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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active (physical training program) | Experimental | physical activity + behavioral therapy + nutritional intervention |
|
| Control | Active Comparator | nutritional intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional consultation | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Fitness - VO2 | Peak VO2 will be obtained from cardiorespiratory stress test | Change from Baseline to 12 weeks after baseline |
| Physical Fitness - Distance Walked | Total distance walked during 6-minute walk test | Change from Baseline to 12 weeks after baseline |
| Sarcopenia | Total thigh muscle volume (cm^3), as determined by CT-scan. | Change from Baseline to 12 weeks after baseline |
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Inclusion Criteria:
Age 40 to 70.
Cirrhosis, any cause, defined as:
Creatinine <2.0 mg/dL.
Physiologic Model for End Stage Liver Disease (MELD) ≥10.
Decompensated cirrhosis with active or history of variceal bleeding, ascites, hepatic encephalopathy, or jaundice.
Potential transplant candidate as per UAMS criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andres Duarte-Rojo, MD | University of Arkansas Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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227 Subjects were recruited from the UAMS liver transplant clinic. 207 were excluded for meeting exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active (Physical Training Program) | physical activity + behavioral therapy + nutritional intervention 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 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 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. |
| FG001 | Control | nutritional intervention 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active (Physical Training Program) | physical activity + behavioral therapy + nutritional intervention 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 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physical Fitness - VO2 | Peak VO2 will be obtained from cardiorespiratory stress test | Posted | Mean | Standard Deviation | mL oxygen/kg/min | Change from Baseline to 12 weeks after baseline |
|
Approximately 4 months duration per subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active (Physical Training Program) | physical activity + behavioral therapy + nutritional intervention 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 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 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arny A. Ferrando, Ph.D. | University of Arkansas for Medical Sciences | 501-526-5711 | aferrando@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2018 | Jun 23, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| D055948 | Sarcopenia |
| D005355 | Fibrosis |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Physical training program | Behavioral | 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 therapy | Behavioral | 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. |
|
| had other surgery |
|
| Protocol Violation |
|
| BG001 | Control | nutritional intervention 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Etiology of cirrhosis-NASH/cryptogenic | Count of Participants | Participants |
|
| Etiology of cirrhosis-Hepatitis C | Count of Participants | Participants |
|
| Etiology of cirrhosis-Alcoholic | Count of Participants | Participants |
|
| Etiology of cirrhosis-Cholestatic | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Use of beta-blocker | Count of Participants | Participants |
|
| Esophageal varices | Count of Participants | Participants |
|
| Prior variceal bleeding | Count of Participants | Participants |
|
| Ascites | Count of Participants | Participants |
|
| Large volume paracentesis | Count of Participants | Participants |
|
| Hepatic encephalopathy | Count of Participants | Participants |
|
| Child-Turcotte-Pugh Score [median (range)] | This clinical score is an indicator of severity of liver disease. It is derived from 5 clinical domains: hepatic encephalopathy, ascites, INR (international normalized ratio) or prothrombin time, serum albumin, and total bilirubin. In each domain, a score is given from 1 (best health) to 3 (worst health); therefor the total possible range is 5-15 with higher scores indicative of worse liver disease. | Median | Full Range | units on a scale |
|
| Child-Turcotte-Pugh Class B | This clinical classification is an indicator of severity of liver disease. It is derived from the total Child-Turcotte-Pugh score (range is 5-15) with higher scores indicative of worse liver disease. A total score of 7-9 is designated Class B - moderate liver disease (worse than Class A, but better than Class C). | Count of Participants | Participants |
|
| Child-Turcotte-Pugh Class C | This clinical classification is an indicator of severity of liver disease. It is derived from the total Child-Turcotte-Pugh score (range is 5-15) with higher scores indicative of worse liver disease. A total score of 10-15 is designated Class C - severe liver disease (worse than Class A and Class B). | Count of Participants | Participants |
|
| D'Amico Stage 4 | A set of clinical criteria that is used to stratify liver disease into five stages. The criteria include presence or absence of ascites, varices, and bleeding. Higher stages indicate more severe liver disease and increased risk of death. | Count of Participants | Participants |
|
| D'Amico Stage 5 | A set of clinical criteria that is used to stratify liver disease into five stages. The criteria include presence or absence of ascites, varices, and bleeding. Higher stages indicate more severe liver disease and increased risk of death. | Count of Participants | Participants |
|
| Total bilirubin (mg/dL) | Mean | Standard Deviation | mg/dL |
|
| ALT | Mean | Standard Deviation | units per liter |
|
| AST | Mean | Standard Deviation | units per liter |
|
| Albumin | Mean | Standard Deviation | g/dL |
|
| Hemoglobin | Mean | Standard Deviation | g/dL |
|
| Platelets | Mean | Standard Deviation | thousand platelets/microliter |
|
| INR | The international normalised ratio (INR) is a laboratory measurement of how long it takes blood to form a clot. If an INR score is too low, a patient can be at risk for a blood clot. However, if the INR is too high, patients could also experience bleeding. A typical INR score ranges between 2 to 3. The "ideal" INR score can vary from patient to patient. | Mean | Standard Deviation | units on a scale |
|
| Creatinine | Mean | Standard Deviation | mg/dL |
|
| Sodium | Mean | Standard Deviation | mEq/L |
|
| MELD-sodium | This is primarily used to stratify patients ≥12 years old on liver transplant waiting lists. It also predicts mortality in the following scenarios: (a) after transjugular intrahepatic portosystemic shunt (TIPS), (b) cirrhotic patients undergoing non-transplantation surgical procedures, (c) acute alcoholic hepatitis, and (d) acute variceal hemorrhage. It is derived from: the frequency of dialysis, creatinine, bilirubin, sodium, and INR (international normalised ratio-an indicator of blood-clotting efficiency). The full range is 6-40, with higher numbers indicating more severe disease. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Control | nutritional intervention 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 |
|
|
|
| Primary | Physical Fitness - Distance Walked | Total distance walked during 6-minute walk test | Posted | Mean | Full Range | meters | Change from Baseline to 12 weeks after baseline |
|
|
|
|
| Primary | Sarcopenia | Total thigh muscle volume (cm^3), as determined by CT-scan. | Posted | Mean | 95% Confidence Interval | cubic centimeters | Change from Baseline to 12 weeks after baseline |
|
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Control | nutritional intervention 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 | 0 | 8 | 0 | 8 | 0 | 8 |
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| D009133 |
| Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010335 | Pathologic Processes |