Clinical trial NCT06740162: Physical Activity and Community EmPOWERment Project
Official title: A Stage 1 Pilot Test for Feasibility and Efficacy of a Multi-Level Intervention to Increase Physical Activity in Adults With Intellectual Disability: Physical Activity and Community EmPOWERment (PACE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intellectual Disability
Neurodevelopmental Disorders
Autism Spectrum Disorder
Down Syndrome
Fragile X Syndrome
Cri-du-Chat Syndrome
De Lange Syndrome
Mental Retardation, X-Linked
Prader-Willi Syndrome
Rubinstein-Taybi Syndrome
Trisomy 13 Syndrome
WAGR Syndrome
Williams Syndrome
Keywords: physical activity
intellectual disability
age-associated memory impairment
aging
Alzheimer Disease prevention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-12-18
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Each potential adult with ID or family who contacts the research team will be called and screened for eligibility in the study. To determine eligibility, screening questions will include asking if the adult participant has a formal diagnosis of ID; report of intellectual ability level will be confirmed with direct cognitive testing during the screening assessment visit using scales completed by the participant and caregiver. Also at the screening visit, caregivers will complete the dementia screener for the participants, and participants will be provided with an Actigraph GT9X Link device so they can complete a weeklong physical activity baseline measure. At the second study visit, participants and caregivers will complete the pre-assessments (described below and attached), and participants will have their body composition measured. Questions to all scorable assessments will be required to prevent missing data. Select demographic information will have an additional "prefer not to answer" choice. Participants will complete demographic measures, primary and secondary outcome measures, and feasibility and acceptability measures across the first two study visits. Those who qualify will be randomly assigned to one of two conditions: (1) initial intervention or (2) waitlist control. Individuals assigned to the waitlist control group will begin the intervention after the initial group completes post-assessments.

The 16-week intervention includes: (1) a weekly group fitness class for adults with ID, (2) web based training and resources for coaches and exercise professionals; (3) weekly coaching meetings for coaches and adults with ID, and (4) daily/weekly interactions with the PACE interactive web based dashboard for adults with ID.

A post-assessment visit will be conducted to repeat the pre-assessment measures, and a subset of participants and coaches will also complete an interview to answer open-ended questions about their program experiences. A 12-month follow-up visit will also be scheduled to measure body composition again.

Brief description of measures to be completed by Caregivers as follows:

Vineland Adaptive Behavior Scales-3: (VABS) (Vineland-3) is a standardized assessment tool that utilizes semi-structured interview to measure adaptive behavior and support the diagnosis of intellectual and developmental disabilities, autism, and developmental delays. Interviews are expected to take 1-2 hours and will take place during the screening visit.

National Task Group-Early Detection Screen for Dementia: (NTG-EDSD) This measure was adapted from the Dementia Screening Questionnaire for Individuals with Intellectual Disabilities (DSQIID) and can be used for the early detection screening of those adults with an intellectual disability who are suspected of or may be showing early signs of mild cognitive impairment or dementia. The NTG-EDSD is not an assessment or diagnostic instrument, but an administrative screen that can be used by staff and family caregivers to note functional decline and health problems and record information useful for further assessment. This assessment will take place during the screening visit.

Add Health Wave 5 Questionnaire: Questions will be used from the Wave 5 Survey including questions on background (biological sex, gender, race/ethnicity), health and health care (co-occurring conditions and medical treatments, illness and physical limitations, and fitness tracking (experiences using fitness tracking devices, current exercise habits). This measure will take place during the pre and post study visits.

Waisman Activities of Daily Living (W-ADL): The W-ADL is a caregiver-report that measures activities of daily living and assesses functioning. It has demonstrated high internal consistency (Cronbach alphas= .88-.94) and reliability over time (Kappas= .92-.93) in adults with ID. This measure will take place during the pre and post study visits.

Brief description of adult with ID measures as follows:

The Leiter-3: is a widely used nonverbal measure of intelligence and cognitive abilities that is suitable to use for individuals with cognitive delays, speech or hearing problems, Attention Deficit Hyperactivity Disorder (ADHD), or traumatic brain injury. The battery subtest scores are converted to a scaled score and the sum of the scaled scores yields a nonverbal intelligence quotient (IQ)/composite score. This assessment will take place during the screening visit.

World Health Organization Quality of Life Brief Version Assessment (WHOQoL-BREF and WHO Disabilities Module): 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). This measure will take place during the pre and post study visits.

NIH-Toolbox Cognitive Battery (NIHTB-CB): The NIHTB-CB will measure mental and cognitive functioning. It has been validated in individuals with ID and adults across the spectrum of Alzheimer's disease and age-related cognitive decline. It is an iPad-based assessment of memory, executive function, and crystallized intelligence. This measure will take place during the pre and post study visits.

NIH-Toolbox Emotional Battery: The NIHTB-EB will measure emotional health across several domains: Psychological Well-Being, Social Relationships, Stress and Self-Efficacy, and Negative Affect. This is an iPad-based assessment that will take place during the pre and post study visits.

