CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Nutritional consultation +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02776553
NCT02776553N/ACompleted

A Physical Activity Program in End-stage Liver Disease: Pilot Study Assessing Changes in Physical Fitness, Sarcopenia, and the Metabolic Profile

University of Arkansas·interventional·Posted May 18, 2016·Updated Aug 6, 2020

In Brief

A clinical study evaluating Nutritional consultation, Physical training program, and 1 other intervention for End-stage Liver Disease (ESLD) and 5 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The primary aim of this study is to improve both physical fitness and sarcopenia of patients with ESLD who are potentially eligible for liver transplantation through a 12-week physical training program. Secondary aims will focus on changes in anthropometrics, body composition, quality of life, and metabolic profile. This is a randomized clinical trial including 50 patients, with half allocated to the active group (physical training program) and half to standard of care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 18, 2016
Enrollment StartJun 1, 2016
Primary CompletionMay 1, 2020
Study CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.1 years ago

Interventions

Nutritional consultationother

Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids

Physical training programbehavioral

Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.

Behavioral modification therapybehavioral

The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits.