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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Laura A Swink, PhD
- Telefonní číslo: 9704917915
- E-mail: laura.swink@colostate.edu
Studijní místa
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Colorado
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Fort Collins, Colorado, Spojené státy, 80524
- Colorado State University
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Kontakt:
- Laura Swink, PhD
- Telefonní číslo: 9704917915
- E-mail: laura.swink@colostate.edu
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Cognitive Dual-Task Effect
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Performance-Based Assessment of Self-Care Skills
Časové okno: Baseline, week 6-7, week 12-14
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 8483
- R21AG095443 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Časový rámec sdílení IPD
Reviewed by NACDA after study completion, data de-identification, and posting. Then NACDA maintains archives permanently.
Kritéria přístupu pro sdílení 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 podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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