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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01706445

Enrollment

Registered

2012-10-15

Start date

2011-09-30

Completion date

Unknown

Last updated

2012-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis, exercise, children, cardiorespiratory fitness, muscle strength, pulmonary function, quality of life

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).

Detailed description

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

Interventions

OTHEROther

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Measure	Time frame	Description
Maximal inspiratory pressure (PImax)	september 2011-july 2012	an indicator of the strength of inspiratory muscles

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026