Clinical trial NCT04102514: A Dyadic Approach for a Remote Physical Activity Intervention in Adults With AD and Their Caregivers
Official title: A Dyadic Approach for a Remote Physical Activity Intervention in Adults With AD and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Physical Activity
Exercise
Lead sponsor: University of Kansas
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-09-25
Enrollment: 198
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This study will compare 2 strategies for the delivery of an intervention to increase moderate physical activity (MPA) in community dwelling adults with AD and their caregiver (dyads); real-time group video conferencing (RGV) vs. enchanced usual care (EUC). Adults (age ≥ 55 yrs.) with mild to moderate AD (n=100) and their caregiver (n=100) will be randomized (1:1) to one of the 2 intervention arms for an 18-mo. trial (6 mos. active intervention, 6 mos. maintenance, 6 mos no contact). Cohorts of \~20 dyads will be recruited and computer randomized. Dyads will be stratified by the sex of the person with AD, and sequentially randomized by the study statistician with equal allocation to the RGV or EUC arms. Participants in both arms will be provided with an iPad® for intervention delivery, Fitbit (Fitbit Inc., San Francisco, CA) for self-monitoring MPA, and will be asked to complete 150 min of MPA/wk. 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. Dyads in the EUC arm, will be given a recommended exercise plan to follow own their own. Dyads in both arms will be provided with written materials regarding exercise and physical activity from the National Institute on Aging and will be asked to complete 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. All outcomes will be collected by trained research assistants who are blinded to the study condition. The primary outcome, total MPA, will be assessed, in both individuals with AD and caregivers, by Actigraph at baseline, 3, 6, 12 \& 18 mos. All secondary/exploratory outcomes will be assessed at the individual with AD or caregivers' home at baselines, 6, 12, and 18 months. Secondary outcomes for the individual with AD are sedentary time, functional fitness, activities of daily living, quality of life, residential transition, and cognitive function. Secondary outcomes for the caregiver are sedentary time, functional fitness, quality of life, and caregiver burden. The exploratory outcomes are age, sex, BMI, attendance (exercise/support sessions), use of pre-recorded videos, PA self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers. This trial is powered to detect a between-arm difference (RGV vs. EUC) of 10 min./d. in MPA. This difference represents additional 70 mins. of MPA/wk. in the RGV arm. Power analysis shows that 84 participants (42/arm) would provide 81% power to test an overall between-arm difference across time, i.e., group effect. This sample size would also provide ≥ 80% power to detect a between-arm difference in change, i.e., group-by-time interaction, as small as f = 0.10. Thus, conservatively assuming a high attrition rate of 20%, the study team will recruit 100 dyads at baseline to assure the final sample size requirements are achieved, i.e., final N ≥ 84 (thus, power ≥ 80%) with attrition up to 20%. General mixed modeling for repeated measures will be utilized to evaluate the primary aim to compare total MPA (min/wk.) across the 6 mo. active intervention in adults with AD and their caregiver randomized to the RGV and EUC interventions. A similar mixed modeling analysis will be conducted to examine the secondary aim. General mixed models will be fitted for the two arms combined to examine the association for the process variables/participant characteristics with MPA. However, if there is a significant between-arm difference in MPA, the investigators will determine whether the process variables/participant characteristics amplify or attenuate the RGV effect, i.e., moderation, by testing a 2-way interaction with the group effect and/or a 3-way interaction with the group-by-time interaction term.

Eligibility criteria: Inclusion Criteria:

Adults with AD -

1. Very mild to moderate dementia
2. Age ≥ 55 yrs
3. Low-risk of falls
4. Ability to participate in MPA, e.g., walk including with an assistive device, as verified PCP clearance.
5. Ability to communicate verbally.
6. Vision and hearing sufficient to safely comply with the intervention program as verified by PCP clearance.
7. Reside at home and receive support from a caregiver.
8. Internet access in the home.

Caregivers-

1. Age ≥18 yrs.
2. Spends at least 20 hrs./wk. with the adult with AD.

Exclusion Criteria: Adults with AD-

1. Current exercise, i.e., \> 3, 30-min bouts of planned exercise/wk.
2. 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.
3. Unwilling to be randomized.

Caregivers-

1. Unable to participate in MPA, i.e., brisk walking.
2. Unwilling to be randomized.
3. 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.

Primary outcomes:
measure: Moderate Physical Activity
timeFrame: Baseline to 18 months
Secondary outcomes:
measure: Sedentary Time
timeFrame: Baseline to 18 months
measure: Functional Fitness
timeFrame: Baseline to 18 months
measure: Activities of Daily Living
timeFrame: Baseline to 18 months
measure: Change in Quality of Life
timeFrame: Baseline to 18 months
measure: Residential Transitions
timeFrame: Baseline to 18 months
measure: Cognitive Function
timeFrame: Baseline to 18 months
measure: Caregiver Sedentary Time
timeFrame: Baseline to 18 months
measure: Caregiver Functional Fitness
timeFrame: Baseline to 18 months
measure: Caregiver Quality of Life
timeFrame: Baseline to 18 months
measure: Caregiver Burden
timeFrame: Baseline to 18 months
Other outcomes:
measure: Body Mass Index
timeFrame: Baseline to 18 months
measure: Session Attendance
timeFrame: Baseline to 18 months
measure: Use of Recorded Videos
timeFrame: Baseline to 18 months
measure: Self-monitoring of Physical Activity
timeFrame: Baseline to 18 months
measure: Caregiver Support
timeFrame: Baseline to 18 months
measure: Peer Interactions (RGV Only)
timeFrame: Baseline to 18 months
measure: Quality of the Dyadic Relationship
timeFrame: Baseline to 18 months
Locations:
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
Study officials:
References: