Clinical trial NCT04152187: Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension
Official title: Investigation of the Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pulmonary
Keywords: pulmonary hypertension
inspiratory muscle training
muscle weakness
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 6 minute walk test
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Mouth pressures
timeFrame: Change from Baseline at 8 weeks
measure: Modified Medical Research Council Dyspnea Scale
timeFrame: Change from Baseline at 8 weeks
measure: Forced vital capacity
timeFrame: Change from Baseline at 8 weeks
measure: Forced expiratory volume in 1 second
timeFrame: Change from Baseline at 8 weeks
measure: Diaphragma thickness
timeFrame: Change from Baseline at 8 weeks
measure: Levels of blood pressure
timeFrame: Change from Baseline at 8 weeks
measure: Arterial stiffness
timeFrame: Change from Baseline at 8 weeks
measure: Isometric muscle strength
timeFrame: Change from Baseline at 8 weeks
measure: Upper extremity exercise capacity
timeFrame: Change from Baseline at 8 weeks
measure: International Physical Activity Questionnaire-Short Form
timeFrame: Change from Baseline at 8 weeks
measure: Fatigue Impact Scale
timeFrame: Change from Baseline at 8 weeks
measure: Nottingham Health Profile
timeFrame: Change from Baseline at 8 weeks
measure: Changes in Anxiety and Depression
timeFrame: Change from Baseline at 8 weeks
measure: Changes in Dyspnea
timeFrame: Change from Baseline at 8 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylül University
Study officials:
affiliation: Dokuz Eylul University
name: Buse Ozcan Kahraman
role: PRINCIPAL_INVESTIGATOR
References: