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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Laura A Swink, PhD
- Telefoonnummer: 9704917915
- E-mail: laura.swink@colostate.edu
Studie Locaties
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Colorado
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Fort Collins, Colorado, Verenigde Staten, 80524
- Colorado State University
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Contact:
- Laura Swink, PhD
- Telefoonnummer: 9704917915
- E-mail: laura.swink@colostate.edu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
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: 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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Actieve vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Cognitive Dual-Task Effect
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Performance-Based Assessment of Self-Care Skills
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 8483
- R21AG095443 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
Reviewed by NACDA after study completion, data de-identification, and posting. Then NACDA maintains archives permanently.
IPD-toegangscriteria voor delen
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.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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