We Walk Plus Program for Older Adults with Intellectual Disabilities

Not currently recruiting at 1 trial location

Overseen By Andrew DeMott, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Coronary disease, Uncontrolled hypertension, Mental illness, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the We Walk Plus program can help older adults with intellectual disabilities become more active and improve their thinking skills. Participants will receive a Fitbit to track their steps and weekly motivational messages to encourage more walking. The trial seeks adults with mild to moderate intellectual disabilities who are physically inactive, able to walk, and willing to use a Fitbit and receive text messages. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the We Walk Plus intervention is safe for older adults with intellectual disabilities?

Research shows no specific safety data for the We Walk Plus Program yet. However, similar walking programs have been well-tolerated and often help people become more active without causing serious side effects.

Participants in the We Walk Plus Program receive close monitoring. Regular safety checks ensure any potential issues are quickly addressed. The program includes using a Fitbit and receiving motivational text messages to encourage walking, both of which are generally safe for most people.

Since this trial is in the "Not Applicable" phase, it focuses more on testing the program's practicality and acceptability rather than its safety. However, using familiar tools like a Fitbit suggests it is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the We Walk Plus Intervention because it offers a novel approach to increasing physical activity among older adults with intellectual disabilities. Unlike standard recommendations that simply encourage more walking, this program combines technology and social motivation by providing participants with Fitbits, personalized SMS messages, and a supportive online community. The unique integration of real-time monitoring and personalized communication helps keep participants engaged and motivated, making it more likely for them to achieve their physical activity goals. This approach not only aims to boost physical health but also fosters a sense of community and accomplishment, which could significantly enhance the overall well-being of participants.

What evidence suggests that the We Walk Plus intervention is effective for promoting physical activity and improving cognition in older adults with intellectual disabilities?

Research has shown that the We Walk Plus program, which participants in this trial may receive, can help older adults with intellectual disabilities become more active. Programs like this have proven effective in improving health habits and reducing health disparities in disadvantaged groups. The We Walk Plus program uses a Fitbit to track participants' movement and includes social networking for support. By setting personal and team step goals, participants are encouraged to walk more. This method has proven practical and well-received for boosting physical activity and enhancing cognitive skills. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for men and women aged 35-60 with mild or moderate intellectual disabilities. Participants must speak English, consent to enroll, be willing to receive SMS, wear a Fitbit during the study, live with family or in community housing, and have support persons to help with the device. They should be physically inactive but able to walk and follow instructions.

Inclusion Criteria

You live with family or in a community residence.

I have a mild or moderate intellectual disability.

Able to speak, read English and willing to provide consent to enroll

Exclusion Criteria

I have heart disease, high blood pressure, smoke, or am physically active.

Support persons unable or unwilling to assist participants with Fitbit devices, if needed

You have a mental illness or behavior issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a Fitbit, personalized SMS, and join a private Fitbit community for 12 weeks to promote physical activity

12 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• We Walk Plus Intervention

Trial Overview The We Walk Plus Study tests an intervention designed to encourage physical activity and enhance cognitive function in older adults with intellectual disabilities. It involves using a Fitbit and receiving SMS messages as part of the program.

How Is the Trial Designed?

Group I: We Walk Plus Intervention Experimental Treatment 1 Intervention

The intervention group will receive a Fitbit, SMS and will be assigned to a private Fitbit community (4-5 participants per group) for 12 weeks. During the intervention, participants will receive weekly personalized SMS on their mobile phones including encouraging messages, reminders, and tips to increase steps, and weekly step goals. The investigators will use a secure, web-based platform, iCardia, to support continuous real-time remote monitoring of activity data from Fitbit devices and personalized communication via SMS based on incoming data. The investigators will set up the Fitbit networking settings on participants' phones to give notifications when there are posts to this group. Individual goals and a weekly team goal of steps will be set up by the research team. Each member will be awarded a badge upon reaching each individual's weekly goal. Teams will also be awarded badges when all team members reach their individual weekly goals.

Group II: Attention control group Active Control 1 Intervention

The attention control group will also receive a Fitbit and will be asked to continue with normal daily activities. During the initial in-person session, they will receive the same PA recommendations as the intervention group to walk at least 30 minutes for 5 days or more a week or 10,000 steps a day. However, a plan for improving PA will not be discussed.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

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]

A study of 1050 individuals over 50 with intellectual disabilities revealed that their health declines significantly earlier than the general population, with increased cardiovascular risks, depression, and sleep disorders often going undiagnosed.

To improve health outcomes and maintain independence in this group, there is a need for better training for caregivers, development of multidisciplinary guidelines, and enhanced access to specialized outpatient clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Poor health at an earlier age: frailty in people with intellectual disabilities]. Evenhuis, HM.[2018]

The Walk Well intervention is a randomized controlled trial designed to assess the effectiveness of a walking program specifically for adults with intellectual disabilities, aiming to improve their physical activity levels and overall wellbeing.

