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

NCT ID: NCT01706445

Last Updated: 2012-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Brief Summary

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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

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

Conditions

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Cystic Fibrosis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention

Exercise training

Group Type OTHER

Other

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Exercise training

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Infantil Universitario Niño Jesús, Madrid, Spain

OTHER

Sponsor Role collaborator

Universidad Europea de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Alejandro Lucia

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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CFtraining

Identifier Type: REGISTRY

Identifier Source: secondary_id

kid'strainingCF

Identifier Type: -

Identifier Source: org_study_id