Physical Activity Program for Intellectual Disability

(PACE Trial)

Recruiting at 1 trial location

Overseen By Kara Hume, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Alzheimer's, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

376 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the benefits of a physical activity program called PACE for adults with intellectual disabilities. Researchers seek to understand how this program affects health and daily living, particularly for those not yet showing signs of Alzheimer's or related dementias. Participants will either join the PACE program, which includes fitness classes and online coaching, or be placed on a waitlist to join later. Ideal candidates are adults with intellectual disabilities residing in North Carolina or Arkansas, who currently engage in less than 20 minutes of moderate to vigorous physical activity per day. As an unphased study, this trial provides a unique opportunity to enhance health and daily living through increased physical activity.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the PACE Program is safe for adults with intellectual disability?

Research has shown that the PACE Program is under study to determine any side effects for adults with intellectual disabilities. Currently, there is no clear information about side effects from the program itself. However, the trial's "Not Applicable" phase designation suggests that the program is likely considered low-risk. Typically, physical activity programs like PACE are regarded as safe and well-tolerated, as they emphasize exercise and healthy habits.

In summary, while specific information about side effects is not yet available, similar programs are generally safe and present few issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PACE Program for people with intellectual disabilities because it offers a comprehensive and interactive approach to promoting physical activity. Unlike traditional exercise programs that might not be tailored to individuals with intellectual disabilities, PACE includes a 16-week intervention with weekly group fitness classes, web-based training, and resources specifically for coaches and exercise professionals. Additionally, it features regular coaching meetings and an interactive web-based dashboard for continuous engagement, making it more personalized and accessible. This innovative approach could significantly enhance fitness and well-being in a population that often lacks tailored physical activity opportunities.

What evidence suggests that the PACE Program is effective for adults with intellectual disability?

Research has shown that exercise programs like PACE, which participants in this trial may receive, can benefit people with intellectual disabilities (ID). One study found that a video-based exercise program improved physical abilities and balance in just 8 weeks. The PACE program includes group fitness classes and online resources to support adults with ID. These inclusive fitness programs aim to boost overall health by encouraging regular exercise. Although specific data on PACE remains limited, similar programs have demonstrated positive results, suggesting it might enhance fitness and quality of life for people with ID. ^{1 6 7 8 9}

Who Is on the Research Team?

Brianne R Tomaszewski, PhD., MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for adults with intellectual disabilities like Down Syndrome, Autism Spectrum Disorder, and several others. They should not show signs of Alzheimer's or age-related dementias. Participants will be grouped with their caregivers and coaches.

Inclusion Criteria

I do not have severe symptoms of Alzheimer's or related dementias.

One caregiver/guardian is able and willing to participate

Must reside in North Carolina or Arkansas

Exclusion Criteria

I have been diagnosed with Alzheimer's disease, dementia, or a similar condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

2 visits (in-person)

Pre-assessment

Participants and caregivers complete pre-assessments, including body composition measurements and cognitive testing

1 week

1 visit (in-person)

Treatment

Participants engage in a 16-week intervention including weekly group fitness classes, web-based training, and coaching meetings

16 weeks

Weekly visits (in-person and virtual)

Post-assessment

Post-assessment measures are conducted to evaluate the outcomes of the intervention

1 week

1 visit (in-person)

Follow-up

Participants are monitored for long-term outcomes, including body composition and cognitive assessments

12 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PACE Program

Trial Overview The PACE Program, an inclusive physical activity program, is being tested through a wait-list randomized controlled trial to see if it benefits adults with intellectual disability who don't have dementia.

How Is the Trial Designed?

Group I: PACE Program Experimental Treatment 1 Intervention

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.

Group II: Waitlist Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A systematic review of 11 studies focused on promoting physical activity among youth with intellectual disabilities found that nine of these studies reported significant increases in physical activity behavior.

However, the review could not determine which specific components of the interventions were most effective or whether the increases in activity could be sustained over the long term, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to promote physical activity for youth with intellectual disabilities. Frey, GC., Temple, VA., Stanish, HI.[2020]

Long-term participation in a physical activity program led to an increase in moderate to vigorous activity levels among adults with mild intellectual disability, indicating improved physical engagement over time.

Participants reported significant psychosocial benefits, such as social interaction and recognition, highlighting the positive impact of sustained physical activity on their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An initial evaluation of a long-term, sustainable, integrated community-based physical activity program for adults with intellectual disability. Lante, KA., Walkley, JW., Gamble, M., et al.[2011]

Interventions aimed at increasing physical activity (PA) levels in adults with intellectual disabilities show potential benefits for their health and wellbeing, but the quality of the studies reviewed was generally poor, with small sample sizes and unreliable measurement tools.

