Gupta 2017.
Trial name or title | Effects of exercise intervention program on bone mineral accretion in children and adolescents with cystic fibrosis. |
Methods | RCT (stratified block randomization, allocation concealed using sequentially numbered, sealed, opaque envelopes, open label). Design: parallel. Single centre. Duration: 1 year. |
Participants | Total sample size: 30. Inclusion criteria: children with confirmed diagnosis of CF (sweat chloride ≥ 60 mEq/l on 2 or more occasions in a child with clinical features suggestive of CF), stable medical condition (not required IV antibiotics for last 1 month prior to enrolment), FEV1 ≥ 20%. Exclusion criteria: children unwilling to participate in the study; presence of any prior diagnosed musculoskeletal disorder such as rheumatoid arthritis, muscular dystrophy, chronic renal failure. Age minimum: 6 years. Age maximum: 18 years. Gender: both. |
Interventions | Intervention group: exercise program ‐ resistance exercise and plyometric jumping exercise, 1x daily, 3x a week for 1 year. Control group: no exercise program, continue with regular physical activity for 1 year. |
Outcomes |
Primary outcome Mean bone mineral density at 1 year. Secondary outcomes Lung function (FEV1 and FVC) at baseline, 3 months, 6 months, 9 months and at the end of 1 year. Exercise capacity at baseline and at the end of 1 year. CFQ‐R at baseline and at the end of year. |
Starting date | Date of first enrolment: 08 September 2012. |
Contact information | Sumita Gupta (Physiotherapist) All India Institute of Medical Sciences, Department of Pediatrics, AIIMS, Ansari Nagar,New Delhi, DELHI 110029, India. Email sumitabisoi@gmail.com Professor SK Kabra Department of Pediatrics, AIIMS, Ansari Nagar,New Delhi, DELHI 110029, India. Email: skkabra@hotmail.com |
Notes |