Purpose: Conduct a wait-list randomized controlled trial (RCT) of an inclusive physical activity program called PACE for adults with intellectual disability (ID) who are not yet showing signs of Alzheimer's Disease (AD)/age-related dementias (ARD).
Participants: Participants include 120 adults with ID, their caregivers, and their coaches (up to 360 individual participants, grouped as triads), recruited through the University of North Carolina at Chapel Hill and the University of Arkansas. Participants also include 16 exercise professionals.
Procedures (methods): Each cohort will include 20 triads who are randomly assigned to the PACE program or the waitlist control group.
ages 18 and older with a prior clinical diagnosis of ID, confirmed by scores < 70 and + 90% on the Leiter-3 International Performance Scales and/or an adaptive behavior measure using the Vineland Adaptive Behavior Scales,
Medical clearance to participate in moderate-to-vigorous physical activity as determined by the American College of Sports Medicine (ACSM) preparticipation algorithm,
Adult does not show clinically elevated symptoms of Alzheimer's Disease (AD)/ Alzheimer's Disease and Related Dementias (ADRD) as indicated by a score of < 20 on the Dementia Screening Questionnaire for Individuals with Intellectual Disabilities.
One caregiver/guardian is able and willing to participate.
access to the internet and a mobile device,
has weekly contact with the adult participant with ID,
can converse and read in English to comprehend intervention materials and website content, and
must reside in North Carolina or Arkansas
Parallel
PACE Program
BehavioralThe PACE program is a 16-week inclusive exercise program taught and adapted by certified Inclusive Fitness Specialists. Study participants, called athletes, will engage in the fitness class with non-study participants with and without disabilities. Athlete participants will also meet weekly with their coaches (also study participants) to discuss goal setting and interact with the web-based dashboard.
Number of Steps Per Day as Measured by the ActiGraph GT9X Link
The Actigraph GT9X Links measures daily step counts. Step counts less than 2500 are classified as basal, step counts between 2500 to 4999 are classified as limited, step counts between 5000 to 7499 are classified as low, step counts between 7500-9999 are classified as somewhat active, step counts between 10000 to 12499 are classified as active, and step counts over 12500 are classified as very active.
Minutes of Moderate-to-Vigorous Activity Per Day as Measured by the ActiGraph GT9X Link
The Actigraph GT9X Links measures activity counts each minute of wear time. Each activity count over 3,941 equals 1 minute of moderate-vigorous physical activity. A total of 150 or more weekly MVPA minutes meets Physical Activity guideline recommendations.
Body Composition from Baseline as Measured by percentage of total body mass
Body composition will be assessed using the Bod Pod at University of North Carolina and the DXA at University of Arkansas. The Bod Pod is an air displacement plethysmograph that uses whole-body densitometry to determine fat, lean, and total body mass. Total body mass \>30%for men/40% for women=risky, 21- 30%for men/31-40%for women=extra fat, 13-20%for men/23-30% for women=acceptable, 9-12% for men/19 -22% for women=excellent health ), 5-8 % for men/15-18 %for women= ultra lean, and \<5 percent and \<15%=risky low body fat. The Dual-Energy X-Ray Absorptiometry (DXA) scan measures body fat percentage. Optimal body fat percentages for adults age 20-29 are 16-24%for females/7-17 % for males; age 30-39 are 17-25% for females/12-21% for males, age 40-49 are 19-28% for females/14-23% for males, ages 50-59 are 22-31% for females/16-24% for males, age 60+ are 22-33% for females/17-25% for males. Numbers that are higher than optimal=overweight and lower than optimal=underweight.
Wellbeing from Baseline as Measured by the World Health Organization Quality of Life Assessment and Disabilities Module
Adults with intellectual disability (ID) will complete the World Health Organization Quality of Life Assessment and World Health Organization Disabilities Module measures of quality of life. The WHOQoL-BREF and WHO Disabilities module is an abbreviated 39-item version of the original WHOQOL tool that has been used in adults with ID. The domain scores will be used to measure the general quality of life (Overall, Health, Physical, Psychological, Social, Environment, and Disabilities Module). Scores Range from 0-100 with higher scores indicating better quality of life.
Daily Living Skills from Baseline as Measured by the Waisman Activities of Daily Living Scale
Activities of daily living will be measured using caregiver-report using the Waisman Activities of Daily Living (W-ADL). The 17-item W-ADL measures the level of independence in performing typical daily activities for adolescents and adults. The W-ADL has demonstrated high internal consistency (Cronbach alphas= .88-.94) and reliability over time (Kappas= .92-.93) in adults with intellectual disability. Performance is rated on a 3-point scale (0 means the participant does not do the activity at all, 1 means the participant does the activity with help, and 2 means the participant does the activity independently). The scoring range is 0 to 34 with higher scores signifying greater independence in daily living activities.
Mental and Cognitive Functioning from Baseline as Measured by the NIH-Toolbox Cognitive Battery
Mental and cognitive functioning will be measured using the NIH-Toolbox Cognitive Battery (NIHTB-CB), which has been validated in individuals with intellectual disability and adults across the spectrum of Alzheimer's disease and age-related cognitive decline. The NIHTB-CB is an iPad-based assessment of memory, executive function, and crystallized intelligence. The Fluid Cognition Composite includes fluid ability measures: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. The Crystallized Cognition Composite Score includes the Picture Vocabulary and Reading Tests. The composite scores are derived by averaging the standard scores of each of the measures. Higher scores indicate higher levels of functioning - a score at/near 100 indicates ability that is average compared with others nationally, 115 suggests above-average, 130 suggests superior ability, 85 suggests significantly below-average, and a score of below suggests very low.
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University of North Carolina, Chapel Hill
Lead sponsor
National Institute on Aging (NIA)
Collaborator
