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Completed

NCT Number: NCT02917824

Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gardenia Maria Holanda Ferreira

Natal, Rio Grande do Norte, 59078-970, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity IMT

Device

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

Low-intensity IMT

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Registry information

Official study title

Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics: a Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 28, 2016
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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