Evaluation of Respiratory Muscle in Patient With Pulmonary Arterial Hypertension

Evaluation of Primary and Accessory Respiratory Muscles and Their Influence on Exercise Capacity and Dyspnea in Pulmonary Arterial Hypertension

The aim of the study is that evaluation of basic and accessory respiratory muscles and their relationship of six minute walk test in patient with pulmonary arterial hypertension (PAH)

Study Overview

• Status: Completed
• Conditions: Pulmonary Artery Hypertension
• Intervention / Treatment: Diagnostic test: patient assessment

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Turkey
  • Haseki
    • Istanbul, Haseki, Turkey, 34096
      • Istanbul University-Cerrahpasa Cardiology Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patient group will be chosen among the admitted to clinic control group will consist of invited volunteers

Description

Inclusion Criteria:

• patients with diagnosis of pulmonary arterial hypertension
• patients with stabil drug therapy at least three months

Exclusion Criteria:

• patients with obstructive and/ or restrictive lung disease comorbidity
• severe orthopedic and/ or neurological comorbidity
• patients with heart failure
• patients with ischemic heart disease
• uncooperative patients

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients; Maximal mouth pressure will be evaluated for determine respiratory muscle strength, m. pectoralis, m. serratus anterior, m. sternocloideumasteoideus and quadriceps muscles strengths will be measured to evaluate accessory respiratory muscle strength, London chest activity of daily living scale will be done for assessment of dyspnea and six minute walk test will be used for determination of functionally capacity	Diagnostic test: patient assessment; subjective and objective measurement will be performed in patients with PAH
Control group; Maximal mouth pressure will be evaluated for determine respiratory muscle strength, m. pectoralis, m. serratus anterior, m. sternocloideumasteoideus and quadriceps muscles strengths will be measured to evaluate accessory respiratory muscle strength, London chest activity of daily living scale will be done for assessment of dyspnea and six minute walk test will be used for determination of functionally capacity	Diagnostic test: patient assessment; subjective and objective measurement will be performed in patients with PAH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pectoralis muscle strength	pectoralis muscle strength will be evaluated with hand held dynamometers according to muscle test technique	15 minute
serratus anterior muscle strength	Serratus anterior muscle strength will be evaluated with hand held dynamometers according to muscle test technique	15 minutes
sternocleidomasteoideus muscle strength	sternocleidomasteoideus muscle strength will be evaluated with hand held dynamometers according to muscle test technique	15 minutes
Respiratory mouth pressure	Respiratory mouth pressure will be measured to determine maximally inspiratory pressure and maximally expiratory pressure according to ATS/ERS guidelines.	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six Minute Walk Test (6MWT)	Six minute walk test will be performed to evalute functionally exercise capacity according to ATS/ERS guidelines	30 minutes
Dyspnea assessment	London Chest Activity of Daily Living Scale will be used to sensation of dyspnea during activity of daily living.The scale consists of four domains: self-care (four items), domestic (six items), physical (two items) and leisure (three items). In total, the scale consisting of 15 items scored of 0 to 5. 0 means that "I wouldn't do anyway" and 5 means that "Someone else does it for me". Higher values indicate greater limitation due to the dyspnea	20 minutes

Collaborators and Investigators

• Sponsor: Giresun University
• Investigators: Principal Investigator: Habibe DURDU, Giresun University

Publications and helpful links

General Publications

• Panagiotou M, Peacock AJ, Johnson MK. Respiratory and limb muscle dysfunction in pulmonary arterial hypertension: a role for exercise training? Pulm Circ. 2015 Sep;5(3):424-34. doi: 10.1086/682431.
• Riou M, Pizzimenti M, Enache I, Charloux A, Canuet M, Andres E, Talha S, Meyer A, Geny B. Skeletal and Respiratory Muscle Dysfunctions in Pulmonary Arterial Hypertension. J Clin Med. 2020 Feb 3;9(2):410. doi: 10.3390/jcm9020410.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Actual): March 28, 2022
• Study Completion (Actual): April 18, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: exercise capacity; respiratory muscle strength; dyspnea; accessory respiratory muscle
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension
• Other Study ID Numbers: PAH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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