Clinical trial NCT05693025: Evaluation of the Walk With Ease Program for Fall Prevention
Official title: Process and Outcome Evaluation of the Walk With Ease Program for Fall Prevention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Exercise
Frailty
Arthritis
Accidental Falls
Keywords: physical activity
fear of falling
balance
Walking
Older Adults
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study will use a 2x2 factorial randomized controlled trial to evaluate the combinations of two types of exercise prescription and two types of behavioral training. The exercise prescription factor evaluates the relative effectiveness of two implementation strategies for the group WWE format (Standard vs Enhanced). The behavioral training factor compares Standard content to Enhanced content focused on building habit formation. This feature will enable the simultaneous evaluation of strategies to promote compliance with exercise prescriptions, a main limitation of current physical therapy-based approaches to fall prevention.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility 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)

Primary outcomes:
measure: Change in Fall Risk
timeFrame: 0, 6 weeks, 6 months, 12 months
measure: Change in Physical Activity Behavior
timeFrame: 0, 6 weeks, 6 months, 12 months
Secondary outcomes:
measure: Change in Perceived Health
timeFrame: 0, 6 weeks, 6 months, 12 months.
measure: Change in Fear of Falling
timeFrame: 0, 6 weeks, 6 months, 12 months.
measure: Change in Physical Function
timeFrame: 0, 6 weeks, 6 months, 12 months.
measure: Change in Falls Efficacy
timeFrame: 0, 6 weeks, 6 months, 12 months
measure: Change in Capability (to exercise)
timeFrame: 0, 6 weeks, 6 months, 12 months.
measure: Change in Opportunity (to exercise)
timeFrame: 0, 6 weeks, 6 months, 12 months.
measure: Change in Motivation (to exercise)
timeFrame: 0, 6 weeks, 6 months, 12 months.
measure: Change in Enjoyment (of exercise)
timeFrame: 0, 6 weeks, 6 months, 12 months
measure: Change in Overall Strength
timeFrame: 0, 6 Weeks
Other outcomes:
Locations:
city: Ames
country: United States
facility: Department of Kinesiology
state: Iowa
Study officials:
affiliation: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC)
name: Candis M. Hunter, Ph.D.
role: STUDY_DIRECTOR
References: