Neuromuscular electrical stimulation for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Vermont Medical Center, Burlington, VT
Heart Failure+1 More
Neuromuscular electrical stimulation - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The goal of this research study is to understand whether an at-home exercise program started after hospitalization for HFpEF, and continuing for 4 weeks following discharge from the hospital, can preserve or improve physical function.

Eligible Conditions

  • Heart Failure
  • Heart Failure With Preserved Ejection Fraction (HFpEF)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Hospital discharge (Within 1 day) and 4-weeks post-discharge

Day 1
6 Minute Walk Distance (6MW)
Short Physical Performance Battery
Day 1
Katz Index of Independence in Activities of Daily Living
Lawton Instrumental Activities of Daily Living (IADL) Scale
Medical Outcome Short Form 36 - Role Physical
Medical Outcomes Short Form 36
Medical Outcomes Short Form 36 - Bodily Pain
Medical Outcomes Short Form 36 - General Health
Medical Outcomes Short Form 36 - Physical Function
Medical Outcomes Short Form 36 - Role Emotional
Medical Outcomes Short Form 36 - Social Function
Medical Outcomes Short Form 36 - Vitality

Trial Safety

Safety Progress

1 of 3

Side Effects for

Microstimulation
9%Re-injury of ACL (graft failure)
9%Re-injury of meniscus
0%Procedural complication.
0%Muscle strain
This histogram enumerates side effects from a completed 2019 Phase 1 & 2 trial (NCT02945553) in the Microstimulation ARM group. Side effects include: Re-injury of ACL (graft failure) with 9%, Re-injury of meniscus with 9%, Procedural complication. with 0%, Muscle strain with 0%.

Trial Design

2 Treatment Groups

Control
1 of 2
Neuromuscular electrical stimulation
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Neuromuscular electrical stimulation · No Placebo Group · N/A

Neuromuscular electrical stimulation
Device
Experimental Group · 1 Intervention: Neuromuscular electrical stimulation · Intervention Types: Device
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neuromuscular electrical stimulation
2018
Completed Phase 2
~510

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: hospital discharge (within 1 day) and 4-weeks post-discharge
Closest Location: University of Vermont Medical Center · Burlington, VT
Photo of vermont 1Photo of vermont 2Photo of vermont 3
2021First Recorded Clinical Trial
7 TrialsResearching Heart Failure
87 CompletedClinical Trials

Who is running the clinical trial?

University of Vermont Medical CenterLead Sponsor
33 Previous Clinical Trials
25,289 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.