Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02917824
• Other study ID #: 1.533.228
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: March 2017

Study information

• Verified date: September 2019
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The aim of this study is to investigate the training principles of intensity, specificity and reversibility of IMT in asthmatics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Respiratory Aspiration

Intervention

Device:
• High-intensity IMT
30 breaths at 50% of the maximal inspiratory pressure, twice daily for 6 weeks
• Low-intensity IMT
30 breaths at 15% of the maximal inspiratory pressure, twice daily for 6 weeks

Locations

Country	Name	City	State
Brazil	Gardenia Maria Holanda Ferreira	Natal	Rio Grande Do Norte

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inspiratory muscle strength	Maximal inspiratory pressure	Baseline, 6 weeks later and 6 weeks after training
Primary	Change in expiratory muscle strength	Maximal expiratory pressure	Baseline, 6 weeks later and 6 weeks after training
Secondary	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
Secondary	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
Secondary	Change in six minute walk test distance	Six-minute walk test (6MWT)	Baseline, 6 weeks later and 6 weeks after training
Secondary	Change in forced vital capacity	Forced vital capacity in litres and % of predicted	Baseline, 6 weeks later and 6 weeks after training
Secondary	Change in forced expiratory volume	Forced expiratory volume in litres and % of predicted	Baseline, 6 weeks later and 6 weeks after training
Secondary	Change in forced expiratory volume/forced vital capacity	Forced expiratory volume/forced vital capacity	Baseline, 6 weeks later and 6 weeks after training
Secondary	Change in inspiratory muscle activity	Surface electromyography of inspiratory muscles	Baseline, 6 weeks later and 6 weeks after training