NCT06479694

Brief Summary

Older adults have difficulty optimizing two tasks at once and typically experience greater interference than younger adults when dual-tasking, meaningful 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). Limited evidence exists for dual-task training interventions for older adults with T2DM; however there is early evidence of improvements in cognitive and motor effects with simulated dual-task training, which could translate to improved dual-task performance, reduced impact on everyday life, and reduced fall risk. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Jul 2024Jul 2026

First Submitted

Initial submission to the registry

June 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

July 3, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

June 24, 2024

Last Update Submit

May 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dual-Task Impact on Daily-living Activities Questionnaire

    The Dual-Task Impact on Daily-living Activities Questionnaire is a 19 question self-report assessment with scoring from 0-76. Higher scores indicate greater dual-task inference during daily activities.

    baseline, pre-intervention and immediately after the intervention

Secondary Outcomes (4)

  • Acceptability, Appropriateness, Feasibility

    immediately after intervention

  • Dual-Task Performance

    baseline, pre-intervention and immediately after the intervention

  • Frenchay Activities Index

    baseline, pre-intervention and immediately after the intervention

  • Self-reported Falls

    baseline, pre-intervention and immediately after the intervention

Study Arms (1)

Real-life Dual-Task Training

EXPERIMENTAL

Ten 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.

Behavioral: Real-life Dual-Task Training

Interventions

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 when to focus attention to one vs. the other to reduce fall risk. The Real-DTT sessions will be delivered once a week for 10 weeks during their occupational therapy sessions, delivered by a licensed occupational therapist. Real-DTT is a modified version of occupational therapy, with a protocol tailored to the participants.

Real-life Dual-Task Training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • at least 65 years old
  • ambulatory around the home with or without an assistive device
  • answered yes to at least one of the fall risk questions with their therapist
  • scheduled to receive occupational therapy services with instrumental activity of daily living goals through Covell Care.

You may not qualify if:

  • Not fluent in English
  • Self-reported diagnosis of dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80524, United States

RECRUITING

Central Study Contacts

Laura A Swink, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 28, 2024

Study Start

July 3, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations