NCT01706445

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

10 months

First QC Date

October 9, 2012

Last Update Submit

October 11, 2012

Conditions

Cystic Fibrosis

Keywords

cystic fibrosisexercisechildrencardiorespiratory fitnessmuscle strengthpulmonary functionquality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • quality of life

    this outcome will be assessed up to 12 weeks

Other Outcomes (1)

  • Maximal inspiratory pressure (PImax)

    september 2011-july 2012

Study Arms (2)

Control

NO INTERVENTION

intervention

OTHER

Exercise training

Other: Other

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

Also known as: Exercise training
intervention

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • boy/girl aged 6-17 years
  • living in the Madrid area

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

Cystic FibrosisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 15, 2012

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations

ES(1)