Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension

Investigation of the 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.

Study Overview

• Status: Completed
• Conditions: Hypertension, Pulmonary
• Intervention / Treatment: Other: Inspiratory muscle training

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35320
    • Dokuz Eylul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; No additional intervention
EXPERIMENTAL: 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.	Other: Inspiratory muscle training; The treatment group will receive inspiratory muscle training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk test	functional capacity	Change from Baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline at 8 weeks
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.	Change from Baseline at 8 weeks
Mouth pressures	Maximal inspiratory pressure, maximal expiratory pressure and endurance will be measure with mouth pressure device	Change from Baseline at 8 weeks
Modified Medical Research Council Dyspnea Scale	Modified Medical Research Council Dyspnea Scale is used to measure dyspnea. Higher scores indicate higher dyspnea.	Change from Baseline at 8 weeks
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.	Change from Baseline at 8 weeks
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.	Change from Baseline at 8 weeks
Diaphragma thickness	Diaphragma thickness will be measured by two dimensional ultrasonography	Change from Baseline at 8 weeks
Levels of blood pressure	Ambulatory blood pressure monitoring will be used for blood pressure measurement	Change from Baseline at 8 weeks
Arterial stiffness	During blood pressure measurements, augmentation index will be measured by non-invasive oscillations over the brachial artery.	Change from Baseline at 8 weeks
Isometric muscle strength	Isometric muscle strength for knee extensors and shoulder flexors and abductors	Change from Baseline at 8 weeks
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.	Change from Baseline at 8 weeks
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	Change from Baseline at 8 weeks
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	Change from Baseline at 8 weeks
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.	Change from Baseline at 8 weeks

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Principal Investigator: Buse Ozcan Kahraman, Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2019
• Primary Completion (ACTUAL): August 18, 2022
• Study Completion (ACTUAL): October 18, 2022

Study Registration Dates

• First Submitted: November 2, 2019
• First Submitted That Met QC Criteria: November 2, 2019
• First Posted (ACTUAL): November 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: muscle weakness; inspiratory muscle training; pulmonary hypertension
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Hypertension; Respiratory Aspiration; Hypertension, Pulmonary
• Other Study ID Numbers: pulmonary hypertension; 2018.KB.SAG.099 (OTHER_GRANT: Dokuz Eylül University Scientific Research Coordination Unit)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No