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Walk With Ease + Physical Therapy for Fall Prevention

Phase 1 & 2

Recruiting

Research Sponsored by Iowa State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 6 weeks, 6 months, 12 months

Awards & highlights

Study Summary

This trial evaluates if adding physical therapy exercises to an evidence-based program can reduce falls in older adults. It will also evaluate individualized therapy and habit-training resources to improve compliance.

Who is the study for?

This trial is for older adults, specifically those aged 65 or above who can stand for at least 10 minutes without pain and have their doctor's permission. It's not suitable for people who aren't at risk of falls or are already somewhat active with daily physical activity.Check my eligibility

What is being tested?

The study tests the 'Walk With Ease' program, which combines physical therapy exercises with behavioral training to prevent falls in older adults. Participants will be randomly assigned to receive either individually prescribed exercises or standardized ones.See study design

What are the potential side effects?

Since this trial involves exercise and behavioral training, side effects may include muscle soreness, fatigue, and possibly joint discomfort due to increased physical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 6 weeks, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 6 weeks, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 6 weeks, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Fall Risk

Change in Physical Activity Behavior

Secondary outcome measures

Change in Capability (to exercise)

Change in Enjoyment (of exercise)

Change in Falls Efficacy

+6 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced Training (ET)Experimental Treatment1 Intervention

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.

Group II: Enhanced Implementation (EI)Experimental Treatment1 Intervention

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.

Group III: Standard Implementation (SI)Active Control1 Intervention

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.

Group IV: Standard Training (ST)Active Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Group Exercise

2019

Completed Phase 3

~70

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Iowa State UniversityLead Sponsor

59 Previous Clinical Trials

144,313 Total Patients Enrolled

Candis M. Hunter, Ph.D.Study DirectorNational Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC)

Media Library

Behavioral Training Clinical Trial Eligibility Overview. Trial Name: NCT05693025 — Phase 1 & 2

Arthritis Research Study Groups: Enhanced Implementation (EI), Enhanced Training (ET), Standard Implementation (SI), Standard Training (ST)

Arthritis Clinical Trial 2023: Behavioral Training Highlights & Side Effects. Trial Name: NCT05693025 — Phase 1 & 2

Behavioral Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05693025 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for prospective participants in this clinical trial?

"Indeed, clinicaltrials.gov confirms that this experiment is actively recruiting participants. It was originally posted on February 27th 2023 and the most recent update was made on the same day. The study aims to enroll a total of 240 individuals at one site."

Answered by AI

What are the potential risks associated with utilizing Enhanced Implementation (EI) for individuals?

"Based on the Phase 2 trial evidence, it is assumed that Enhanced Implementation (EI) has achieved some level of safety so our team at Power gave this a rating of two. However, there is no information confirming its efficacy as of yet."

Answered by AI

What is the scale of recruitment for this medical experiment?

"Affirmative. According to clinicaltrials.gov, this medical study was initially posted on February 27th 2023 and is currently recruiting patients. It requires 240 individuals from a single location for participation."

Answered by AI

What is the objective of this experiment?

"This trial's primary outcome to be monitored during a 0, 6 week, and 12 month period is the Modification of Physical Activity Habits. Secondary goals include Variations in Bodily Capability (for exercising) assessed using two standard self-efficacy single item ratings for walking and stretching/strengthening exercise; Alteration of Opportunity (to practice physical activity) measured via habit strength for exercise utilizing four items from the Self-Report Behavioral Automaticity Scale; and Transformation of Physical Function evaluated with specific items taken from PROMIS' Health Assessment Questionnaire survey related to daily living activities connected to both physical behaviour and capability."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the Walk With Ease Program for Fall Prevention

Gregory Welk 2023. "Evaluation of the Walk With Ease Program for Fall Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05693025.

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