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

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706445
• Other study ID #: kid'strainingCF
• Secondary ID: CFtraining
• Status: Completed
• Phase: N/A
• First received: October 9, 2012
• Last updated: October 11, 2012
• Start date: September 2011

Study information

• Verified date: October 2012
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Infantil Universitario Niño Jesús	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Europea de Madrid	Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximal inspiratory pressure (PImax)	an indicator of the strength of inspiratory muscles	september 2011-july 2012	No
Primary	cardiorespiratory fitness (VO2peak)	maximum oxygen uptake (VO2peak), which is the best indicator of aerobic fitness in humans and an independent mortality predictor in children with cystic fibrosis	this outcome will be assessed up to 12 weeks	No
Secondary	quality of life	children's QoL with the Spanish Version (1.0) of the Cystic Fibrosis Questionnaire-Revised (CFQ-R).	this outcome will be assessed up to 12 weeks	No