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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
198
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.
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.
University of Kansas
Lawrence, Kansas, United States
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.
Time frame: Baseline to 18 months
Sedentary Time
Sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months.
Time frame: Baseline to 18 months
Functional Fitness
Functional fitness will be measured at baseline, 6, 12 and 18 months using Functional Fitness Test (FFT) previously called the Senior Fitness Test. The individual fitness test items involve common activities such as getting up from a chair, walking, lifting, bending, and stretching.
Time frame: Baseline to 18 months
Activities of Daily Living
Activities of daily living will be assessed at baseline, 6, 12 and 18 months using the Disabilities Assessment for Dementia (DAD). The DAD includes 40 items: 17 related to basic self-care and 23 to instrumental activities of daily living. Scores range from 0-40, with higher scores indicating less disability.
Time frame: Baseline to 18 months
Change in Quality of Life
Quality of life will be assessed at baseline to 18 months using the QOL-AD, a brief, 13-item self-report and 15-item caregiver-report. Each item is rated on a scale from 1-4, 1=Poor, 2=Fair, 3=Good, 4=Excellent. Scores range from 13-52, with larger numbers indicating better quality of life.
Time frame: Baseline to 18 months
Residential Transitions
Residential transitions, i.e., from home to institutional care, will be tracked by health coaches. Caregiver desire to institutionalize the adult with AD will be assessed using the 6-item Morycz's Desire-to-Institutionalize Scale
Time frame: Baseline to 18 months
Cognitive Function
Cognitive function will be assessed at baseline, 6, 12 and 18 months using Applied Cognition Abilities 4a instruments from the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Battery. Both test contain 4 questions that will be answered by the adult with AD. Scores range from 0-100, with higher scores indicating better cognitive function.
Time frame: Baseline to 18 months
Caregiver Sedentary Time
Caregiver sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months.
Time frame: Baseline to 18 months
Caregiver Functional Fitness
Caregiver functional fitness will be measured at baseline, 6, 12 and 18 months using Functional Fitness Test (FFT) previously called the Senior Fitness Test. The individual fitness test items involve common activities such as getting up from a chair, walking, lifting, bending, and stretching.
Time frame: Baseline to 18 months
Caregiver Quality of Life
Caregiver quality of life will be assessed at baseline, 6, 12 and 18 months using the SF-36, which involves 36 questions relating to quality of life in typically developed adults. Scores range from 0-100, with higher score indicates better health.
Time frame: Baseline to 18 months
Caregiver Burden
Caregiver Burden will be assessed at baseline, 6, 12 and 18 months using the Zarit Burden Interview-short version, a 12-item self-report questionnaire in which the caregiver is asked to answer using a 5-point scale. Scores range from 0-48, with lower scores indicating less caregiver burden.
Time frame: Baseline to 18 months
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