Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension

• ClinicalTrials.gov Identifier: NCT04152187
• Recruitment Status: Completed
• First Posted: November 5, 2019
• Last Update Posted: November 15, 2022
• Sponsor: Dokuz Eylul University
• Information provided by (Responsible Party): Buse Ozcan Kahraman, Dokuz Eylul University

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.

Condition or disease	Intervention/treatment	Phase
Hypertension, Pulmonary	Other: Inspiratory muscle training	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Investigation of the Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension
• Actual Study Start Date: November 11, 2019
• Actual Primary Completion Date: August 18, 2022
• Actual Study Completion Date: October 18, 2022

Arms and Interventions

Arm	Intervention/treatment
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.
No Intervention: Control; No additional intervention

Outcome Measures

Primary Outcome Measures :

1. 6 minute walk test [ Time Frame: Change from Baseline at 8 weeks ]
   functional capacity

Secondary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Turkey

Dokuz Eylül University

Izmir, Turkey, 35320

Sponsors and Collaborators

Dokuz Eylul University

Investigators

• Principal Investigator: Buse Ozcan Kahraman; Dokuz Eylul University

More Information

• Responsible Party: Buse Ozcan Kahraman, Research Assistant, Dokuz Eylul University
• ClinicalTrials.gov Identifier: NCT04152187
• Other Study ID Numbers: Pulmonary Hypertension; 2018.KB.SAG.099 ( Other Grant/Funding Number: Dokuz Eylül University Scientific Research Coordination Unit )
• First Posted: November 5, 2019
• Last Update Posted: November 15, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Buse Ozcan Kahraman, Dokuz Eylul University:

pulmonary hypertension; inspiratory muscle training; muscle weakness

Additional relevant MeSH terms:

Hypertension, Pulmonary; Respiratory Aspiration; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes