Evaluation of the Walk With Ease Program for Fall Prevention

NCT05693025 | Recruiting Phase 1 DMC

• 1 other identifier: U01CE003490
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise; Frailty; Arthritis; Accidental Falls

Keywords

physical activity; fear of falling; balance; Walking; Older Adults

Outcome Measures

Primary Outcomes (2)

• Change in Fall Risk

  Reported falls will be tracked using surveys as well as from the electronic medical record data. Reductions in fall risk will be evaluated using indicators from the established STEADI protocol with continuous fall risk scores computed using a validated algorithm.

  0, 6 weeks, 6 months, 12 months

• Change in Physical Activity Behavior

  PA behavior will be captured using the International Physical Activity Questionnaire - Elderly (IPAQ-E) will be evaluated at all time points to estimate minutes of physical activity. While less robust than monitor-based methods, the IPAQ-E has been validated against criterion measures of physical activity and has demonstrated adequate sensitivity and specificity for evaluating physical activity among adults aged 65 years and older.

  0, 6 weeks, 6 months, 12 months

Secondary Outcomes (9)

• Change in Perceived Health

  0, 6 weeks, 6 months, 12 months.

• Change in Fear of Falling

  0, 6 weeks, 6 months, 12 months.

• Change in Physical Function

  0, 6 weeks, 6 months, 12 months.

• Change in Falls Efficacy

  0, 6 weeks, 6 months, 12 months

• Change in Capability (to exercise)

  0, 6 weeks, 6 months, 12 months.

Study Arms (4)

Standard Implementation (SI)

ACTIVE COMPARATOR

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.

Behavioral: Group Exercise

Enhanced Implementation (EI)

EXPERIMENTAL

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.

Behavioral: Group Exercise

Standard Training (ST)

ACTIVE COMPARATOR

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.

Behavioral: Behavioral Training

Enhanced Training (ET)

EXPERIMENTAL

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.

Behavioral: Behavioral Training

Interventions

Group Exercise BEHAVIORAL

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).

Enhanced Implementation (EI); Standard Implementation (SI)

Behavioral Training BEHAVIORAL

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).

Enhanced Training (ET); Standard Training (ST)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• being able to stand for at least 10 minutes without pain
• written permission from a physician

You may not qualify if:

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

Sponsors & Collaborators

• Iowa State University: lead

Study Sites (1)

Department of Kinesiology

Ames, Iowa, 50011, United States

RECRUITING

Related Publications (1)

• Lamoureux NR, Lansing J, Dixon PM, Phillips LA, Radske-Suchan T, Dorneich MC, Chou LS, Welk GJ. Study protocol: process and outcome evaluation of the Walk with Ease program for fall prevention. BMC Public Health. 2024 Sep 28;24(1):2658. doi: 10.1186/s12889-024-20138-z.

  PMID: 39342204 DERIVED

MeSH Terms

Conditions

Motor Activity; Frailty; Arthritis

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Candis M. Hunter, Ph.D.

  National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC)

  STUDY DIRECTOR

Central Study Contacts

Gregory J. Welk, Ph.D.

CONTACT

515-294-3583; gwelk@iastate.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 20, 2023
• Study Start: February 27, 2023
• Primary Completion: May 15, 2025
• Study Completion (Estimated): May 15, 2026
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year after the study is completed (12/31/26)
• Access Criteria: Data sharing agreement

Locations

US (1)