A Dyadic Approach for a Remote Physical Activity Intervention in Adults With AD and Their Caregivers

Part of paid clinical trials in Lawrence, Kansas.

Sponsor
University of Kansas
Study ID
NCT04102514
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Real-time Group Video — BEHAVIORAL
    Dyads in the RGV arm will be asked to complete three 45 min sessions that include aerobic, resistance, and balance/coordination exercises delivered by a trained health coach via Zoom® software on an iPad during mos. 0-6, and 1 session/wk. during mos. 7-12 to groups of 5-8 dyads in their home along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA.
  • Enhanced Usual Care — BEHAVIORAL
    Dyads in the EUC arm, will be given a recommended exercise plan to follow on their own along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA.

Study Details

The objective of this study is to compare the effectiveness of 2 intervention delivery strategies for increasing moderate physical activity (MPA), real-time group video conferencing (RGV) vs. enhanced usual care (EUC), in community dwelling adults with Alzheimer's diseases (AD) and their caregiver (dyads) over 18 mos. (6 mos. active, 6 mos. maintenance, 6 mos. no contact). The primary outcome is to compare total MPA (min/wk.), assessed using ActiGraph, in adults with AD from baseline to 6 mos. Secondary aims for the Adults with AD are to compare MPA (min/wk), sedentary time (min/wk.), percentage meeting 150 min/wk. goal, functional fitness, activities of daily living (basic/instrumental), quality of life, residential transitions, and cognitive function across 18 months between RGV and EUC. Secondary aims for the caregivers are to compare total MPA (min/wk.), sedentary time (min/wk.), functional fitness, quality of life, caregiver burden across 18 months between RGV and EUC. Additionally, as an exploratory aim, this study will evaluate the influence of process variables/participant characteristics on MPA in adults with AD and their caregiver across 6, 12 \& 18 mos.: age, sex, BMI, attendance (exercise/support sessions), use of recorded videos, PA self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers.

Key Dates

Start date
Jul 6, 2020
Status verified
Aug 2024
Primary completion
Aug 19, 2024
Completion
Aug 19, 2024

Study Design

Enrollment
198 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Other: Real-time Group Video
  • Other: Enhanced Usual Care

Primary Outcome Measure

Moderate Physical Activity [ Time Frame: Baseline to 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of KansasLawrenceKansas66045-

Find similar trials in Lawrence, KS

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of Kansas· Lawrence, KS

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