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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Fall Risk
Change in Physical Activity Behavior
Secondary study objectives
Change in Capability (to exercise)
Change in Enjoyment (of exercise)
Change in Falls Efficacy
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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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
61 Previous Clinical Trials
144,574 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
Frailty Research Study Groups: Enhanced Implementation (EI), Enhanced Training (ET), Standard Implementation (SI), Standard Training (ST)
Frailty 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
~55 spots leftby May 2025
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