Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension

NCT ID: NCT04152187

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2022-10-18

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.

Conditions

Hypertension, Pulmonary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Inspiratory muscle training (IMT)

Patients 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.

Group Type: EXPERIMENTAL

Inspiratory muscle training

Intervention Type: OTHER

The treatment group will receive inspiratory muscle training.

Control

No additional intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Inspiratory muscle training

The treatment group will receive inspiratory muscle training.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Buse Ozcan Kahraman

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Buse Ozcan Kahraman

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

Dokuz Eylül University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2018.KB.SAG.099

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pulmonary Hypertension

Identifier Type: -

Identifier Source: org_study_id