Pulmonary Artery HypertensionNCT05056532
Evaluation of Respiratory Muscle in Patient With Pulmonary Arterial Hypertension
An observational study of Pulmonary Artery Hypertension, run by Giresun University at 1 site in Turkey (Türkiye).
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) Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Artery Hypertension
- What is being tested?
- patient assessment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2021to 18 Apr 2022
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patient group will be chosen among the admitted to clinic control group will consist of invited volunteers
Who may be able to join
- patients with diagnosis of pulmonary arterial hypertension
- patients with stabil drug therapy at least three months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul university-cerrahpasa cardiology institute
Istanbul, Haseki, 34096
About this study
Official title: 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)
- Conditions
- Pulmonary Artery Hypertension
- Being tested
- patient assessment
- Keywords
- respiratory muscle strength, exercise capacity, dyspnea, accessory respiratory muscle
- Medical subject headings
- Familial Primary Pulmonary Hypertension, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient assessmentDiagnostic test
subjective and objective measurement will be performed in patients with PAH
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: patient assessment | |
| 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 Receives: Diagnostic Test: patient assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pectoralis muscle strength
pectoralis muscle strength will be evaluated with hand held dynamometers according to muscle test technique
Measured: 15 minute
serratus anterior muscle strength
Serratus anterior muscle strength will be evaluated with hand held dynamometers according to muscle test technique
Measured: 15 minutes
sternocleidomasteoideus muscle strength
sternocleidomasteoideus muscle strength will be evaluated with hand held dynamometers according to muscle test technique
Measured: 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.
Measured: 15 minutes
Secondary outcomes (2)
Six Minute Walk Test (6MWT)
Six minute walk test will be performed to evalute functionally exercise capacity according to ATS/ERS guidelines
Measured: 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
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start9 Sep 2021
- Primary completion28 Mar 2022
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Artery HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Habibe DURDU, Principal investigator, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056532
- Sponsor's protocol ID
- PAH
- Status last verified
- May 2022
- First submitted
- 20 Sep 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26401245Riou 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.
PubMed 32028638
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Primary and Accessory Respiratory Muscles and Their Influence on Exercise Capacity and Dyspnea in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT05056532
- Acronym / sponsor ID
- PAH
- Conditions
- Pulmonary Artery Hypertension
- Keywords
- respiratory muscle strength, exercise capacity, dyspnea, accessory respiratory muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | Diagnostic Test: patient assessmentMaximal 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 |
| Control group | – | Diagnostic Test: patient assessmentMaximal 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patient group will be chosen among the admitted to clinic control group will consist of invited volunteers
Key inclusion criteria (2 listed)
- patients with diagnosis of pulmonary arterial hypertension
- patients with stabil drug therapy at least three months
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient assessmentsubjective and objective measurement will be performed in patients with PAH | Diagnostic test | Control group, patients |
Primary outcome
pectoralis muscle strength
Time frame: 15 minute
pectoralis muscle strength will be evaluated with hand held dynamometers according to muscle test technique
serratus anterior muscle strength
Time frame: 15 minutes
Serratus anterior muscle strength will be evaluated with hand held dynamometers according to muscle test technique
sternocleidomasteoideus muscle strength
Time frame: 15 minutes
sternocleidomasteoideus muscle strength will be evaluated with hand held dynamometers according to muscle test technique
Respiratory mouth pressure
Time frame: 15 minutes
Respiratory mouth pressure will be measured to determine maximally inspiratory pressure and maximally expiratory pressure according to ATS/ERS guidelines.
2 secondary outcomes
Six Minute Walk Test (6MWT)
Time frame: 30 minutes
Dyspnea assessment
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Background: PubMed 26401245Panagiotou 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.
- Background: PubMed 32028638Riou 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Habibe DURDU principal investigator
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Artery Hypertension, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pectoralis muscle strength (time frame: 15 minute). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05056532, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.