Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable asthma
Started Nov 2016
Shorter than P25 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2016
CompletedFirst Posted
Study publicly available on registry
September 28, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedSeptember 10, 2019
September 1, 2019
4 months
September 25, 2016
September 6, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Change in asthma control
Baseline, 6 weeks later and 6 weeks after training
Change in quality of life
Baseline, 6 weeks later and 6 weeks after training
Change in six minute walk test distance
Baseline, 6 weeks later and 6 weeks after training
Change in forced vital capacity
Baseline, 6 weeks later and 6 weeks after training
Change in forced expiratory volume
Baseline, 6 weeks later and 6 weeks after training
- +2 more secondary outcomes
Study Arms (2)
High-intensity IMT
EXPERIMENTALParticipants enrolled in this arm received high-intensity IMT
Low-intensity IMT
ACTIVE COMPARATORParticipants enrolled in this arm received low-intensity IMT
Interventions
30 breaths at 50% of the maximal inspiratory pressure, twice daily for 6 weeks
30 breaths at 15% of the maximal inspiratory pressure, twice daily for 6 weeks
Eligibility Criteria
You may qualify if:
- Diagnosis of asthma
- Adults (18 - 60 years)
You may not qualify if:
- Inability to perform the protocol established by the study
- Others respiratory diseases
- Request for study withdrawal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gardenia Maria Holanda Ferreira
Natal, Rio Grande do Norte, 59078-970, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 25, 2016
First Posted
September 28, 2016
Study Start
November 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
September 10, 2019
Record last verified: 2019-09