Home exercise program for Frailty

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan, Ann Arbor, MI
Frailty+1 More
Home exercise program - Behavioral
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

1 of 3

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

1 of 3

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: Behavioral
Treatment
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
Photo of university of michigan comprehensive cancer center  1Photo of university of michigan comprehensive cancer center  2Photo of university of michigan comprehensive cancer center  3
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 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.