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

This study has been completed.
Sponsor:
Collaborator:
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Information provided by (Responsible Party):
Alejandro Lucia, Universidad Europea de Madrid
ClinicalTrials.gov Identifier:
NCT01706445
First received: October 9, 2012
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidad Europea de Madrid:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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).


Other Outcome Measures:
  • Maximal inspiratory pressure (PImax) [ Time Frame: september 2011-july 2012 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alejandro Lucia, MD PhD, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT01706445     History of Changes
Other Study ID Numbers: kid'strainingCF, CFtraining
Study First Received: October 9, 2012
Last Updated: October 11, 2012
Health Authority: Spain: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 21, 2013