Trials / Completed
CompletedNCT02776553
A Physical Activity Program in End-state Liver Disease
A Physical Activity Program in End-stage Liver Disease: Pilot Study Assessing Changes in Physical Fitness, Sarcopenia, and the Metabolic Profile
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Arkansas · Academic / Other
- Sex
- All
- Age
- 40 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- End-stage Liver Disease (ESLD)
- Liver Transplant
- Sarcopenia
- Poor Physical Fitness
- Cirrhosis
- Portal Hypertension
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Nutritional consultation | 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 |
| BEHAVIORAL | Physical training program | 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 | Behavioral modification therapy | 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. |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2020-05-01
- Completion
- 2020-06-01
- First posted
- 2016-05-18
- Last updated
- 2020-08-06
- Results posted
- 2020-08-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02776553. Inclusion in this directory is not an endorsement.