Atrial FibrillationNCT04754360
Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Cut-off values indicating higher symptom burden and impairment in health status in 6-min walk test and 30-second sit-to-stand test in patients with atrial fibrillation will be determined in the study. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Evaluation of functional impairment, Evaluation of pulmonary function and Evaluation of quality of life
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2021to 10 May 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with atrial fibrillation
Who may be able to join
- Diagnosis of paroxysmal, persistant or permanent atrial fibrillation
Who cannot join
- Diagnosis of heart failure or any chronic respiratory disease
- Recent coronary bypass surgery
- Previous heart valve surgery
- Rheumatic valvular heart disease
- Recent acute myocardial infarction
- Having a pacemaker
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Institute of Cardiology
Istanbul
About this study
Cut-off values indicating higher symptom burden and impairment in health status in 6-min walk test and 30-second sit-to-stand test in patients with atrial fibrillation will be determined in the study.
Read the detailed description
The 6-min walk test (6MWT) is the most used field test for measuring functional impairment in cardiopulmonary patients. However, to be able to objectively interpret 6MWT of a patient with specific chronic condition, the distance walked in 6MWT should be compared to either a healthy control group or a cut-off value that was specifically determined for that population. Such cut-off values are present for 6MWT in several cardiopulmonary diseases including COPD (350 m), heart failure (200 m) and pulmonary hypertension (400 m) for identifying patients with high mortality, poor prognosis and/or poor health status, but there is no cut-off value determined for atrial fibrillation (AF). The European Heart Rhythm Association (EHRA) score is a practical measure for assessing symptom burden and functional impairment caused by AF-related symptoms. While EHRA class 1 indicates asymptomatic patients, EHRA class 2, 3 and 4 indicates higher severities of symptom burden and functional impairment. Primary aim of this study is to determine a cut-off value in 6MWT for discriminating between the asymptomatic and symptomatic AF patients according to EHRA classification. In addition, a cut-off value for 30-second sit-to-stand test will be determined in these patients as well, since sit-to-stand tests have gained a lot of interest in the recent literature for practically evaluating functional status in various cardiopulmonary conditions.
- Conditions
- Atrial Fibrillation
- Being tested
- Evaluation of functional impairment, Evaluation of pulmonary function, Evaluation of quality of life, Evaluation of physical activity level
- Keywords
- Symptomatology, Functional impairment, Exercise capacity, 6-min walk test, Sit-to-stand test, Cut-off value
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of functional impairmentOther
Symptom burden and functional impairment will be evaluated with EHRA Score, 6-min walk test and 30-second sit-to-stand test
Evaluation of pulmonary functionOther
Pulmonary function will be evaluated using basic spirometry and respiratory pressure meter.
Evaluation of quality of lifeOther
Quality of life will be evaluated using Short Form-36 Questionnaire.
Evaluation of physical activity levelOther
Physical activity level will be evaluated using International Physical Activity Questionnaire Short Form
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation | Adult patients with atrial fibrillation Receives: Other: Evaluation of functional impairment; Other: Evaluation of pulmonary function; Other: Evaluation of quality of life; Other: Evaluation of physical activity level |
What is being measured
The primary outcome is the main question the study is designed to answer.
The European Heart Rhythm Association (EHRA) score
Functional impairment and symptom burden of the patients will be determined according to The European Heart Rhythm Association (EHRA) score. While EHRA class 1 indicates asymptomatic patients, EHRA class 2, 3 and 4 indicates higher severities of symptom burden and functional impairment, respectively.
Measured: At baseline
6-min walk distance
Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society (ATS).
Measured: At baseline
Number of repetitions in 30-second sit-to-stand test
Participants will be asked to perform sit-to-stand maneuver as fast as possible for 30 seconds and the number of completed repetitions will be recorded.
Measured: At baseline
Secondary outcomes (7)
Forced Vital Capacity (FVC)
FVC will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)
Measured: At baseline
Forced Expiratory Volume in 1 second (FEV1)
FEV1 will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)
Measured: At baseline
Peak Expiratory Flow (PEF)
PEF will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)
Measured: At baseline
Maximum inspiratory pressure (MIP)
MIP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)
Measured: At baseline
Maximum expiratory pressure (MEP)
MEP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)
Measured: At baseline
Short Form-36
Short Form-36 questionnaire will be used to measure quality of life.
