Physical Prehabilitation With and Without Creatine/Whey Protein Supplementation Effects on Frailty In Patients With Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frailty
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of cirrhosis by ICD-10 code, liver biopsy, abdominal imaging, or transient elastography
- •Access to digital device and internet at home
- •Ability to provide written informed consent before any study-related activities
- •Ability to remain in study for at least 3 months
排除标准
- •Allergy to milk protein
- •On hemodialysis
- •No English language proficiency
- •Presence of condition or abnormality that in opinion of the Investigator will compromise safety of the patient or quality of the data
- •Concomitant severe underlying systemic illness that in the opinion of the Investigator would interfere with completion of study
- •Pregnant, breastfeeding, or intention of becoming pregnant during study time frame
研究组 & 干预措施
HEAL-ME and placebo supplementation
Patients within this arm will be administered the HEAL-ME digital app and placebo supplementation daily
干预措施: HEAL-ME digital app (Behavioral)
HEAL-ME and placebo supplementation
Patients within this arm will be administered the HEAL-ME digital app and placebo supplementation daily
干预措施: Placebo (Dietary Supplement)
HEAL-ME and creatine/whey protein supplementation
Patients within this arm will be administered the HEAL-ME digital app and whey protein/creatine combination supplementation daily
干预措施: HEAL-ME digital app (Behavioral)
HEAL-ME and creatine/whey protein supplementation
Patients within this arm will be administered the HEAL-ME digital app and whey protein/creatine combination supplementation daily
干预措施: Whey protein supplementation (Dietary Supplement)
HEAL-ME and creatine/whey protein supplementation
Patients within this arm will be administered the HEAL-ME digital app and whey protein/creatine combination supplementation daily
干预措施: Creatine supplementation (Dietary Supplement)
结局指标
主要结局
Frailty
时间窗: From enrollment to end of study at 12 weeks
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.
次要结局
- Feasibility: Completion Rate(From study enrollment to end of study at 12 weeks)
- Health-related quality of life (HRQOL)(From enrollment to end of study at 12 weeks)
- Self-Reported Physical Activity(From enrollment to end of study at 12 weeks)
- Sarcopenia(From enrollment to end of study at 12 weeks)
- Feasibility: Adherence Rate(From study enrollment to end of study at 12 weeks)
- Feasibility: Patient Satisfaction(From study enrollment to end of study at 12 weeks)