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Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension

Primary Purpose

Hypertension, Pulmonary

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory muscle training
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring pulmonary hypertension, inspiratory muscle training, muscle weakness

Eligibility Criteria

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

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

Sites / Locations

  • Dokuz Eylül University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Inspiratory muscle training (IMT)

Control

Arm Description

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.

No additional intervention

Outcomes

Primary Outcome Measures

6 minute walk test
functional capacity

Secondary Outcome Measures

Mouth pressures
Maximal inspiratory pressure, maximal expiratory pressure and endurance will be measure with mouth pressure device
Modified Medical Research Council Dyspnea Scale
Modified Medical Research Council Dyspnea Scale is used to measure dyspnea. Higher scores indicate higher dyspnea.
Forced vital capacity
Forced vital capacity is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Forced expiratory volume in 1 second
The volume of air expired in the first second of expiration or forced expiratory volume in 1 second, especially when expressed as a ratio with the total amount of air expired during the forced vital capacity, is a good index of expiratory airways resistance.
Diaphragma thickness
Diaphragma thickness will be measured by two dimensional ultrasonography
Levels of blood pressure
Ambulatory blood pressure monitoring will be used for blood pressure measurement
Arterial stiffness
During blood pressure measurements, augmentation index will be measured by non-invasive oscillations over the brachial artery.
Isometric muscle strength
Isometric muscle strength for knee extensors and shoulder flexors and abductors
Upper extremity exercise capacity
Upper extremity exercise capacity will be measured with Six-Minute Pegboard and Ring Test. In this test 4 iron rods, and a total of 20 rings are placed on a pegboard. At the end of six minutes, total number of rings placed will count.
International Physical Activity Questionnaire-Short Form
The International Physical Activity Questionnaire-Short Form has 7 items listing activities and requests estimates of durations and frequencies for each activity engaged in over the past week. Durations are multiplied by known metabolic equivalents per activity and the results for all items are summed for the overall physical activity score. Scores for walking and for moderate and vigorous activities are sums of corresponding item scores. Higher scores indicate higher physical activity level.
Fatigue Impact Scale
The Fatigue Impact Scale is widely used to measure fatigue. It is a 40-item multidimensional scale measuring the physical, cognitive and social. Patients are asked to rate how much of a problem fatigue has caused them during the past month, including the day of testing, on a 5-point Likert-type scale, with response options ranging from 0 "no problem" to 4 "extreme problem". Loer scores indicate the better results
Nottingham Health Profile
Health-related quality of life will be assessed using Nottingham Health Profile scale which is a general quality of life questionnaire that measures perceived health problems and their impact on normal daily activities. It has 38 items divided into six domains: energy level, pain, emotional reactions, sleep, social isolation and physical abilities. Items use yes/no answer format and each item is weighted. Total scores for each domain range from 0 to 100. Higher scores represent less quality of life in relevant domain.
Changes in Anxiety and Depression
Anxiety and depression levels will be assessed by Hospital Anxiety and Depression Scale. The scale consists of 14 items, seven items for the anxiety subscale and seven for the depression subscale. Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Higher scores indicate
Changes in Dyspnea
Dyspnea level will be questioned with the modified Borg Scale. Minimum value is 0 (no dyspnea), and maximum value is 10 (maximal dyspnea) Higher scores indicate higher fatigue levels.

Full Information

First Posted
November 2, 2019
Last Updated
November 14, 2022
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04152187
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
August 18, 2022 (Actual)
Study Completion Date
October 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
Keywords
pulmonary hypertension, inspiratory muscle training, muscle weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training (IMT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No additional intervention
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Intervention Description
The treatment group will receive inspiratory muscle training.
Primary Outcome Measure Information:
Title
6 minute walk test
Description
functional capacity
Time Frame
Change from Baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Mouth pressures
Description
Maximal inspiratory pressure, maximal expiratory pressure and endurance will be measure with mouth pressure device
Time Frame
Change from Baseline at 8 weeks
Title
Modified Medical Research Council Dyspnea Scale
Description
Modified Medical Research Council Dyspnea Scale is used to measure dyspnea. Higher scores indicate higher dyspnea.
Time Frame
Change from Baseline at 8 weeks
Title
Forced vital capacity
Description
Forced vital capacity is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time Frame
Change from Baseline at 8 weeks
Title
Forced expiratory volume in 1 second
Description
The volume of air expired in the first second of expiration or forced expiratory volume in 1 second, especially when expressed as a ratio with the total amount of air expired during the forced vital capacity, is a good index of expiratory airways resistance.
Time Frame
Change from Baseline at 8 weeks
Title
Diaphragma thickness
Description
Diaphragma thickness will be measured by two dimensional ultrasonography
Time Frame
Change from Baseline at 8 weeks
Title
Levels of blood pressure
Description
Ambulatory blood pressure monitoring will be used for blood pressure measurement
Time Frame
Change from Baseline at 8 weeks
Title
Arterial stiffness
Description
During blood pressure measurements, augmentation index will be measured by non-invasive oscillations over the brachial artery.
Time Frame
Change from Baseline at 8 weeks
Title
Isometric muscle strength
Description
Isometric muscle strength for knee extensors and shoulder flexors and abductors
Time Frame
Change from Baseline at 8 weeks
Title
Upper extremity exercise capacity
Description
Upper extremity exercise capacity will be measured with Six-Minute Pegboard and Ring Test. In this test 4 iron rods, and a total of 20 rings are placed on a pegboard. At the end of six minutes, total number of rings placed will count.
Time Frame
Change from Baseline at 8 weeks
Title
International Physical Activity Questionnaire-Short Form
Description
The International Physical Activity Questionnaire-Short Form has 7 items listing activities and requests estimates of durations and frequencies for each activity engaged in over the past week. Durations are multiplied by known metabolic equivalents per activity and the results for all items are summed for the overall physical activity score. Scores for walking and for moderate and vigorous activities are sums of corresponding item scores. Higher scores indicate higher physical activity level.
Time Frame
Change from Baseline at 8 weeks
Title
Fatigue Impact Scale
Description
The Fatigue Impact Scale is widely used to measure fatigue. It is a 40-item multidimensional scale measuring the physical, cognitive and social. Patients are asked to rate how much of a problem fatigue has caused them during the past month, including the day of testing, on a 5-point Likert-type scale, with response options ranging from 0 "no problem" to 4 "extreme problem". Loer scores indicate the better results
Time Frame
Change from Baseline at 8 weeks
Title
Nottingham Health Profile
Description
Health-related quality of life will be assessed using Nottingham Health Profile scale which is a general quality of life questionnaire that measures perceived health problems and their impact on normal daily activities. It has 38 items divided into six domains: energy level, pain, emotional reactions, sleep, social isolation and physical abilities. Items use yes/no answer format and each item is weighted. Total scores for each domain range from 0 to 100. Higher scores represent less quality of life in relevant domain.
Time Frame
Change from Baseline at 8 weeks
Title
Changes in Anxiety and Depression
Description
Anxiety and depression levels will be assessed by Hospital Anxiety and Depression Scale. The scale consists of 14 items, seven items for the anxiety subscale and seven for the depression subscale. Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Higher scores indicate
Time Frame
Change from Baseline at 8 weeks
Title
Changes in Dyspnea
Description
Dyspnea level will be questioned with the modified Borg Scale. Minimum value is 0 (no dyspnea), and maximum value is 10 (maximal dyspnea) Higher scores indicate higher fatigue levels.
Time Frame
Change from Baseline at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buse Ozcan Kahraman
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylül University
City
Izmir
ZIP/Postal Code
35320
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension

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