NCT04102514Completed
A Dyadic Approach for a Remote Physical Activity Intervention in Adults With AD and Their Caregivers
Source: ClinicalTrials.gov · Last updated 8 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 198 (actual)
- First submitted
- 23 Sept 2019
- Start date
- 6 Jul 2020
- Primary completion date
- 19 Aug 2024
- Lead sponsor
- University of Kansas
- Diseases
- Alzheimer disease
- NCT number
- NCT04102514
What you commit to
- Study type: Interventional
- Participants enrolled: 198
- From 6 Jul 2020 to the primary completion date, 19 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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.
Other
- Current exercise, i.e., \> 3, 30-min bouts of planned exercise/wk.
- Unwilling to be randomized.
- Caregivers-
- Unable to participate in MPA, i.e., brisk walking.
- Unwilling to be randomized.
Who the study is looking for
- 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.
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kansas Coordinator of this site? Confirm its status | Lawrence | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.