Evaluation of the Walk With Ease Program for Fall Prevention

Study Purpose

The study will use a randomized controlled trial design to evaluate the potential of incorporating physical therapy exercises (primary prevention strategy) within an evidence-based intervention called Walk with Ease to reduce falls and fall risk in older, community-dwelling older adults. The integrated process and outcome evaluation will determine the relative effectiveness of individually prescribed exercises (compared to standardized exercises) as well as the potential of 'habit training' resources to improve compliance with exercises in this population. The study, conducted through a local clinical / community partnership will advance both science and practice while also informing implementation strategies needed to promote broader dissemination.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	65 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Inclusion criteria include age of 65 years or older.

- being able to stand for at least 10 minutes without pain.

- written permission from a physician.

Exclusion Criteria:

- Already somewhat active (defined as at least 15 minutes of physical activity per day) - Not at risk for falls (based on STEADI criteria)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05693025
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Iowa State University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Candis M. Hunter, Ph.D.
Principal Investigator Affiliation	National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Exercise, Frailty, Arthritis, Accidental Falls

Additional Details

The study will evaluate the effectiveness of incorporating physical therapy exercises (primary prevention strategy) within an established physical activity intervention called Walk with Ease (WWE) to reduce incidence and risk of falls in community-dwelling older adults. A randomized controlled design will be used to systematically test the Standard Implementation (SI) model with generic exercise recommendations against an Enhanced Implementation (EI) model that provides individually-prescribed, physical therapy exercises. Standard Education (SE) resources will also be directly compared against an Enhanced Education (EE) resources based on theory-based, habit formation approaches using a 2 x 2 factorial approach. The primary hypothesis is that the participants in the EI condition will have lower incidence of falls and larger reductions in fall risk than those in the SI condition. The secondary hypothesis is that participants receiving the EE resources will have greater compliance to the prescribed exercise, higher levels of physical activity, and better fall risk reduction outcomes than those receiving SE resources. The study will include a robust process evaluation (Aim 1) and outcome evaluation (Aim 2), along with a supplemental feasibility study (Aim 3) to identify actionable factors within the implementation context that could positively influence the scalability of WWE to reach rural populations. The primary outcome based on the frequency of falls will be analyzed with a negative binomial regression model. The primary interest is in the β coefficient that quantifies the program main effect, averaged over behavioral treatments. If dropout is informative, we will impute the missing observations using a mixed model to account for variability between individuals. The primary hypothesis will also be evaluated using a continuous fall risk score developed by Helsel et al. based on longitudinal fall risk data. Assuming normally distributed data, our primary hypothesis will be a contrast evaluating the average change between baseline and 6 weeks in the two enhanced program treatments. We will recruit 240 participants into the overall trial and project a final sample of 180 completers, based on a 25% dropout rate, providing a final sample size is 45 individuals in each of the four treatment groups. Based on outcomes from a related clinical trial by Li et al.70 we would have 80% power to detect a 14% reduction in fall frequency between conditions and 95% power to detect a 18% reduction in fall frequency between conditions. Using the continuous risk score proposed by Helsel et al. we would have 80% power to detect a 0.7 unit change in Helsel score or an 11% increase in the odds of a fall in one year. We would have 95% power to detect a 0.8 unit change in Helsel score or an 13% increase in the odds of a fall in one year.

Arms & Interventions

Arms

Active Comparator: Standard Implementation (SI)

Participants the Standard Implementation (SI) model complete a 6 week structured Walk with Ease group exercise program designed to build capacity and function in older adults. Sessions are held 3 days a week for an hour each session. Each session includes a 10 minute warmup including strength/flexibility exercises, a 30 minute bout of walking and a 10 minute cool-down including strength/flexibility exercises. Participants complete standard exercises recommended in the base program.

Experimental: Enhanced Implementation (EI)

Participants the Enhanced Implementation (SI) model complete the 6 week structured Walk with Ease group exercise program designed to build capacity and function in older adults. Sessions are held 3 days a week for an hour each session. Each session includes a 10 minute warmup including strength/flexibility exercises, a 30 minute bout of walking and a 10 minute cool-down including strength/flexibility exercises. Participants complete personalized exercises prescribed by a licensed Physical Therapist to help reduce potential risks of falling.

Active Comparator: Standard Training (ST)

Participants the Standard Training (ST) model receive access to on online portal with weekly tips and education content, goal setting options and a daily tracking system for logging walking and exercises performed. They receive instruction on how to use the portal and are encouraged to use the integrated eBook and resources to supplement the group exercise programming. Weekly video-based lessons provide standard knowledge-based training about how to become more physically active.

Experimental: Enhanced Training (ET)

Participants the Enhanced Training (ET) model receive access to on online portal with weekly tips and education content, goal setting options and a daily tracking system for logging walking and exercises performed. They receive instruction on how to use the portal and are encouraged to use the integrated eBook and resources to supplement the group exercise programming. Weekly video-based lessons provide habit-formation training about how to form regular habits for physical activity. Participants are paired with a student 'coach' trained in motivational interviewing skills to provide virtual assistance in maintaining motivation during the programming.

Interventions

Behavioral: - Group Exercise

The study evaluates two different approaches for group exercise. Participants in the Standard Implementation (SI) group complete the standard Walk with Ease intervention as recommended by the Arthritis Foundation. Participants are guided to learn and perform a series of stretching and strengthening exercises recommended in the base WWE program. Primary BCTs include instruction on how to perform behavior (#4.1) and Graded tasks (#8.7). Participants in the Enhanced Implementation (SI) group complete the standard Walk with Ease intervention as recommended by the Arthritis Foundation. They may perform some of the same exercises as those in the SI group but they are also guided to learn and perform specific exercises prescribed by a physical therapist to improve balance and reduce risks of falling. The primary BCTs include instruction on how to perform behavior (#4.1), Graded tasks (#8.7) from the base program as well as Information on health consequences (#5.1) and Credible source (#9.1).

Behavioral: - Behavioral Training

The study evaluates two different approaches for promoting behavior change. Participants in the Standard Training (ST) model follow the standardized Walk with Ease training to support behavior change. Participants are provided with goal setting tools and an online tracker to monitor their progress. Weekly video-based lessons, resource links and eBook content support behavior change. Primary BCTs include Goal Setting (BCT #1.1) and self-monitoring (BCT#2.3). Participants in the Enhanced Training (ET) model access the same basic content as the ST model, but the weekly education-based videos are replaced with lessons focus on habit-formation training. Student coaches are also assigned to individual participants to support behavior change efforts using motivational interviewing strategies. Thus, participants in the ET model also receive two additional theory- and evidence-based BCTs: (1) habit formation training (BCT#1.2, #1.4, #8.3) and (2 health coaching (BCT# 3.3).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Department of Kinesiology, Ames, Iowa

Status

Recruiting

Address

Department of Kinesiology

Ames, Iowa, 50011

Site Contact

Principal Investigator, Ph.D.

[email protected]

515-450-7585

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