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NCT05982769 · ClinicalTrials.gov registry record · NA
Molecular Mechanism of Exercise in Cirrhosis
A NA study of Cirrhosis, Liver, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05982769 is a NA study of Cirrhosis, Liver that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 40 participants, below the 241-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05982769, a NA study of Cirrhosis, Liver, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to investigate the effects of 12 weeks of resistance or endurance exercise on patients with cirrhosis. Cirrhotic patients are prone to muscle loss (sarcopenia) and ammonia build up due to liver dysfunction. The liver which in healthy patients is able to process ammonia through ureagenesis is unable to do so in cirrhosis and ammonia is taken up either by the brain causing confusion or the skeletal muscle causing muscle loss or sarcopenia. Primary sarcopenia occurs in older individuals and can be mitigated by exercise. Secondary sarcopenia occurs in response to disease such as cancer, chronic kidney disease, multiple sclerosis, and cirrhosis of all etiologies. Resistance exercise is an excellent stimulator for muscle protein synthesis and is widely used to build muscle mass and strength but has little benefit to cardiovascular function. Endurance exercise has shown to be safe in cirrhosis however there is no set prescription for cirrhosis as there is for other disease. Endurance exercise is known to promote improved cardiovascular health, improve fatigue, and generates less ammonia build up than resistance exercise. In patients with low muscle mass it is possible that endurance exercise alone will be enough to improve muscle mass. There have been few studies on exercise and cirrhosis, those that exist have shown benefits with endurance exercise. However there are even more limited studies on resistance exercise and few to no studies on the molecular mechanisms behind exercise in cirrhosis. Study visits are described fully in the protocol and consent form. After passing a screening visit patients will undergo a maximal exercise/fitness test (pre-baseline test) and other body composition measurements. After the screening and pre-baseline visit randomization will occur (2:2:1 endurance, resistance, or SOC) arrangements will be made to have the appropriate exercise equipment given to patients. Once the exercise equipment has arrived a baseline study visit
Conditions Studied
Interventions
- BEHAVIORAL Standard of Care
- BEHAVIORAL Resistance Exercise
- BEHAVIORAL Endurance Training 3 times per week
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2027-08-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05982769
The ClinicalTrials.gov registry entry for NCT05982769 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 241-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (83% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cirrhosis, Liver appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care is the first listed.
NCT05982769 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT05982769 about?
NCT05982769 is a clinical study titled "Molecular Mechanism of Exercise in Cirrhosis". This study aims to investigate the effects of 12 weeks of resistance or endurance exercise on patients with cirrhosis. Cirrhotic patients are prone to muscle loss (sarcopenia) and ammonia build up due to liver dysfunction. The liver which in healthy patients is able to process ammonia through ureage...
What is the current status of trial NCT05982769?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2023-06-01. Estimated completion is 2027-08-10.
What conditions does trial NCT05982769 study?
This clinical trial studies the following conditions: Cirrhosis, Liver.
What interventions are being tested in trial NCT05982769?
The interventions under investigation include: Standard of Care (BEHAVIORAL), Resistance Exercise (BEHAVIORAL), Endurance Training 3 times per week (BEHAVIORAL).
Who is sponsoring clinical trial NCT05982769?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05982769 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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