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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05056532
Other study ID # PAH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 9, 2021
Est. completion date April 18, 2022

Study information

Verified date May 2022
Source Giresun University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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)


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date April 18, 2022
Est. primary completion date March 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
patient assessment
subjective and objective measurement will be performed in patients with PAH

Locations

Country Name City State
Turkey Istanbul university-cerrahpasa cardiology institute Istanbul Haseki

Sponsors (1)

Lead Sponsor Collaborator
Giresun University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. Review. — View Citation

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). pii: E410. doi: 10.3390/jcm9020410. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary pectoralis muscle strength pectoralis muscle strength will be evaluated with hand held dynamometers according to muscle test technique 15 minute
Primary serratus anterior muscle strength Serratus anterior muscle strength will be evaluated with hand held dynamometers according to muscle test technique 15 minutes
Primary sternocleidomasteoideus muscle strength sternocleidomasteoideus muscle strength will be evaluated with hand held dynamometers according to muscle test technique 15 minutes
Primary 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 Six Minute Walk Test (6MWT) Six minute walk test will be performed to evalute functionally exercise capacity according to ATS/ERS guidelines 30 minutes
Secondary 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
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