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Completed

NCT Number: NCT01706445

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).

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Key information

Conditions

Cystic Fibrosis Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Motor Activity Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Infantil Universitario Niño Jesús

Madrid, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  1. 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 outcomes

  1. Maximal inspiratory pressure (PImax)

    Time frame: september 2011-july 2012

    an indicator of the strength of inspiratory muscles

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Collaborators

  • Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Registry information

Important dates

Study start
2011
Primary completion
2012
First posted
Oct 15, 2012
Registry last updated
Oct 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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