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The PEDALS stationary cycling intervention and health-related quality of life in children with cerebral palsy: a randomized controlled trial [with consumer summary]
Demuth SK, Knutson LM, Fowler EG
Developmental Medicine and Child Neurology 2012 Jul;54(7):654-661
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

AIM: The aim of this study was to assess health-related quality of life (HRQOL) following a stationary cycling intervention in children with cerebral palsy (CP). METHOD: This was a phase I multisite randomized controlled trial with single blinding. HRQOL was evaluated using the Pediatric Quality of Life Inventory SF15 (PedsQL; children) and Pediatric Outcomes Data Collection Instrument (PODCI; parent proxy) before and after a 3-month stationary cycling intervention. Sixty-two children (29 male, 33 female; mean age 11 y; range 7 to 18 y) with spastic diplegic CP, classified as levels I to III on the Gross Motor Function Classification System, were enrolled. Paired and independent t-tests were used to evaluate within- and between-group differences respectively. RESULTS: Between-group differences, favoring the cycling group, were found for PedsQL emotional functioning (p = 0.046) and Parental PODCI treatment expectations scores (p = 0.006). Between-group differences were not found for other scales. Within-group improvements were found in the cycling group: PedsQL total score (+5.8; p = 0.006), psychosocial health summary (+6.9; p = 0.008), and school functioning (+8.0; p = 0.038). PODCI satisfaction with symptoms decreased significantly only in the control group (-12.0; p = 0.046). INTERPRETATION: A beneficial influence of exercise on pediatric emotional well-being and parental treatment expectations was found. The evidence was not strong for other aspects of HRQOL. Results support the positive relationship between physical fitness and emotional well-being in the general population. A child's perception is important when examining change in his or her emotional well-being due to intervention.

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