Cystic FibrosisNCT03737630
Inspiratory Muscle Training in Individuals With Cystic Fibrosis
A study testing Inspiratory muscle training in people with Cystic Fibrosis, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
Cystic fibrosis is a genetic disease that affects some organs of the human body. Among them, the lungs tend to be the most affected due to the accumulation of mucus in the airways, which in addition to avoiding the passage of air, favors pulmonary infections. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Aug 2019to 31 Jan 2020
- 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 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of cystic fibrosis, confirmed by the sweat test;
- 14 - 25 years;
- Clinical stability;
- Absence of bacterial colonization for 4 weeks;
- Both sexes;
Who cannot join
- Inability to perform the protocol established by the study;
- Present any intercurrence during data collection;
- Being unable to understand and / or perform procedures.
- Colonization during study participation;
- Patient hospitalization due to worsening of the clinical picture.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Norte
Natal, Rio Grande do Norte
About this study
Official title: Effects of Inspiratory Muscle Training in Individuals Who Have Cystic Fibrosis
Cystic fibrosis is a genetic disease that affects some organs of the human body. Among them, the lungs tend to be the most affected due to the accumulation of mucus in the airways, which in addition to avoiding the passage of air, favors pulmonary infections. With the evolution of the condition, secondary complications arise, such as postural changes, decreased respiratory muscle strength, decreased functional capacity and, consequently, quality of life. Therefore, respiratory muscle training may be an intervention that improves the respiratory condition of these individuals, allowing an improvement in the quality of life and may delay the evolution of respiratory symptoms. Thus, this study aims to investigate a home protocol of respiratory muscle training on respiratory muscle strength, lung function, quality of life, posture and functional capacity in adolescents and adults with cystic fibrosis. The researchers believe that the training can cause an improvement in the studied variables, and can be inserted in the usual treatment of these patients.
- Conditions
- Cystic Fibrosis
- Being tested
- Inspiratory muscle training
- Keywords
- cystic fibrosis, quality of life, posture
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingDevice
This group will initiate inspiratory muscle training with 40% of the MIP load and each week will have a load increase of 10% of the initial MIP up to 4 weeks of training
| Study group | Role | What they receive |
|---|---|---|
| GExp | Experimental | This group will perform the inspiratory muscle training with moderate load Receives: Device: Inspiratory muscle training |
| GCon | Active comparator | This group will initiate inspiratory muscle training with low load Receives: Device: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Posture at 4 weeks
Inclinometer Danoplus®
Measured: Baseline and after 4 weeks of training
Change from baseline Health-related quality of life at 4 weeks
Health-related quality of life questionnaire (HRQoL)
Measured: Baseline and after 4 weeks of training
Secondary outcomes (3)
Change from baseline Respiratory muscle strength at 4 weeks
MVD300®
Measured: Baseline and after 4 weeks of training
Change from baseline Pulmonary function at 4 weeks
Spirometry test using Koko® device
Measured: Baseline and after 4 weeks of training
Change from baseline Functional capacity at 4 weeks
three-minute step test
Measured: Baseline and after 4 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start5 Aug 2019
- Primary completion18 Oct 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patri-cia Angelica de Miranda Silva Nogueira, Universidade Federal do Rio Grande do Norte
- Investigators
- Victor Oliveira, Master, Study chair, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737630
- Sponsor's protocol ID
- 1a2b3c4d5e
- Status last verified
- Apr 2020
- First submitted
- 6 Nov 2018
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stanford G, Ryan H, Solis-Moya A. Respiratory muscle training for cystic fibrosis. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD006112. doi: 10.1002/14651858.CD006112.pub5.
PubMed 33331663
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training in Individuals Who Have Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03737630
- Acronym / sponsor ID
- 1a2b3c4d5e
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, quality of life, posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 9 Nov 2018 (actual)
- 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.
Cystic fibrosis is a genetic disease that affects some organs of the human body. Among them, the lungs tend to be the most affected due to the accumulation of mucus in the airways, which in addition to avoiding the passage of air, favors pulmonary infections. With the evolution of the condition, secondary complications arise, such as postural changes, decreased respiratory muscle strength, decreased functional capacity and, consequently, quality of life. Therefore, respiratory muscle training may be an intervention that improves the respiratory condition of these individuals, allowing an improvement in the quality of life and may delay the evolution of respiratory symptoms. Thus, this study aims to investigate a home protocol of respiratory muscle training on respiratory muscle strength, lung function, quality of life, posture and functional capacity in adolescents and adults with cystic fibrosis. The researchers believe that the training can cause an improvement in the studied variables, and can be inserted in the usual treatment of these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GExp | Experimental | Device: Inspiratory muscle trainingThis group will perform the inspiratory muscle training with moderate load |
| GCon | Active comparator | Device: Inspiratory muscle trainingThis group will initiate inspiratory muscle training with low load |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of cystic fibrosis, confirmed by the sweat test;
- 14 - 25 years;
- Clinical stability;
- Absence of bacterial colonization for 4 weeks;
- Both sexes;
Key exclusion criteria (5 listed)
- Inability to perform the protocol established by the study;
- Present any intercurrence during data collection;
- Being unable to understand and / or perform procedures.
- Colonization during study participation;
- Patient hospitalization due to worsening of the clinical picture.
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 |
|---|---|---|
| Inspiratory muscle trainingThis group will initiate inspiratory muscle training with 40% of the MIP load and each week will have a load increase of 10% of the initial MIP up to 4 weeks of training | Device | GCon, GExp |
Primary outcome
Change from baseline Posture at 4 weeks
Time frame: Baseline and after 4 weeks of training
Inclinometer Danoplus®
Change from baseline Health-related quality of life at 4 weeks
Time frame: Baseline and after 4 weeks of training
Health-related quality of life questionnaire (HRQoL)
3 secondary outcomes
Change from baseline Respiratory muscle strength at 4 weeks
Time frame: Baseline and after 4 weeks of training
Change from baseline Pulmonary function at 4 weeks
Time frame: Baseline and after 4 weeks of training
Change from baseline Functional capacity at 4 weeks
Time frame: Baseline and after 4 weeks of training
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 16 Apr 2020.
- Derived from this study: PubMed 33331663Stanford G, Ryan H, Solis-Moya A. Respiratory muscle training for cystic fibrosis. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD006112. doi: 10.1002/14651858.CD006112.pub5.
- Individual participant dataSharing planned: No
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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.
Victor Oliveira, Master study chair
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Cystic Fibrosis, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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 5 inclusion and 5 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 16 Apr 2020. 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 Brazil. 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?
Change from baseline Posture at 4 weeks (time frame: Baseline and after 4 weeks of training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03737630, which also lists 1 linked publication.
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 16 Apr 2020.