N/A
N=198
A Dyadic Approach for a Remote Physical Activity Intervention in Adults With AD and Their Caregivers
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT04102514 ↗Enrolled (actual)
198
Serious AEs
11.6%
Results posted
Jun 2025
Primary outcome: Primary: Moderate Physical Activity — 13.3; 20.7; 14.4; 19.3 minutes per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Real-time Group Video (Behavioral); Enhanced Usual Care (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- University of Kansas
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Moderate Physical Activity |
13.3; 20.7; 14.4; 19.3; 14.7; 25.1 | — |
| SECONDARY Sedentary Time |
524.8; 590.1; 532.1; 577.2; 552.5; 601.4 | — |
| SECONDARY Functional Fitness |
66.8; 59.4; 76.9; 62.2; 74.9; 66.7 | — |
| SECONDARY Activities of Daily Living |
34.0; 30.8; 31.3; 28.7; 28.2; 29.3 | — |
| SECONDARY Change in Quality of Life |
37.59; 38.61; 38.83; 38.75; 37.93; 38.81 | — |
| SECONDARY Residential Transitions |
0; 0; 2; 3; 5; 3 | — |
| SECONDARY Cognitive Function |
38.6; 41.9; 27.3; 34.7; 31.8; 34.9 | — |
| SECONDARY Caregiver Sedentary Time |
525.1; 526.9; 518.7; 526.0; 521.2; 542.1 | — |
| SECONDARY Caregiver Functional Fitness |
80.2; 80.0; 94.7; 84.3; 93.9; 87.1 | — |
| SECONDARY Caregiver Quality of Life |
36.4; 37.0; 36.4; 36.3; 36.6; 37.9 | — |
| SECONDARY Caregiver Burden |
1.75; 1.49; 1.5; 1.53; 1.53; 1.52 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04102514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.