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Clinical Trials/NCT01706445
NCT01706445
Completed
N/A

Combined Inspiratory Muscle and 'Whole Muscle' Training in Children With Cystic Fibrosis

Universidad Europea de Madrid1 site in 1 country20 target enrollmentSeptember 2011
ConditionsCystic Fibrosis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cystic Fibrosis
Sponsor
Universidad Europea de Madrid
Enrollment
20
Locations
1
Primary Endpoint
cardiorespiratory fitness (VO2peak)
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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).

Detailed Description

The investigators hypothesized that the combined training program would significantly benefit most of the aforementioned variables (especially, primary outcomes).

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
July 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Universidad Europea de Madrid
Responsible Party
Principal Investigator
Principal Investigator

Alejandro Lucia

MD PhD

Universidad Europea de Madrid

Eligibility Criteria

Inclusion Criteria

  • boy/girl aged 6-17 years
  • living in the Madrid area

Exclusion Criteria

  • severe lung deterioration \[forced expiratory volume (FEV1) \<50% of expected\]
  • unstable clinical condition (hospitalization within the previous 3 months)
  • Burkholderia cepacia infection
  • any disorder (e.g. muscle-skeletal) impairing exercise.

Outcomes

Primary Outcomes

cardiorespiratory fitness (VO2peak)

Time Frame: this outcome will be assessed up to 12 weeks

maximum oxygen uptake (VO2peak), which is the best indicator of aerobic fitness in humans and an independent mortality predictor in children with cystic fibrosis

Secondary Outcomes

  • quality of life(this outcome will be assessed up to 12 weeks)

Study Sites (1)

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