Measured: At baseline
International Physical Activity Questionnaire - Short Form
International Physical Activity Questionnaire - Short Form will be used to measure physical activity level
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start15 Feb 2021
- Primary completion10 May 2021
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Melih Zeren, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754360
- Sponsor's protocol ID
- bakircaymzeren01
- Status last verified
- Oct 2021
- First submitted
- 10 Feb 2021
- Last updated
- 19 Oct 2021
- 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 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04754360
- Acronym / sponsor ID
- bakircaymzeren01
- Conditions
- Atrial Fibrillation
- Keywords
- Symptomatology, Functional impairment, Exercise capacity, 6-min walk test, Sit-to-stand test, Cut-off value
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 15 Feb 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.
Cut-off values indicating higher symptom burden and impairment in health status in 6-min walk test and 30-second sit-to-stand test in patients with atrial fibrillation will be determined in the study.
Detailed description
The 6-min walk test (6MWT) is the most used field test for measuring functional impairment in cardiopulmonary patients. However, to be able to objectively interpret 6MWT of a patient with specific chronic condition, the distance walked in 6MWT should be compared to either a healthy control group or a cut-off value that was specifically determined for that population. Such cut-off values are present for 6MWT in several cardiopulmonary diseases including COPD (350 m), heart failure (200 m) and pulmonary hypertension (400 m) for identifying patients with high mortality, poor prognosis and/or poor health status, but there is no cut-off value determined for atrial fibrillation (AF). The European Heart Rhythm Association (EHRA) score is a practical measure for assessing symptom burden and functional impairment caused by AF-related symptoms. While EHRA class 1 indicates asymptomatic patients, EHRA class 2, 3 and 4 indicates higher severities of symptom burden and functional impairment. Primary aim of this study is to determine a cut-off value in 6MWT for discriminating between the asymptomatic and symptomatic AF patients according to EHRA classification. In addition, a cut-off value for 30-second sit-to-stand test will be determined in these patients as well, since sit-to-stand tests have gained a lot of interest in the recent literature for practically evaluating functional status in various cardiopulmonary conditions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation | – | Other: Evaluation of functional impairment, Other: Evaluation of pulmonary function, Other: Evaluation of quality of life, Other: Evaluation of physical activity levelAdult patients with atrial fibrillation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with atrial fibrillation
Key inclusion criteria (1 listed)
- Diagnosis of paroxysmal, persistant or permanent atrial fibrillation
Key exclusion criteria (6 listed)
- Diagnosis of heart failure or any chronic respiratory disease
- Recent coronary bypass surgery
- Previous heart valve surgery
- Rheumatic valvular heart disease
- Recent acute myocardial infarction
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 |
|---|---|---|
| Evaluation of functional impairmentSymptom burden and functional impairment will be evaluated with EHRA Score, 6-min walk test and 30-second sit-to-stand test | Other | Atrial fibrillation |
| Evaluation of pulmonary functionPulmonary function will be evaluated using basic spirometry and respiratory pressure meter. | Other | Atrial fibrillation |
| Evaluation of quality of lifeQuality of life will be evaluated using Short Form-36 Questionnaire. | Other | Atrial fibrillation |
| Evaluation of physical activity levelPhysical activity level will be evaluated using International Physical Activity Questionnaire Short Form | Other | Atrial fibrillation |
Primary outcome
The European Heart Rhythm Association (EHRA) score
Time frame: At baseline
Functional impairment and symptom burden of the patients will be determined according to The European Heart Rhythm Association (EHRA) score. While EHRA class 1 indicates asymptomatic patients, EHRA class 2, 3 and 4 indicates higher severities of symptom burden and functional impairment, respectively.
6-min walk distance
Time frame: At baseline
Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society (ATS).
Number of repetitions in 30-second sit-to-stand test
Time frame: At baseline
Participants will be asked to perform sit-to-stand maneuver as fast as possible for 30 seconds and the number of completed repetitions will be recorded.
7 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: At baseline
Forced Expiratory Volume in 1 second (FEV1)
Time frame: At baseline
Peak Expiratory Flow (PEF)
Time frame: At baseline
Maximum inspiratory pressure (MIP)
Time frame: At baseline
Maximum expiratory pressure (MEP)
Time frame: At baseline
Short Form-36
Time frame: At baseline
International Physical Activity Questionnaire - Short Form
Time frame: At baseline
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 19 Oct 2021.
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Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atrial Fibrillation, run by Izmir Bakircay 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 1 inclusion and 6 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 19 Oct 2021. 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?
The European Heart Rhythm Association (EHRA) score (time frame: At baseline). 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 19 Oct 2021.