Only six studies met the criteria for inclusion, indicating a need for more robust research in this area to effectively address the health inequities faced by adults with intellectual disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of interventions aiming to improve involvement in physical activity among adults with intellectual disability. Brooker, K., van Dooren, K., McPherson, L., et al.[2018]

A review of 40 trials involving individuals with psychological or cognitive conditions found a relatively low prevalence of adverse events related to physical activity, suggesting that exercise is generally safe for these populations.

However, caution is advised for individuals with Down syndrome due to the risk of atlantoaxial instability, indicating that specific screening may be necessary before engaging in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: cognitive and psychological conditions. Rhodes, RE., Temple, VA., Tuokko, HA.[2016]

An 8-month physical activity program for older adults with intellectual disabilities showed significant improvements in physical activity levels, muscle strength, blood pressure, cholesterol levels, and cognitive functioning among 81 participants compared to a control group of 70.

Despite these positive outcomes, the program did not lead to significant improvements in balance, glucose levels, weight, mobility, or depression, and participant dropout was a concern, suggesting the need for further research and careful implementation in different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A structured physical activity and fitness programme for older adults with intellectual disabilities: results of a cluster-randomised clinical trial. van Schijndel-Speet, M., Evenhuis, HM., van Wijck, R., et al.[2019]

This systematic review aims to evaluate the benefits of exercise on various fitness components in adults with intellectual disabilities (ID), highlighting the importance of physical activity for improving health and quality of life in this population.

The review will include systematic studies that compare exercise interventions to control groups, focusing on objective measures of fitness, which could help develop tailored exercise programs to enhance fitness levels in adults with ID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on fitness in adults with intellectual disability: a protocol of an overview of systematic reviews. Simón-Siles, S., Font-Farré, M., Guerra-Balic, M., et al.[2022]

A systematic review of six studies focused on promoting physical activity among adults with intellectual disabilities found that three of these studies successfully increased physical activity levels.

However, interventions aimed at improving weight status through increased physical activity did not show significant results, suggesting that both individual and environmental factors need to be addressed for effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to promote physical activity for adults with intellectual disabilities. Temple, VA., Frey, GC., Stanish, HI.[2020]

A systematic review identified 5 studies focused on promoting physical activity among adults with intellectual disabilities, utilizing various strategies across different levels of influence, including individual and community approaches.

The review provides recommendations for researchers and practitioners to effectively increase physical activity levels in this population, emphasizing the need for tailored interventions that consider the unique challenges faced by individuals with intellectual disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity promotion and adults with intellectual disabilities: A neglected area. MacDonald, C., Bush, PL., Foley, JT.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11111989/

The effectiveness of video-based exercise training program for ... A specially designed video-based exercise program has demonstrated some positive effects on physical and balance performance after 8 weeks of training.

2. withpower.com withpower.com/trial/phase-rubinstein-taybi-syndrome-11-2024-71f30

Physical Activity Program for Intellectual Disability What data supports the effectiveness of the PACE Program treatment for individuals with intellectual disabilities? ... effective outcomes. NCBI (Pubmed). pubmed.

3. ed.unc.edu ed.unc.edu/2023/07/12/understanding-the-benefits-of-inclusive-fitness/

Understanding the benefits of inclusive fitness The PACE program builds upon a 16-week at-home walking program for adults with intellectual disabilities called Step It Up, providing them with ...

4. nature.com nature.com/articles/s41598-022-26024-1

Effectiveness of an adapted physical activity intervention ... It has been reported consistently that children and adolescents with intellectual disability (ID) performed much poorer in HRPF assessments, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4194541/

Stability of Disability Among PACE Enrollees Our findings indicate that mature programs experience stable disability mix over time, supporting the rationale for the current PACE payment method. However, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4587575/

Effectiveness of a walking programme to support adults with ... Programs to change health behaviours have been identified as one way to reduce health inequalities experienced by disadvantaged groups.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jir.12447

Quality improvement of physical health monitoring for ... An intellectual disability outcomes framework for improving the quality of services for people with intellectual disability. Retrieved from.

8. cms.gov cms.gov/files/document/pace-quality-monitoring-and-reporting-guidancejanuary-2024.pdf

PACE Quality Data Monitoring & Reporting Guidance ... This document provides an overview of the Programs of All Inclusive Care for the Elderly (PACE) quality monitoring and reporting requirements outlined in ...

9. valueinhealthjournal.com valueinhealthjournal.com/article/S1098-3015(24)02405-7/fulltext

A Rapid Evidence Synthesis of Tools and Methods This review aimed to identify and synthesize measurement tools and approaches that have been used to gather patient-reported experience data from people with ...