Cystic FibrosisNCT01706445
Combined Inspiratory Muscle and 'Whole Muscle' Training in Children With Cystic Fibrosis
A study testing Other in people with Cystic Fibrosis, run by Universidad Europea de Madrid at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Other
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- boy/girl aged 6-17 years
- living in the Madrid area
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
The investigators hypothesized that the combined training program would significantly benefit most of the aforementioned variables (especially, primary outcomes).
- Conditions
- Cystic Fibrosis
- Being tested
- Other
- Keywords
- cystic fibrosis, exercise, children, cardiorespiratory fitness, muscle strength, pulmonary function, quality of life
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtherOther
Also called Exercise training
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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| intervention | Other | Exercise training Receives: Other: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: this outcome will be assessed up to 12 weeks
Secondary outcomes (1)
quality of life
children's QoL with the Spanish Version (1.0) of the Cystic Fibrosis Questionnaire-Revised (CFQ-R).
Measured: this outcome will be assessed up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startSep 2011
- Primary completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Responsible party
- Principal investigator, Alejandro Lucia, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706445
- Sponsor's protocol ID
- kid'strainingCF
- Other IDs
- CFtraining
- Status last verified
- Oct 2012
- First submitted
- 9 Oct 2012
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Inspiratory Muscle and 'Whole Muscle' Training in Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01706445
- Acronym / sponsor ID
- kid'strainingCF
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, exercise, children, cardiorespiratory fitness, muscle strength, pulmonary function, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| intervention | Other | Other: OtherExercise training |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- boy/girl aged 6-17 years
- living in the Madrid area
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtherAlso: Exercise traininginspiratory 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 | intervention |
Primary outcome
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
1 secondary outcome
quality of life
Time frame: this outcome will be assessed up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Other in people with Cystic Fibrosis, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiorespiratory fitness (VO2peak) (time frame: this outcome will be assessed up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2012.