NCT05056532

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

September 20, 2021

Last Update Submit

May 29, 2022

Conditions

Keywords

respiratory muscle strengthexercise capacitydyspneaaccessory respiratory muscle

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Six Minute Walk Test (6MWT)

    30 minutes

  • Dyspnea assessment

    20 minutes

Study Arms (2)

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

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

Interventions

patient assessmentDIAGNOSTIC_TEST

subjective and objective measurement will be performed in patients with PAH

Control grouppatients

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul university-cerrahpasa cardiology institute

Istanbul, Haseki, 34096, Turkey (Türkiye)

Location

Related 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.

    PMID: 26401245BACKGROUND
  • 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.

    PMID: 32028638BACKGROUND

MeSH Terms

Conditions

Familial Primary Pulmonary HypertensionDyspnea

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Habibe DURDU

    Giresun University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2021

First Posted

September 24, 2021

Study Start

September 9, 2021

Primary Completion

March 28, 2022

Study Completion

April 18, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations