Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients With Nonalcoholic Steatohepatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of subjects that complete at least 50% of the exercise sessions
研究概览
简要总结
This study will be a pilot study to evaluate the feasibility, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program previously validated in patients with cirrhosis in patients with nonalcoholic steatohepatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Adults age >18 years
- •Evidence of NASH indicated by at least one of the following
- •Liver biopsy with evidence of steatohepatitis (NAS >=4) within 6 months of the screening interval or;
- •Historical Imaging study (e.g., ultrasound, CT, MRI) with hepatic steatosis and one of the following non-invasive tests within 6 months of the screening interval: i. FIB-4 >= 1.3 or; ii. NFS >= -1.44 or; iii. ELF >= 7.7 or; iv. VCTE kPa >=8 or; v. ARFI >=1.3 or; vi. FAST >= 0.35 or; vii. MRE kPa >=2.55 or; viii. MAST > 0.165 or;
- •Possession of a smartphone
排除标准
- •Active cardiac symptoms precluding participation in vigorous exercise
- •Active or recent participation in exercise training program within the last 90 days
- •Active or recent weight-loss supplement use within the last 90 days (does not include GLP-1 receptor agonist use)
- •Active illicit substance use
- •Cancer that is active
- •Cirrhosis
- •Exercise identified to be unsafe by study PI or EL-FIT mHealth program
- •Inability to provide informed consent
- •Inability to walk > 2 blocks
- •Institutionalized/prisoner
- •Other chronic liver disease (e.g., viral hepatitis)
研究组 & 干预措施
Application Useage Arm
Along with wearing their Fitbit daily, subjects will be asked to use El-Fit app to participant in daily exercise as much or a little as they want over the course of the study.
干预措施: Exercise Intervention with use of El-Fit App (Behavioral)
结局指标
主要结局
Number of subjects that complete at least 50% of the exercise sessions
时间窗: 8 weeks
The primary study endpoint is feasibility of the use of the application, which is defined as \>50% of subjects adhering to the exercise prescribed, defined as completing \>50% of the sessions.
次要结局
未报告次要终点
研究者
Justin Tondt
Assistant Professor of Family and Community Medicine and Public Health Sciences
Milton S. Hershey Medical Center