Physical Activity Program for Intellectual Disability

(PACE Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Brianne R Tomaszewski, PhD., MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Alzheimer's, Dementia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the PACE Program treatment for individuals with intellectual disabilities?

Research shows that structured physical activity programs can improve physical fitness, health, and quality of life for individuals with intellectual disabilities. These programs often include education and behavior change techniques, which help increase physical activity levels and improve various health outcomes. ^{1 2 3 4 5}

Is the Physical Activity Program for Intellectual Disability safe for participants?

Research shows that physical activity programs for people with intellectual disabilities generally have a low risk of causing harm. However, individuals with Down syndrome and atlantoaxial instability (a neck condition) may need extra caution. Overall, adverse events are not commonly reported. ^{1 3 5 6 7}

How is the PACE Program treatment different from other treatments for intellectual disability?

The PACE Program is unique because it focuses on promoting physical activity specifically for individuals with intellectual disabilities, aiming to improve their physical and psychosocial well-being through long-term engagement. Unlike other treatments, it integrates community-based activities and behavior change techniques to maintain adequate levels of physical activity and improve overall fitness and daily functioning. ^{1 3 5 7 8}

Research Team

Brianne R Tomaszewski, PhD., MPH

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• PACE Program (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

References

1. Mexico pubmed.ncbi.nlm.nih.gov

Interventions to promote physical activity for adults with intellectual disabilities. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Physical activity promotion and adults with intellectual disabilities: A neglected area. [2022]

3. Mexico pubmed.ncbi.nlm.nih.gov

Interventions to promote physical activity for youth with intellectual disabilities. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Effects of exercise on fitness in adults with intellectual disability: a protocol of an overview of systematic reviews. [2022]

5. England 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. [2019]

6. Canada pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: cognitive and psychological conditions. [2016]

7. England pubmed.ncbi.nlm.nih.gov

An initial evaluation of a long-term, sustainable, integrated community-based physical activity program for adults with intellectual disability. [2011]

8. United States pubmed.ncbi.nlm.nih.gov

A systematic review of interventions aiming to improve involvement in physical activity among adults with intellectual disability. [2018]