Recruiting
Phase 1
Phase 2

Walk With Ease

Sponsor:

Iowa State University

Code:

NCT05693025

Conditions

Exercise

Frailty

Arthritis

Accidental Falls

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Group Exercise

Behavioral Training

Study Details

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

Study ID

NCT05693025

Start date

Feb 27, 2023

Status verified date

Mar, 2024

Completion date

May 15, 2026

Anticipated

Primary completion date

May 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

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

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 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).

Primary outcome measure

  • Change in Fall Risk [ Time Frame: 0, 6 weeks, 6 months, 12 months ]
  • Change in Physical Activity Behavior [ Time Frame: 0, 6 weeks, 6 months, 12 months ]

Central Contacts and Locations

Central contacts

Gregory J. Welk, Ph.D.

515-294-3583gwelk@iastate.edu

Locations

Department of Kinesiology

Recruiting

Ames, Iowa, United States, 50011

Contacts

Principal Investigator, Ph.D.

515-450-7585gwelk@iastate.edu

Clinical Research Coordinator, Ph.D.

5156814722jenil@iastate.edu

More Information

Sponsor

Iowa State University

Last update posted

Mar 7, 2024

Last verified

Mar, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Iowa State University on 2024-03-07.