Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: High-intensity IMT; Device: Low-intensity IMT

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inspiratory muscle strength	Maximal inspiratory pressure	Baseline, 6 weeks later and 6 weeks after training
Change in expiratory muscle strength	Maximal expiratory pressure	Baseline, 6 weeks later and 6 weeks after training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Baseline, 6 weeks later and 6 weeks after training
Change in six minute walk test distance	Six-minute walk test (6MWT)	Baseline, 6 weeks later and 6 weeks after training
Change in forced vital capacity	Forced vital capacity in litres and % of predicted	Baseline, 6 weeks later and 6 weeks after training
Change in forced expiratory volume	Forced expiratory volume in litres and % of predicted	Baseline, 6 weeks later and 6 weeks after training
Change in forced expiratory volume/forced vital capacity	Forced expiratory volume/forced vital capacity	Baseline, 6 weeks later and 6 weeks after training
Change in inspiratory muscle activity	Surface electromyography of inspiratory muscles	Baseline, 6 weeks later and 6 weeks after training

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 25, 2016
• First Submitted That Met QC Criteria: September 26, 2016
• First Posted (Estimate): September 28, 2016

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 1.533.228

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No