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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).
Full description
Methodology Study population: Children with liver disease fulfilling the conditions as per inclusion and exclusion criteria
Baseline parameters that will be recorded:
Calculation of frailty score:
Cut-off for frailty will be defined as frailty score >5 in children with liver disease.
Methodology for Frailty assessment:
Assessment of the 5 Fried Frailty Criteria would be performed at baseline in an ambulatory setting .The Fried Frailty assessment would be done in children with liver disease. The assessments will be typically performed by a combination of a doctor, dietician and physiotherapist.
Weakness-Grip strength would be measured using a handheld device, the Jamar Hand Dynamometer. The device would be squeezed 3 times by each hand, and the mean value of the recorded strength (in pounds) was taken as the final result and compared with standard values for age and sex. Slownessor endurance would be assessed by the 6-minute walk test (6-MWT). Children will use a standard hand wheel to capture the walked distance on a hard flat surface at their own pace. The covered distance expressed in meters (m) will be compared with standard values for sex and age. Shrinkage in children would be assessed by triceps skin fold thickness (TSF) measurements. TSF would be measured in triplicates by a dietician and the mean result was recorded in centimeters (cm) and compared with the Center for Disease Control age and sex normative values. Exhaustion-the Pediatric Quality of Life Inventory 4.0 Multidimensional Fatigue Scale, a validated pediatric questionnaire, would be used to assess fatigue. Diminished Physical activity-For children the age appropriate versions of the validated Modified Physical Activity Questionnaire (PAQ) (PAQ-A for children >13 years of age and PAQ-C for children< 13 yearof age will be used .
Along with routine investigations including Complete Blood counts, Liver function and Renal function test, PT-INR, serum Ammonia, the following investigations will also be done:
Following enrolment and those fulfilling inclusion criteria, patient will then be allocated into exercise with SMT or SMT alone group as per block randomization method. Exercise with SMT or SMT alone will be given for a period of 12 weeks. Patient will be followed up for a period of 12 weeks. At the end of 12 weeks, frailty score will be recalculated .Body composition analysis,myokines and hepatokines will be repeated after 12 weeks.
Occurrence of clinical events including new onset ascites, AKI, hepatic encephalopathy, upper GI bleed and overall hospital stay as well as mortality over 12 weeks and 6 months will be noted in both groups during this period and treated as per standard of care. These events will be defined as follows-
Acute Kidney Injury
As per KDIGO guidelines:
Hepatic encephalopathy: as per Modified West-Haven's criteria.
Grades of ascites Grade 1- ascites only detected by ultrasound Grade 2 -moderate ascites evident by distension of abdomen with shifting dullness Grade 3- gross/tense ascites with marked abdominal distension Study period: 2 years
Intervention (Study 2):
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:
Monitoring and assessment:
Patients will be followed up for a period of at least 3 months. Occurrence of clinical events including new onset ascites, AKI, hepatic encephalopathy, upper GI bleed, significant infections will be noted in both groups during this period and treated as per standard of care.
At the end of 12 weeks, frailty assessment will be repeated along with myokines and hepatokines, body composition analysis and anthropometric examination.
Adverse effects:
There are no expected adverse effects of exercise as seen in previous studies.
Stopping rule of study:
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46 participants in 2 patient groups
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Central trial contact
Dr Deepika Yadav, MD
Data sourced from clinicaltrials.gov
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