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CompletedNCT02917824Updated Sep 10, 2019

Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics

An interventional study of High-intensity IMT and Low-intensity IMT in Asthma, sponsored by Universidade Federal do Rio Grande do Norte. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-09-10.

Sponsored by Universidade Federal do Rio Grande do Norte · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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. The aim of this study is to investigate the training principles of intensity, specificity and reversibility of IMT in asthmatics.

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Conditions studied

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In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 29 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Universidade Federal do Rio Grande do Norte is the lead sponsor of 84 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of asthma
  • Adults (18 - 60 years)

Exclusion criteria

Exclusion Criteria:

  • Inability to perform the protocol established by the study
  • Others respiratory diseases
  • Request for study withdrawal
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    High-intensity IMT

    Participants enrolled in this arm received high-intensity IMT

    Device: High-intensity IMT

  • Active comparator
    Low-intensity IMT

    Participants enrolled in this arm received low-intensity IMT

    Device: Low-intensity IMT

Interventions

  • DeviceHigh-intensity IMT

    30 breaths at 50% of the maximal inspiratory pressure, twice daily for 6 weeks

  • DeviceLow-intensity IMT

    30 breaths at 15% of the maximal inspiratory pressure, twice daily for 6 weeks

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What researchers measure

Primary outcomes

  1. Change in inspiratory muscle strength

    Maximal inspiratory pressure

    Time frame: Baseline, 6 weeks later and 6 weeks after training

  2. Change in expiratory muscle strength

    Maximal expiratory pressure

    Time frame: Baseline, 6 weeks later and 6 weeks after training

Secondary outcomes

  1. 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)

    Time frame: Baseline, 6 weeks later and 6 weeks after training

  2. 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.

    Time frame: Baseline, 6 weeks later and 6 weeks after training

  3. Change in six minute walk test distance

    Six-minute walk test (6MWT)

    Time frame: Baseline, 6 weeks later and 6 weeks after training

  4. Change in forced vital capacity

    Forced vital capacity in litres and % of predicted

    Time frame: Baseline, 6 weeks later and 6 weeks after training

  5. Change in forced expiratory volume

    Forced expiratory volume in litres and % of predicted

    Time frame: Baseline, 6 weeks later and 6 weeks after training

  6. Change in forced expiratory volume/forced vital capacity

    Forced expiratory volume/forced vital capacity

    Time frame: Baseline, 6 weeks later and 6 weeks after training

  7. Change in inspiratory muscle activity

    Surface electromyography of inspiratory muscles

    Time frame: Baseline, 6 weeks later and 6 weeks after training

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Study locations

1 site
  • Gardenia Maria Holanda Ferreira
    Natal, Rio Grande Do Norte 59078-970, Brazil
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02917824
Lead sponsor
Universidade Federal do Rio Grande do Norte
Responsible party
Gardenia Maria Holanda Ferreira (Principal Investigator, Universidade Federal do Rio Grande do Norte) — Principal investigator
First posted
Sep 28, 2016
Start date
Nov 2016
Primary completion
Mar 2017
Completion
Mar 2017
Last update
Sep 10, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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