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Inspiratory Muscle Training in Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

inspiratory muscle training

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring pulmonary hypertension, inspiratory muscle training, functional capacity, physical activity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Pulmonary Hypertension,
NYHA functional class I-IV
MIP pressure <80 cm h2O

Exclusion Criteria:

COPD
Conditions which can limit the assessments
Insufficient cooperation

Sites / Locations

Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Inspiratory muscle training group

control group

Arm Description

Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with %30 MIP at home.

Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with 9 cmH2O pressure at home.

Outcomes

Primary Outcome Measures

mouth pressures

MIP and MEP

Secondary Outcome Measures

International Physical Activity Questionnaire-Short Form

Physical activity

Minnesota Living with Heart Failure Questionnaire

quality of life

Activity monitoring (Sense wear® Armband)

Metabolic holter

6 minute walking test

functional capacity

Full Information

NCT ID

NCT03385733

First Posted

December 21, 2017

Last Updated

February 28, 2018

Sponsor

Istanbul University

Collaborators

Biruni University

1. Study Identification

Unique Protocol Identification Number

NCT03385733

Brief Title

Inspiratory Muscle Training in Pulmonary Hypertension

Official Title

The Effects of Inspiratory Muscle Training on Exercise Capacity, Physical Activity and Quality of Life in Pulmonary Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

October 10, 2017 (Actual)

Primary Completion Date

February 15, 2018 (Actual)

Study Completion Date

February 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul University

Collaborators

Biruni University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life.

Detailed Description

Pulmonary hypertension (PH) is a condition which is seen with hemodynamic differences, pulmonary vascular resistance and right heart failure. Patients with pulmonary hypertension have, dyspnea, physical inactivity, reduced condition and respiratory muscle dysfunction. Aerobic exercise programs in patients with pulmonary hypertension are reported to result in improved exercise capacity and endurance of the patients, improvement in WHO functional class and quality of life, increased peak workload and increased peripheral muscle function. In recent years, few studies have investigated the efficacy of inspiratory muscle training in patients with PH.The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Hypertension

Keywords

pulmonary hypertension, inspiratory muscle training, functional capacity, physical activity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients will randomize into two groups as Group A: inspiratory muscle training, and Group B (control group)

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inspiratory muscle training group

Arm Type

Experimental

Arm Description

Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with %30 MIP at home.

Arm Title

control group

Arm Type

No Intervention

Arm Description

Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with 9 cmH2O pressure at home.

Intervention Type

Other

Intervention Name(s)

inspiratory muscle training

Intervention Description

The treatment group received IMT. Patients were trained using an inspiratory threshold-loading device

Primary Outcome Measure Information:

Title

mouth pressures

Description

MIP and MEP

Time Frame

10 minutes

Secondary Outcome Measure Information:

Title

International Physical Activity Questionnaire-Short Form

Description

Physical activity

Time Frame

10 minutes

Title

Minnesota Living with Heart Failure Questionnaire

Description

quality of life

Time Frame

15 minutes

Title

Activity monitoring (Sense wear® Armband)

Description

Metabolic holter

Time Frame

3 days

Title

6 minute walking test

Description

functional capacity

Time Frame

15 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Pulmonary Hypertension, NYHA functional class I-IV MIP pressure <80 cm h2O Exclusion Criteria: COPD Conditions which can limit the assessments Insufficient cooperation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Goksen Kuran Aslan

Organizational Affiliation

Istanbul University

Official's Role

Study Director

Facility Information:

Facility Name

Istanbul University

City

Istanbul

ZIP/Postal Code

34010

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Results of the study will share with other researchers

Learn more about this trial

Inspiratory Muscle Training in Pulmonary Hypertension

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