A Dyadic Approach for a Remote Physical Activity Intervention in Adults With AD and Their Caregivers
Completed · Not applicable
Conditions studied: Alzheimer Disease
In brief
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 facts
- Study ID
- NCT04102514
- Run by
- University of Kansas
- People needed
- 198
- Starts
- 2020-07-06
- Expected to finish
- 2024-08-19
- Last updated by the study team
- 2025-06-08
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults with AD -
- Very mild to moderate dementia
- Age ≥ 55 yrs
- Low-risk of falls
- Ability to participate in MPA, e.g., walk including with an assistive device, as verified PCP clearance.
- Ability to communicate verbally.
- Vision and hearing sufficient to safely comply with the intervention program as verified by PCP clearance.
- Reside at home and receive support from a caregiver.
- Internet access in the home.
- Caregivers-
- Age ≥18 yrs.
- Spends at least 20 hrs./wk. with the adult with AD.
- Exclusion Criteria: Adults with AD-
- Current exercise, i.e., > 3, 30-min bouts of planned exercise/wk.
- Clinically significant psychiatric disorder; systemic illness or infection likely to affect safety; clinically-evident stroke; myocardial infarction or coronary artery disease in the last 2 yrs.; cancer in the last 5 yrs.; or significant pain or musculoskeletal symptoms that would prohibit exercise.
- Unwilling to be randomized.
- Caregivers-
- Unable to participate in MPA, i.e., brisk walking.
- Unwilling to be randomized.
- Serious medical risk, such as cancer within the last 5 yrs. or cardiac event, i.e., heart attack, stroke, angioplasty within the last 2 yrs.
Where it is running
- University of Kansas — Lawrence, Kansas, United States
Full record on ClinicalTrials.gov
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