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Trial record 50 of 45962 for:    intensity

Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics

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ClinicalTrials.gov Identifier: NCT02917824
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Gardenia Maria Holanda Ferreira, Universidade Federal do Rio Grande do Norte

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Device: High-intensity IMT Device: Low-intensity IMT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics: a Randomized Clinical Trial
Actual Study Start Date : November 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: High-intensity IMT
Participants enrolled in this arm received high-intensity IMT
Device: High-intensity IMT
30 breaths at 50% of the maximal inspiratory pressure, twice daily for 6 weeks

Active Comparator: Low-intensity IMT
Participants enrolled in this arm received low-intensity IMT
Device: Low-intensity IMT
30 breaths at 15% of the maximal inspiratory pressure, twice daily for 6 weeks




Primary Outcome Measures :
  1. Change in inspiratory muscle strength [ Time Frame: Baseline, 6 weeks later and 6 weeks after training ]
    Maximal inspiratory pressure

  2. Change in expiratory muscle strength [ Time Frame: Baseline, 6 weeks later and 6 weeks after training ]
    Maximal expiratory pressure


Secondary Outcome Measures :
  1. Change in asthma control [ Time Frame: Baseline, 6 weeks later and 6 weeks after training ]
    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)

  2. Change in quality of life [ Time Frame: Baseline, 6 weeks later and 6 weeks after training ]
    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.

  3. Change in six minute walk test distance [ Time Frame: Baseline, 6 weeks later and 6 weeks after training ]
    Six-minute walk test (6MWT)

  4. Change in forced vital capacity [ Time Frame: Baseline, 6 weeks later and 6 weeks after training ]
    Forced vital capacity in litres and % of predicted

  5. Change in forced expiratory volume [ Time Frame: Baseline, 6 weeks later and 6 weeks after training ]
    Forced expiratory volume in litres and % of predicted

  6. Change in forced expiratory volume/forced vital capacity [ Time Frame: Baseline, 6 weeks later and 6 weeks after training ]
    Forced expiratory volume/forced vital capacity

  7. Change in inspiratory muscle activity [ Time Frame: Baseline, 6 weeks later and 6 weeks after training ]
    Surface electromyography of inspiratory muscles



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917824


Locations
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Brazil
Gardenia Maria Holanda Ferreira
Natal, Rio Grande Do Norte, Brazil, 59078-970
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte

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Responsible Party: Gardenia Maria Holanda Ferreira, Principal Investigator, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT02917824     History of Changes
Other Study ID Numbers: 1.533.228
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes