewed by NACDA after study completion, data de-identification, and posting. Then NACDA maintains archives permanently.
Kryteria dostępu do udostępniania IPD
NACDA's curation staff performs a reidentification risk and harm risk review of all data to ensure confidentiality is protected in released datasets. Data cleared for public access have minimal reidentification and harm risk, and therefore, no restrictions on access.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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