Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
376 participants
INTERVENTIONAL
2025-01-10
2028-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PACE Program
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.
PACE Program
The 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.
Waitlist Control
Participants assigned to the Waitlist Control Group will not receive any intervention during this interval. Participants will receive the PACE Program after the completion of the 16-weeks for the Intervention Group.
No interventions assigned to this group
Interventions
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PACE Program
The 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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Brianne R Tomaszewski, PhD., MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of Arkansas
Fayetteville, Arkansas, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Savage MN, Tomaszewski BT, Hume KA. Step It Up: Increasing Physical Activity for Adults With Autism Spectrum Disorder and Intellectual Disability Using Supported Self-Management and Fitbit Technology. Focus Autism Other Dev Disabl. Published online January 25, 2022:108835762110737. doi:10.1177/10883576211073700
Diaz KM. Leisure-time physical activity and all-cause mortality among adults with intellectual disability: the National Health Interview Survey. J Intellect Disabil Res. 2020 Feb;64(2):180-184. doi: 10.1111/jir.12695. Epub 2019 Dec 2.
De la Rosa A, Olaso-Gonzalez G, Arc-Chagnaud C, Millan F, Salvador-Pascual A, Garcia-Lucerga C, Blasco-Lafarga C, Garcia-Dominguez E, Carretero A, Correas AG, Vina J, Gomez-Cabrera MC. Physical exercise in the prevention and treatment of Alzheimer's disease. J Sport Health Sci. 2020 Sep;9(5):394-404. doi: 10.1016/j.jshs.2020.01.004. Epub 2020 Feb 4.
Sinai A, Bohnen I, Strydom A. Older adults with intellectual disability. Curr Opin Psychiatry. 2012 Sep;25(5):359-64. doi: 10.1097/YCO.0b013e328355ab26.
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.
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
Related Links
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Study recruitment and participant interaction website
Other Identifiers
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24-0921
Identifier Type: -
Identifier Source: org_study_id
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