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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01706445
First Posted: October 15, 2012
Last Update Posted: October 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Information provided by (Responsible Party):
Alejandro Lucia, Universidad Europea de Madrid
  Purpose
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 Intervention
Cystic Fibrosis Other: Other

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Alejandro Lucia, Universidad Europea de Madrid:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • quality of life [ Time Frame: 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:
  • Maximal inspiratory pressure (PImax) [ Time Frame: september 2011-july 2012 ]
    an indicator of the strength of inspiratory muscles


Enrollment: 20
Study Start Date: September 2011
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
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 Name: Exercise training

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706445


Locations
Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Sponsors and Collaborators
Universidad Europea de Madrid
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
  More Information

Responsible Party: Alejandro Lucia, MD PhD, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT01706445     History of Changes
Other Study ID Numbers: kid'strainingCF
CFtraining ( Registry Identifier: PS09/00194 )
First Submitted: October 9, 2012
First Posted: October 15, 2012
Last Update Posted: October 15, 2012
Last Verified: October 2012

Keywords provided by Alejandro Lucia, Universidad Europea de Madrid:
cystic fibrosis
exercise
children
cardiorespiratory fitness
muscle strength
pulmonary function
quality of life

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases