Effect of Exercise Based Regimen on Frailty in Children With Liver Disease -A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Improvement in Frailty after 12 weeks of exercise therapy in children with CLD and Frailty.
研究概览
简要总结
Frailty is now a well-known complication of liver disease and various studies, including pediatric literature studies, have recognized it as a poor prognostic factor in CLD as well as liver transplant settings. It is associated with poor quality of life, increased hospitalisation and mortality. Exercise for >12 weeks leads to improvements in aerobic power (peak VO2), aerobic endurance, muscle mass and strength, health related quality of life (HRQoL)(1). Although effect of Exercise on sarcopenia and frailty has been studied extensively in cirrhotic adults, there is paucity of such literature on the effect of exercise on frailty in children. Through this study, we aim to assess efficacy of exercise-based regimen on frailty in children with chronic liver disease after 12 weeks. Our secondary objective will be to compare outcome between the two groups(frail and non frail children with liver disease) and to compare change in frailty scores between the two groups. Other objectives will include assessment of the body composition analysis and the myokines and hepatokines signatures of children with liver disease (pre and post exercise intervention).
详细描述
Methodology Study population: Children with liver disease fulfilling the conditions as per inclusion and exclusion criteria
Baseline parameters that will be recorded:
- Clinical parameters:
- History and etiology of liver disease
- Symptomatology, Evidence of decompensation (jaundice, organomegaly, encephalopathy, ascites, infections, variceal bleed etc)
- PELD, MELD Na score, Lansky play performance score
- Baseline laboratory parameters: Complete blood count, LFT, KFT, PT-INR, ammonia etc
- Imaging parameters: liver and spleen size, portal vein size etc
- Anthropometric parameters:
- Weight for age
- Height for age
- BMI
- Triceps skin fold thickness
- Subscapular fold thickness
- Mid arm circumference
Calculation of frailty score:
Cut-off for frailty will be defined as frailty score >5 in children 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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 9 - 18 years age with chronic liver disease & frailty score > 5.
排除标准
- •Lansky play performance scale <50
- •Unable to do exercise under supervision on at least 2 occasions
- •Children on higher corticosteroid dose (>0.1mg/kg/day) in last 12 weeks
- •Any degree of musculoskeletal involvement (myopathy/limb deformity/paraplegia)
- •Children with any cardiac disease
- •Children with neurological Wilson
- •Uncontrolled portal hypertension (persistent high-risk varices) Recurrent variceal bleed ≥ 2
- •Any degree of hemodynamic instability
- •Current hepatic encephalopathy (any grade)
- •Grade 3 ascites
- •Hepatic hydrothorax
- •Any degree of oxygen dependence
- •Severe or Very severe Hepatopulmonary syndrome (room air PaO2 < 60 mm Hg).
研究组 & 干预措施
Subject will receive 12 weeks of exercise with standard medical management (SMT)
- Subjects will be given exercise protocol Pre-exercise safety assessment: Careful assessment as per exclusion criteria; especially Portal Hypertension, Cardiopulmonary status etc
- Frequency: Aerobic and Resistance Exercises for total 50 minutes/day for 2-5 days per week (see protocol)
- Aerobic exercises consist of Brisk walking
- Resistance Exercises consist of movements targeting the major muscle groups with weight lifting
- Intensity:
Talk test: Short of breath but still can speak a full sentence Borg Scale: Keep between 5-6 out of 10.
- Time duration of aerobic exercise decided by 6MWT, and resistance exercise by Hand grip strength
- End point: 12 weeks
- Stopping rule:
- Interruption of Exercise for > 7 consecutive days due to non-compliance or clinical events.
- Progression to exclusion criteria i.e. decompensation etc
Both groups will be advised a calorie intake of 150cal/kg/day and protein intake of 3 gm/kg/day
干预措施: 12 weeks exercise (Other)
Subject will receive 12 weeks of exercise with standard medical management (SMT)
- Subjects will be given exercise protocol Pre-exercise safety assessment: Careful assessment as per exclusion criteria; especially Portal Hypertension, Cardiopulmonary status etc
- Frequency: Aerobic and Resistance Exercises for total 50 minutes/day for 2-5 days per week (see protocol)
- Aerobic exercises consist of Brisk walking
- Resistance Exercises consist of movements targeting the major muscle groups with weight lifting
- Intensity:
Talk test: Short of breath but still can speak a full sentence Borg Scale: Keep between 5-6 out of 10.
- Time duration of aerobic exercise decided by 6MWT, and resistance exercise by Hand grip strength
- End point: 12 weeks
- Stopping rule:
- Interruption of Exercise for > 7 consecutive days due to non-compliance or clinical events.
- Progression to exclusion criteria i.e. decompensation etc
Both groups will be advised a calorie intake of 150cal/kg/day and protein intake of 3 gm/kg/day
干预措施: Standard Medical Treatment (Other)
standard medical management (SMT)
standard medical management (SMT)
干预措施: Standard Medical Treatment (Other)
结局指标
主要结局
Improvement in Frailty after 12 weeks of exercise therapy in children with CLD and Frailty.
时间窗: 12 weeks
Improvement will be based on five fried fraility criteria with fraility score\> 5
Prevalence of Frailty in children with liver disease.
时间窗: 0 day
Fraility assessment criteria will be based on 5 elements: 1. weakness will be assessed by grip strength. 2. slowness will be by 6 minutes walk test. 3. shrinkage by triceps fold thickness. 4. exhaustion by validated pediatric PedsQL 4.0 multidiamential fatigue scale. 5. diminshed physical activity by modified PAQ
次要结局
- Decrease in the occurrence of significant events including Acute Kidney Injury in the exercise regimen with SMT group versus SMT alone .(3 months)
- Decrease in the occurrence of significant events including hospital stay in the exercise regimen with SMT group versus SMT alone .(3 months)
- Increase in skeletal muscle mass in Body composition analysis after 12 weeks of exercise regimen(12 weeks)
- Decrease in the occurrence of Upper Gastrointestinal bleed (presence or absence of GI bleed) in the exercise regimen with SMT group versus SMT alone.(3 months)
- Decrease in myostatin levels after 12 weeks of exercise regimen(12 weeks)
- Decrease in the occurrence of Hepatic Encephalopathy based on modified West Haven criteria in the exercise regimen with SMT group versus SMT alone.(3 months)
- Decrease in the occurrence of significant events including Spontaneous Bacterial Peritonitis in the exercise regimen with SMT group versus SMT alone .(3 months)
- Decrease in the occurrence of significant events including mortality in the exercise regimen with SMT group versus SMT alone .(3 months)
- Decrease in the occurrence of significant events including new onset or increase in ascites in the exercise regimen with SMT group versus SMT alone .(3 months)