Physical Activity Measures: These measures will take place during the pre and post study visits.

Grip strength (NIH Toolbox): This test consists of squeezing the hand dynamometer for a 1-rep max strength assessment.

The 4-Stage Balance Test: This test consists of four standing positions that are progressively harder to maintain.

30-Second Chair Stand: This test consists of participants getting up from a chair without using their arms. They get up and sit down repeatedly for 30 seconds. Their score is the number of times they can get up from the chair

Timed Up \& Go (TUG): This test consists of participants getting up from a chair, walking 10 feet across the room around a cone, and sitting back down.

2-Minute Walk Endurance: This test consists of participants walking as fast as they can for two-minutes up and down the hallway of the assessment spaces.

Bod Pod: This scan will measure body composition using Air Displacement Plethysmograph (ADP). Participants at the University of North Carolina site will be briefed on the Bod Pod and sit inside for up to 5 minutes. This measure will take place during the pre- and post-study visits, as well as the one-year follow-up visit.

DXA Scan: This scan will measure body composition using dual energy X-ray absorptiometry. Participants at the University of Arkansas site will be briefed and lay on the DXA scan table for around 15 minutes. This measure will take place during the pre- and post-study visits, as well as the one-year follow-up visit. Participants who are pregnant, think they may be pregnant, or have had unprotected sex in the last 30 days will not receive a DXA scan.

Eligibility criteria: Inclusion criteria for adults with ID will include:

* 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.
* must tolerate at least 8 hours of daily wear-time of Actigraph device during initial assessment period (4 of 7 days),
* must average 20 minutes or less of moderate to vigorous physical activity (MVPA) minutes per day (140 MVPA minutes or less across 7-day period measured during the initial assessment period, and
* must reside in North Carolina or Arkansas.

Exclusion Criteria for adults with ID:

• Diagnosis of AD, dementia, or related disorders. Participants will not be excluded based on gender, race, or ethnicity. There will be no upper age limit due to the heterogeneity of onset of AD/ADRD in individuals with ID.

Inclusion criteria for coach will include:

* 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

Inclusion criteria for caregiver will include:

* ability to converse and read in English to comprehend and answer interview questions, (2) must care for an adult with ID who is willing to participate in the study,
* must reside in North Carolina or Arkansas, and
* must attend all study visits with adult with ID.

Primary outcomes:
measure: Number of Steps Per Day as Measured by the ActiGraph GT9X Link
timeFrame: Baseline, post-intervention (16 weeks)
measure: Minutes of Moderate-to-Vigorous Activity Per Day as Measured by the ActiGraph GT9X Link
timeFrame: Baseline, post-intervention (16 weeks)
Secondary outcomes:
measure: Body Composition from Baseline as Measured by percentage of total body mass
timeFrame: Baseline, post-intervention (16 weeks), Follow-up (74 weeks)
measure: Wellbeing from Baseline as Measured by the World Health Organization Quality of Life Assessment and Disabilities Module
timeFrame: Baseline, post-intervention (16 weeks)
measure: Daily Living Skills from Baseline as Measured by the Waisman Activities of Daily Living Scale
timeFrame: Baseline, post-intervention (16 weeks)
measure: Mental and Cognitive Functioning from Baseline as Measured by the NIH-Toolbox Cognitive Battery
timeFrame: Baseline, post-intervention (16 weeks)
measure: Psychological Well-Being, and Social Relationships from Baseline as Measured by the NIH Toolbox Emotion Battery
timeFrame: Baseline, post-intervention (16 weeks)
measure: Stress and Self-Efficacy, and Negative Affect from Baseline as Measured by the NIH Toolbox Emotion Battery
timeFrame: Baseline, post-intervention (16 weeks)
measure: Grip Strength from Baseline as Measured by the Hand Dynamometer
timeFrame: Baseline, post-intervention (16 weeks)
measure: Ability to Maintain Balance from Baseline as Measured by the 4-Stage Balance Test
timeFrame: Baseline, post-intervention (16 weeks)
measure: Functional Lower Extremity Strength and Endurance from Baseline as Measured by the 30-Second Chair Stand
timeFrame: Baseline, post-intervention (16 weeks)
measure: Mobility from Baseline as Measured by the Timed Up & Go (TUG)
timeFrame: Baseline, post-intervention (16 weeks)
measure: Endurance from Baseline as Measured by the 2-Minute Walk Endurance Test
timeFrame: Baseline, post-intervention (16 weeks)
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Brianne R Tomaszewski, PhD., MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Shooshtari S, Martens PJ, Burchill CA, Dik N, Naghipur S. Prevalence of Depression and Dementia among Adults with Developmental Disabilities in Manitoba, Canada. Int J Family Med. 2011;2011:319574. doi: 10.1155/2011/319574. Epub 2011 Aug 8.
citation: McCallion P, McCarron M. Ageing and intellectual disabilities: a review of recent literature. Curr Opin Psychiatry. 2004;17(5):349-352. doi:10.1097/01.yco.0000139968.14695.95