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

Sponsor
Universidad Europea de Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT01706445
Collaborator
Hospital Infantil Universitario Niño Jesús, Madrid, Spain (Other)
20
Enrollment
1
Location
2
Arms

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Other
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Jul 1, 2012

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control
Other: intervention

Exercise training

Other: Other
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 Names:
  • Exercise training

    		•

    Outcome Measures

    Primary Outcome Measures

    1. cardiorespiratory fitness (VO2peak) [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 Outcome Measures

    1. quality of life [this outcome will be assessed up to 12 weeks]

      children's QoL with the Spanish Version (1.0) of the Cystic Fibrosis Questionnaire-Revised (CFQ-R).

    Other Outcome Measures

    1. Maximal inspiratory pressure (PImax) [september 2011-july 2012]

      an indicator of the strength of inspiratory muscles

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Infantil Universitario Niño Jesús Madrid Spain

    Sponsors and Collaborators

    • Universidad Europea de Madrid
    • Hospital Infantil Universitario Niño Jesús, Madrid, Spain

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alejandro Lucia, MD PhD, Universidad Europea de Madrid
    ClinicalTrials.gov Identifier:
    NCT01706445
    Other Study ID Numbers:
    • kid'strainingCF
    • CFtraining
    First Posted:
    Oct 15, 2012
    Last Update Posted:
    Oct 15, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by Alejandro Lucia, MD PhD, Universidad Europea de Madrid
    cystic fibrosis
    exercise
    children
    cardiorespiratory fitness
    muscle strength
    pulmonary function
    quality of life
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of Oct 15, 2012