Participants will be monitored for changes in daily steps, physical activity intensity, sedentary behavior, quality of life, self-efficacy, and weight over a 12-week period, providing comprehensive data on the intervention's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walk Well: a randomised controlled trial of a walking intervention for adults with intellectual disabilities: study protocol. Mitchell, F., Melville, C., Stalker, K., et al.[2023]

The 'Walk Well' walking intervention, involving 102 adults with intellectual disabilities over 12 weeks, did not significantly increase daily step counts, indicating that this specific approach may not be effective for enhancing physical activity in this population.

The process evaluation revealed that while the intervention was feasible and well-received, future studies should consider longer intervention durations, more frequent contact, and strategies to better engage carers to support participants in their activity goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process evaluation of the Walk Well study: a cluster-randomised controlled trial of a community based walking programme for adults with intellectual disabilities. Matthews, L., Mitchell, F., Stalker, K., et al.[2022]

Older adults with Intellectual Disability are heavily medicated, often experiencing polypharmacy that increases their risk of medication-related harm, particularly from high-risk medications like anticholinergics and sedatives.

There is a significant lack of evidence regarding the safety of medications in this population, and they are frequently excluded from clinical trials, highlighting the need for better research and tools to assess medication risks and improve healthcare quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring drug burden in older adults with intellectual disabilities: Critical issues for consideration in finding the optimal measure to improve safety of medicines use. O'Dwyer, M., McCallion, P., McCarron, M., et al.[2021]

In a 12-week pilot project involving 12 older adults with intellectual disabilities, 92% of participants showed improvement in at least one area of physical function, indicating the efficacy of the physical activity intervention.

The program was well-received, with high participation rates, and many participants maintained their functional improvements even one year after the program ended, suggesting sustainability of the intervention by day habilitation staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity intervention for older adults with intellectual disability: report on a pilot project. Podgorski, CA., Kessler, K., Cacia, B., et al.[2011]

A 10-week multicomponent intervention program for 43 community-dwelling individuals with intellectual disabilities showed significant improvements in cardiovascular health, specifically increasing high-density lipoprotein (HDL) cholesterol levels in the experimental group compared to the control group.

The intervention, which included exercise, nutrition management, and behavior modification, was safe with no adverse events reported, indicating its potential as a beneficial health strategy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Multicomponent Intervention Program on Community-Dwelling People With Intellectual Disabilities. Kim, YS., Moon, JH., Hong, BK., et al.[2020]

In a study involving 1,050 older adults with intellectual disabilities, eight physical fitness tests were found to be feasible for measuring fitness in most participants, indicating their potential utility in health assessments.

However, the tests were less feasible for individuals with profound or severe intellectual disabilities and for wheelchair users, suggesting the need for alternative assessment methods for these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of eight physical fitness tests in 1,050 older adults with intellectual disability: results of the healthy ageing with intellectual disabilities study. Hilgenkamp, TI., van Wijck, R., Evenhuis, HM.[2013]

The analysis identified key attributes of transitioning to long-term care for older adults with intellectual disabilities, emphasizing the need for planned relocations that are person-centered and involve supported decision-making.

There is a significant lack of empirical evidence regarding the experiences of older adults with intellectual disabilities during these transitions, highlighting the necessity for future research to better incorporate their perspectives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitioning to long-term care for older adults with intellectual disabilities: A concept analysis. Egan, C., Mulcahy, H., Naughton, C.[2022]

A systematic review of 36 studies highlights the need for effective psychosocial interventions tailored for elderly individuals with intellectual disabilities, addressing their unique support needs as life expectancy increases.

The review emphasizes the varying roles of support staff in implementing these interventions, which can be crucial for optimizing care and improving the quality of life for this growing population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial interventions for older people with intellectual disabilities and the role of support staff: A systematic review. Thalen, M., Volkers, KM., van Oorsouw, WMWJ., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04573530?cond=%22Intellectual%20Disability%22&aggFilters=status:not%20rec&rank=10

We Walk Plus Study for Older Adults With Intellectual ... We Walk Plus study consists of: (1) a user friendly physical activity tracker (i.e., Fitbit Charge HR ); (2) user-centered social networking (e.g., Fitbit ...

2. trialx.com trialx.com/clinical-trials/listings/220407/we-walk-plus-study-for-older-adults-with-intellectual-disabilities/?&radius=50

We Walk Plus Study for Older Adults With Intellectual ... Determine the feasibility and acceptability of We Walk Plus intervention to promote physical activity and improve cognition for older adults ...

3. 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.

4. midwestroybalcenter.uic.edu midwestroybalcenter.uic.edu/research/we-walk-plus-study-a-walking-program-using-physical-activity-monitors-and-social-media-for-older-adults-with-intellectual-disabilities/

We Walk Plus Study: A Walking Program using Physical ... This study is intended to determine the feasibility and acceptability of We Walk Plus intervention to promote physical activity and improve cognition for older ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12489171/

Natural Setting Interventions to Increase Physical Activity ... The present study aimed to understand the effectiveness of natural setting interventions to increase the level of PA in older adults (≥ 40 years ...

6. withpower.com withpower.com/trial/phase-intellectual-disability-5-2021-c0f6f

We Walk Plus Program for Older Adults with Intellectual Disabilities The available research does not provide specific safety data for the We Walk Plus Program, but similar walking interventions have been shown to improve ...