Pulmonary Artery Hypertension Clinical Trial
Official title:
Evaluation of Primary and Accessory Respiratory Muscles and Their Influence on Exercise Capacity and Dyspnea in Pulmonary Arterial Hypertension
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 |
Verified date | May 2022 |
Source | Giresun University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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)
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul university-cerrahpasa cardiology institute | Istanbul | Haseki |
Lead Sponsor | Collaborator |
---|---|
Giresun University |
Turkey,
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
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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