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Frailty and muscle health are important for patients with chronic liver disease. This study looks at the use of a digital prehabilitation app (HEAL-ME) plus creatine and whey protein combination supplementation on maintaining muscle health in patients with liver disease. The investigators anticipate that this combination of supplementation and nutrition/exercise prehabilitation app will maintain muscle health in patients with liver disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEAL-ME and placebo supplementation | Placebo Comparator | Patients within this arm will be administered the HEAL-ME digital app and placebo supplementation daily |
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| HEAL-ME and creatine/whey protein supplementation | Experimental | Patients within this arm will be administered the HEAL-ME digital app and whey protein/creatine combination supplementation daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEAL-ME digital app | Behavioral | HEAL-ME is a digital prehabilitation app that provides semi-guided nutrition/exercise prehabilitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frailty | Frailty will be used to assess muscle quality. The liver frailty index (LFI) includes the measurement of grip strength, chair stands, and balance. The Liver Fraity Index typically ranges from 1.0 to 5.0 with the following cut-offs: Robust is Liver Frailty Index <3.2, Pre-frail is Liver Frailty Index between 3.2 and 4.4, and Frail is Liver frailty Index ≥4.4. We will use the previously identified cut-off of ≥4.4 (frail) vs. <4.4 (not frail) to identify frailty in this study. | From enrollment to end of study at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Completion Rate | Completion rate will be assessed by study coordinators. Study coordinators will identify patients who do or do not complete the study during check-ins. Reasons for dropping out of the study will be recorded by study coordinators. | From study enrollment to end of study at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melinda Wang, MD, MHS | Contact | 415-476-2777 | melinda.wang3@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Lai, MD, MBA | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D000073496 | Frailty |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D009752 | Nutritional Status |
| D003401 | Creatine |
| D000067796 | Whey |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Creatine supplementation | Dietary Supplement | Patients will take 5g creatine supplementation daily for 13 weeks |
|
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| Whey protein supplementation | Dietary Supplement | Patients will take 35g whey protein supplementation daily |
|
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| Placebo | Dietary Supplement | Patients will be administered daily placebo supplementation. |
|
| Health-related quality of life (HRQOL) |
The Patient Reported Outcomes Measurement Information System (PROMIS)-29 v 2.0 is a NIH-supported effort to develop and disseminate patient-reported measures of HRQOL that has built-in normative reference to the US general population. The PROMIS-29 v2.0 will be used to assess HRQOL. A score ≤25 has been used to define the 25th percentile value for the general population and has previously been used in our studies to be considered poor HRQOL. |
| From enrollment to end of study at 12 weeks |
| Self-Reported Physical Activity | The Duke Activity Status Index (DASI) will be used to measure self-reported physical activity. The DASI questionnaire provides a score from 0 to 58.2 with higher scores indicating better functional status and lower score indicating worse functional status. DASI will be measured as a continuous variable | From enrollment to end of study at 12 weeks |
| Sarcopenia | Sarcopenia will be measured by abdominal computed tomography (CT) scan measured CT-quantified skeletal muscle index (skeletal muscle index (SMI) <50 cm2/m2 for men and <39 cm2/m2 for women). We have previously demonstrated that CT-quantified sarcopenia is associated with worse outcomes in patients with cirrhosis. | From enrollment to end of study at 12 weeks |
| Feasibility: Adherence Rate | Adherence rate will be assessed by study coordinators at each check-in. Adherence rate will include total adherence to the study protocol, adherence to supplement/placebo, and adherence to HEAL-ME activities. | From study enrollment to end of study at 12 weeks |
| Feasibility: Patient Satisfaction | Patient satisfaction will be assessed by study coordinators at the end of the study. Patient satisfaction will be reported as a scalar variable from 0 to 5. | From study enrollment to end of study at 12 weeks |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008892 | Milk |
| D001628 | Beverages |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |