Home exercise program for Frailty
Phase-Based Progress Estimates
Effectiveness
Safety
University of Michigan, Ann Arbor, MI
Frailty+1 More
Home exercise program - BehavioralEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
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Study Summary
The purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in individuals with Fontan heart physiology, demonstrate that a telemedicine exercise program reduces socioeconomic and geographic barriers to access to exercise training, and to explore the impact of a structured exercise program on markers of Fontan-associated liver disease.
Eligible Conditions
- Fontan Physiology
- Frailty
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 12 Secondary · Reporting Duration: Baseline, 6 months
Baseline, 6 months
Change in 7-day average step count over 6 month period
Week 26
Change in 6-minute walk distance
Change in Alanine Aminotransferase (ALT)
Change in Aspartate Transferase (AST)
Change in Enhanced Liver Fibrosis (Elf) Score number
Change in Frailty score by the Fried frailty instrument
Change in Gamma-glutamyl Transferase (GGT)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - 29
Change in alpha fetoprotein (AFP)
Change in liver stiffness measured by ultrasound
Change in oxygen consumption at anaerobic threshold
Change in peak oxygen consumption
Change in platelets
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Home exercise program
1 of 1
Experimental Treatment
53 Total Participants · 1 Treatment Group
Primary Treatment: Home exercise program · No Placebo Group · N/A
Home exercise program
Behavioral
Experimental Group · 1 Intervention: Home exercise program · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home exercise program
2017
Completed Phase 3
~500
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 months
Trial Background
Prof. Jesse Hansen, Assistant Professor of Pediatrics
Principal Investigator
University of Michigan
Closest Location: University of Michigan · Ann Arbor, MI
2022First Recorded Clinical Trial
3 TrialsResearching Frailty
1003 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are 18 years old or older.
About The Reviewer
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.
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