Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension
Investigation of the Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension
2 other identifiers
interventional
24
1 country
1
Brief Summary
This study aims to determine the possible effects of inspiratory muscle training on cardiovascular, respiratory, physical and psychosocial functions in patients with PH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Typical duration for not_applicable
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
November 2, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedStudy Start
First participant enrolled
November 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2022
CompletedNovember 15, 2022
November 1, 2022
2.8 years
November 2, 2019
November 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6 minute walk test
functional capacity
Change from Baseline at 8 weeks
Secondary Outcomes (14)
Mouth pressures
Change from Baseline at 8 weeks
Modified Medical Research Council Dyspnea Scale
Change from Baseline at 8 weeks
Forced vital capacity
Change from Baseline at 8 weeks
Forced expiratory volume in 1 second
Change from Baseline at 8 weeks
Diaphragma thickness
Change from Baseline at 8 weeks
- +9 more secondary outcomes
Study Arms (2)
Inspiratory muscle training (IMT)
EXPERIMENTALPatients will receive IMT for 30 min (15x2), 7 times per week for 8 weeks using inspiratory muscle trainer device (PowerBreathe). During training, patients will be instructed to maintain diaphragmatic breathing. Inspiratory load will be set at 40-60% of maximum inspiratory pressure. Each week, six training sessions will be held at home and a training session will be supervised with physiotherapist.
Control
NO INTERVENTIONNo additional intervention
Interventions
The treatment group will receive inspiratory muscle training.
Eligibility Criteria
You may qualify if:
- Diagnosis of Pulmonary Hypertension
- According to the New York Heart Association functional class II - III
- Cases receiving stable medication for 3 months
You may not qualify if:
- Conditions which can limit the assessments
- Severe ischemic heart disease
- Acute cor pulmonale
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dokuz Eylül University
Izmir, 35320, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Buse Ozcan Kahraman
Dokuz Eylul University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
November 2, 2019
First Posted
November 5, 2019
Study Start
November 11, 2019
Primary Completion
August 18, 2022
Study Completion
October 18, 2022
Last Updated
November 15, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share