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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05549739
Other study ID # GO 20/298
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 23, 2022
Est. completion date November 2022

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate respiratory parameters and functional capacity in coronary artery patients.


Description:

Decreased pulmonary function as measured by forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), or peak expiratory flow (PEF) has been associated with an increased risk of cardiovascular mortality and morbidity. A low MIP value may generally indicate weak muscle strength and therefore be an indicator of general poor health. Respiratory muscle weakness and decreased respiratory muscle endurance affect exercise tolerance in individuals with chronic disease, including cardiovascular disease. Studies have supported the association of grip strength with frailty, physical activity, diabetes, functional limitation, nutritional status, metabolic syndrome, and mortality. The study will evaluate respiratory parameters and functional capacity in coronary artery patients.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date November 2022
Est. primary completion date November 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 41 Years to 75 Years
Eligibility Inclusion Criteria: - Patients with coronary artery disease - Volunteering to participate in the research Exclusion Criteria: - Having a musculoskeletal problem - Having unstable cardiac disease - Having chronic heart failure (NYHA III-IV) - A history of acute coronary syndrome or surgical revascularization less than 3 months ago - Having arrhythmia - Having the last stage of kidney disease - Having active myocarditis or pericarditis

Study Design


Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Six-minute-step test The number of steps the participant climbed up and down is recorded. Day 1
Primary Respiratory muscle strength Respiratory muscle strength will be evaluated using a mouth pressure device. Day 1
Primary Respiratory muscle endurance Respiratory muscle endurance will be evaluated using a constant load test. Day 1
Secondary Pulmonary functions Forced vital capacity (FVC), Forced expiratory volume at one second (FEV1), Peak expiratory flow (PEF) assessment via spirometry. Day 1
Secondary Hand grip strength Hand grip strength is evaluated by a hand dynamometer. Day 1
Secondary Functional Capasity The functional capacity is assessed with The Duke Activity Status Index (DASI). Day 1
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