Coronary Artery DiseaseNCT05549739
Evaluation of Respiratory Parameters and Functional Capacity in Coronary Artery Patients
An observational study of Coronary Artery Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate respiratory parameters and functional capacity in coronary artery patients. Read more about this study
- Who is it for?
- Ages 41 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Sep 2022to Nov 2022
- How long will I take part?
- 1 Day
- 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 41 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are more than 40 years old and diagnosed with coronary artery disease.
Who may be able to join
- Patients with coronary artery disease
- Volunteering to participate in the research
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate respiratory parameters and functional capacity in coronary artery patients.
Read the detailed 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.
- Conditions
- Coronary Artery Disease
- Keywords
- respiratory function test, physical functional performance, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Individuals without cardiac and pulmonary disease | |
| Study Group | Individuals with coronary artery disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute-step test
The number of steps the participant climbed up and down is recorded.
Measured: Day 1
Respiratory muscle strength
Respiratory muscle strength will be evaluated using a mouth pressure device.
Measured: Day 1
Respiratory muscle endurance
Respiratory muscle endurance will be evaluated using a constant load test.
Measured: Day 1
Secondary outcomes (3)
Pulmonary functions
Forced vital capacity (FVC), Forced expiratory volume at one second (FEV1), Peak expiratory flow (PEF) assessment via spirometry.
Measured: Day 1
Hand grip strength
Hand grip strength is evaluated by a hand dynamometer.
Measured: Day 1
Functional Capasity
The functional capacity is assessed with The Duke Activity Status Index (DASI).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start23 Sep 2022
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Saklica, Hacettepe University
- Investigators
- Naciye Vardar-Yagli, PhD, Study director, Hacettepe UniversityHikmet Yorgun, PhD, Study director, Hacettepe UniversityAhmet Hakan Ates, PhD, Study chair, Hacettepe UniversityDilara Saklica, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549739
- Sponsor's protocol ID
- GO 20/298
- Status last verified
- Oct 2022
- First submitted
- 18 Sep 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respiratory Parameters and Functional Capacity in Coronary Artery Patients
- ClinicalTrials.gov ID
- NCT05549739
- Acronym / sponsor ID
- GO 20/298
- Conditions
- Coronary Artery Disease
- Keywords
- respiratory function test, physical functional performance, coronary artery disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 22 Sep 2022 (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 purpose of this study is to evaluate respiratory parameters and functional capacity in coronary artery patients.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Individuals without cardiac and pulmonary disease |
| Study Group | – | –Individuals with coronary artery disease |
Who may qualify
- Ages
- 41 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are more than 40 years old and diagnosed with coronary artery disease.
Key inclusion criteria (2 listed)
- Patients with coronary artery disease
- Volunteering to participate in the research
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Six-minute-step test
Time frame: Day 1
The number of steps the participant climbed up and down is recorded.
Respiratory muscle strength
Time frame: Day 1
Respiratory muscle strength will be evaluated using a mouth pressure device.
Respiratory muscle endurance
Time frame: Day 1
Respiratory muscle endurance will be evaluated using a constant load test.
3 secondary outcomes
Pulmonary functions
Time frame: Day 1
Hand grip strength
Time frame: Day 1
Functional Capasity
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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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.
Naciye Vardar-Yagli, PhD study director
Hacettepe University
Hikmet Yorgun, PhD study director
Hacettepe University
Ahmet Hakan Ates, PhD study chair
Hacettepe 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 Coronary Artery Disease, run by Hacettepe 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 7 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: status not confirmed, as of the sponsor's last update on 21 Oct 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?
Results are not available in the source record.
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?
Six-minute-step test (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2022.