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Clinical Trials/NCT04152187
NCT04152187
Completed
Not Applicable

Investigation of the Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension

Dokuz Eylul University1 site in 1 country24 target enrollmentNovember 11, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension, Pulmonary
Sponsor
Dokuz Eylul University
Enrollment
24
Locations
1
Primary Endpoint
6 minute walk test
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed Description

Pulmonary Hypertension (PH) is a hemodynamic finding related to increase in pulmonary artery pressure. Because PH disease is a progressive, rare disease, it is important for this disease group to prolong the life span and to increase the quality of life and functional capacity. PH patients have been shown to have weakness in peripheral and respiratory muscles. Patients will be randomly assigned to the inspiratory muscle training and control group. Inspiratory muscle training will be initiated in accordance with the patient at a range of 40-60%. İnspiratory muscle training will be given based on the assessments by the physiotherapist. Patients with PH who come to the routine outpatient clinic and volunteer will be included in the study. The first session will be the evaluation session and the 8-week inspiratory muscle training will be given, the other group will be the control group only. Dyspnoea, diaphragm thickness, pulmonary function, respiratory and peripheral muscle strength, blood pressure, arterial stiffness, physical activity, anxiety, depression and quality of life assessments will be repeated before and after the treatment.

Registry
clinicaltrials.gov
Start Date
November 11, 2019
End Date
October 18, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Buse Ozcan Kahraman

Research Assistant

Dokuz Eylul University

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of Pulmonary Hypertension
  • According to the New York Heart Association functional class II - III
  • Cases receiving stable medication for 3 months

Exclusion Criteria

  • Conditions which can limit the assessments
  • Severe ischemic heart disease
  • Acute cor pulmonale

Outcomes

Primary Outcomes

6 minute walk test

Time Frame: Change from Baseline at 8 weeks

functional capacity

Secondary Outcomes

  • 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)
  • Levels of blood pressure(Change from Baseline at 8 weeks)
  • Isometric muscle strength(Change from Baseline at 8 weeks)
  • Arterial stiffness(Change from Baseline at 8 weeks)
  • Upper extremity exercise capacity(Change from Baseline at 8 weeks)
  • International Physical Activity Questionnaire-Short Form(Change from Baseline at 8 weeks)
  • Fatigue Impact Scale(Change from Baseline at 8 weeks)
  • Nottingham Health Profile(Change from Baseline at 8 weeks)
  • Changes in Anxiety and Depression(Change from Baseline at 8 weeks)
  • Changes in Dyspnea(Change from Baseline at 8 weeks)

Study Sites (1)

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