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

NCT04102514 | Completed Results

• 2 other identifiers: STUDY00144595R01AG061187
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease

Keywords

Physical Activity; Exercise

Outcome Measures

Primary Outcomes (1)

• Moderate Physical Activity

  Moderate physical activity will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 3, 6, 12 and 18 months. The ActiGraph wGT3x-BT is worn on a belt on the non-dominant hip during all waking hours for one week (7 consecutive days), with the exception of bathing, and swimming. The device measures acceleration. The acceleration values are used to determine levels of physical activity using previously validated cutpoints. Data were considered valid if they wore the accelerometer for at least 8 hours on 3 days, including 1 weekend day.

  Baseline to 18 months

Secondary Outcomes (10)

• Sedentary Time

  Baseline to 18 months

• Functional Fitness

  Baseline to 18 months

• Activities of Daily Living

  Baseline to 18 months

• Change in Quality of Life

  Baseline to 18 months

• Residential Transitions

  Baseline to 18 months

Other Outcomes (7)

• Body Mass Index

  Baseline to 18 months

• Session Attendance

  Baseline to 18 months

• Use of Recorded Videos

  Baseline to 18 months

Study Arms (2)

Real-time Group Video

OTHER

Behavioral: Real-time Group Video

Enhanced Usual Care

OTHER

Behavioral: Enhanced Usual Care

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.

Real-time Group Video

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Kansas

Lawrence, Kansas, 66045, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Motor Activity

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Lauren Ptomey
• Organization: University of Kansas Medical Center

lptomey@kumc.edu

913-588-7983

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: July 6, 2020
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)