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Completed

NCT Number: NCT04152187

Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension

This study aims to determine the possible effects of inspiratory muscle training on cardiovascular, respiratory, physical and psychosocial functions in patients with PH.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training

Other

The treatment group will receive inspiratory muscle training.

Primary outcomes

  1. 6 minute walk test

    Time frame: Change from Baseline at 8 weeks

    functional capacity

Secondary outcomes

  1. Mouth pressures

    Time frame: Change from Baseline at 8 weeks

    Maximal inspiratory pressure, maximal expiratory pressure and endurance will be measure with mouth pressure device

  2. Modified Medical Research Council Dyspnea Scale

    Time frame: Change from Baseline at 8 weeks

    Modified Medical Research Council Dyspnea Scale is used to measure dyspnea. Higher scores indicate higher dyspnea.

  3. Forced vital capacity

    Time frame: Change from Baseline at 8 weeks

    Forced vital capacity is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.

  4. Forced expiratory volume in 1 second

    Time frame: Change from Baseline at 8 weeks

    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.

  5. Diaphragma thickness

    Time frame: Change from Baseline at 8 weeks

    Diaphragma thickness will be measured by two dimensional ultrasonography

  6. Levels of blood pressure

    Time frame: Change from Baseline at 8 weeks

    Ambulatory blood pressure monitoring will be used for blood pressure measurement

  7. Arterial stiffness

    Time frame: Change from Baseline at 8 weeks

    During blood pressure measurements, augmentation index will be measured by non-invasive oscillations over the brachial artery.

  8. Isometric muscle strength

    Time frame: Change from Baseline at 8 weeks

    Isometric muscle strength for knee extensors and shoulder flexors and abductors

  9. Upper extremity exercise capacity

    Time frame: Change from Baseline at 8 weeks

    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.

  10. International Physical Activity Questionnaire-Short Form

    Time frame: Change from Baseline at 8 weeks

    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.

  11. Fatigue Impact Scale

    Time frame: Change from Baseline at 8 weeks

    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

  12. Nottingham Health Profile

    Time frame: Change from Baseline at 8 weeks

    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.

  13. Changes in Anxiety and Depression

    Time frame: Change from Baseline at 8 weeks

    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

  14. Changes in Dyspnea

    Time frame: Change from Baseline at 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 5, 2019
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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