EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in PBC-40 Quality of Life for Primary Biliary Cirrhosis
研究概览
简要总结
A prospective, single centre, single-arm, pilot study investigating the safety and efficacy of a 12-week remotely-monitored home-based exercise program in patients with refractory fatigue (based on PBC-40 Quality of Life measure) secondary to Primary Biliary Cirrhosis.
详细描述
Recruitment from the research nurse-led PBC clinic: Eligibility screen followed by recruitment letters being sent to patients.
The outpatient clinic review by the liver specialist physiotherapist (week 0):
Patients will undergo a baseline assessment of quality of life, anthropometry, functional capacity (with validated tools including the incremental shuttle walk test and short performance battery test) and exercise tolerance. At the same visit, patients will be prescribed and trained to perform the individualised Home-based Exercise Program. Patients will be provided with an accelerometer to assess daily step count and a symptoms/side effects diary.
Six weeks of telephone support (weeks 0-6):
Patients will be telephoned weekly over a period of 6 weeks, in order to evaluate compliance with therapy and any difficulties encountered. At each phone call, the daily step count and the intensity of the resistance-exercises will be adjusted to the patients ability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •18 Years Old
- •A confirmed diagnosis of PBC through clinical observation as per guidance of BSG/ EASL
- •Fatigue Impact Scale >40
- •Access to a SMART Phone or Computer
排除标准
- •Decompensated PBC with the following clinical signs:
- •Moderate Ascites
- •A Bilirubin of >50
- •Variceal Bleed < 6 Months
- •Encephalopathic
- •Refractory Pruritis (Judged by PI)
- •Cardiovascular Instability (Judged by PI)
- •Untreated Vitamin Deficiency
- •Untreated hypothyroidism
- •Untreated Coeliac Disease
- •WHO Performance Status > 3
- •History of Unexplained Falls
结局指标
主要结局
Change in PBC-40 Quality of Life for Primary Biliary Cirrhosis
时间窗: 12 weeks
PBC-40 is a quality of life questionnaire (validated) with the domains of cognitive, social, emotional and overall symptom burden. 40 questions, each scored on a scale of 1 to 5 (where 1 = least impact, 5 = greatest impact)
次要结局
- hand grips strength (kg)(12 weeks)
- Health Anxiety Depression Score (HADS)(12 weeks)
- liver frailty index(12 weeks)
研究者
Matthew Armstrong
Consultant in Liver and Transplant Medicine, Honorary Clinical research Fellow and Principal Investigator
University of Birmingham