Combined Inspiratory Muscle and 'Whole Muscle' Training in Children With Cystic Fibrosis
To study the effects of an 8-week combined inspiratory muscle training and exercise (resistance+aerobic) program on of a lung volume, inspiratory muscle strength (maximal inspiratory pressure, PImax) and cardiorespiratory fitness (maximal oxygen uptake, VO2peak) (primary outcomes)and dynamic muscle strength, body composition and quality of life (QoL) in children with Cystic Fibrosis (CF) (secondary outcomes).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
- cardiorespiratory fitness (VO2peak) [ Time Frame: this outcome will be assessed up to 12 weeks ] [ Designated as safety issue: No ]maximum oxygen uptake (VO2peak), which is the best indicator of aerobic fitness in humans and an independent mortality predictor in children with cystic fibrosis
- quality of life [ Time Frame: this outcome will be assessed up to 12 weeks ] [ Designated as safety issue: No ]children's QoL with the Spanish Version (1.0) of the Cystic Fibrosis Questionnaire-Revised (CFQ-R).
- Maximal inspiratory pressure (PImax) [ Time Frame: september 2011-july 2012 ] [ Designated as safety issue: No ]an indicator of the strength of inspiratory muscles
|Study Start Date:||September 2011|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|No Intervention: Control|
inspiratory muscle training (IMT) + aerobic and strength training 8-week duration IMT twice a day (mostly at home) + 3 weekly sessions of inhospital resistance + aerobic training
Other Name: Exercise training
The investigators hypothesized that the combined training program would significantly benefit most of the aforementioned variables (especially, primary outcomes).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706445
|Hospital Infantil Universitario Niño Jesús|