AsthmaNCT02917824
Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics
A study testing High-intensity IMT and Low-intensity IMT in people with Asthma, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
Inspiratory muscle training (IMT) can reverse or delay the complications from the deterioration of inspiratory muscle function in asthma. Thus, the IMT has been considered a treatment option for people with asthma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- High-intensity IMT and Low-intensity IMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2016to Mar 2017
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of asthma
- Adults (18 - 60 years)
Who cannot join
- Inability to perform the protocol established by the study
- Others respiratory diseases
- Request for study withdrawal
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Gardenia Maria Holanda Ferreira
Natal, Rio Grande do Norte, 59078-970
About this study
Official title: Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics: a Randomized Clinical Trial
Inspiratory muscle training (IMT) can reverse or delay the complications from the deterioration of inspiratory muscle function in asthma. Thus, the IMT has been considered a treatment option for people with asthma. The aim of this study is to investigate the training principles of intensity, specificity and reversibility of IMT in asthmatics.
- Conditions
- Asthma
- Being tested
- High-intensity IMT, Low-intensity IMT
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity IMTDevice
30 breaths at 50% of the maximal inspiratory pressure, twice daily for 6 weeks
Low-intensity IMTDevice
30 breaths at 15% of the maximal inspiratory pressure, twice daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| High-intensity IMT | Experimental | Participants enrolled in this arm received high-intensity IMT Receives: Device: High-intensity IMT |
| Low-intensity IMT | Active comparator | Participants enrolled in this arm received low-intensity IMT Receives: Device: Low-intensity IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inspiratory muscle strength
Maximal inspiratory pressure
Measured: Baseline, 6 weeks later and 6 weeks after training
Change in expiratory muscle strength
Maximal expiratory pressure
Measured: Baseline, 6 weeks later and 6 weeks after training
Secondary outcomes (7)
Change in asthma control
Asthma Control Questionnaire measures the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. Scores range between 0 (totally controlled) and 6 (severely uncontrolled)
Measured: Baseline, 6 weeks later and 6 weeks after training
Change in quality of life
Asthma Quality of Life Questionnaire is a disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease. Scores range 1-7, with higher scores indicating better quality of life.
Measured: Baseline, 6 weeks later and 6 weeks after training
Change in six minute walk test distance
Six-minute walk test (6MWT)
Measured: Baseline, 6 weeks later and 6 weeks after training
Change in forced vital capacity
Forced vital capacity in litres and % of predicted
Measured: Baseline, 6 weeks later and 6 weeks after training
Change in forced expiratory volume
Forced expiratory volume in litres and % of predicted
Measured: Baseline, 6 weeks later and 6 weeks after training
Change in forced expiratory volume/forced vital capacity
Forced expiratory volume/forced vital capacity
Measured: Baseline, 6 weeks later and 6 weeks after training
Change in inspiratory muscle activity
Surface electromyography of inspiratory muscles
Measured: Baseline, 6 weeks later and 6 weeks after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gardenia Maria Holanda Ferreira, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917824
- Sponsor's protocol ID
- 1.533.228
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2016
- Last updated
- 10 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02917824
- Acronym / sponsor ID
- 1.533.228
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Sep 2016 (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.
Inspiratory muscle training (IMT) can reverse or delay the complications from the deterioration of inspiratory muscle function in asthma. Thus, the IMT has been considered a treatment option for people with asthma. The aim of this study is to investigate the training principles of intensity, specificity and reversibility of IMT in asthmatics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity IMT | Experimental | Device: High-intensity IMTParticipants enrolled in this arm received high-intensity IMT |
| Low-intensity IMT | Active comparator | Device: Low-intensity IMTParticipants enrolled in this arm received low-intensity IMT |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of asthma
- Adults (18 - 60 years)
Key exclusion criteria (3 listed)
- Inability to perform the protocol established by the study
- Others respiratory diseases
- Request for study withdrawal
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 |
|---|---|---|
| High-intensity IMT30 breaths at 50% of the maximal inspiratory pressure, twice daily for 6 weeks | Device | High-intensity IMT |
| Low-intensity IMT30 breaths at 15% of the maximal inspiratory pressure, twice daily for 6 weeks | Device | Low-intensity IMT |
Primary outcome
Change in inspiratory muscle strength
Time frame: Baseline, 6 weeks later and 6 weeks after training
Maximal inspiratory pressure
Change in expiratory muscle strength
Time frame: Baseline, 6 weeks later and 6 weeks after training
Maximal expiratory pressure
7 secondary outcomes
Change in asthma control
Time frame: Baseline, 6 weeks later and 6 weeks after training
Change in quality of life
Time frame: Baseline, 6 weeks later and 6 weeks after training
Change in six minute walk test distance
Time frame: Baseline, 6 weeks later and 6 weeks after training
Change in forced vital capacity
Time frame: Baseline, 6 weeks later and 6 weeks after training
Change in forced expiratory volume
Time frame: Baseline, 6 weeks later and 6 weeks after training
Change in forced expiratory volume/forced vital capacity
Time frame: Baseline, 6 weeks later and 6 weeks after training
Change in inspiratory muscle activity
Time frame: Baseline, 6 weeks later and 6 weeks after 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 10 Sep 2019.
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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 High-intensity IMT and Low-intensity IMT in people with Asthma, 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 2 inclusion and 3 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 10 Sep 2019. 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 in inspiratory muscle strength (time frame: Baseline, 6 weeks later and 6 weeks after 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?
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 10 Sep 2019.