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Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation

Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04754360
Enrollment
125
Registered
2021-02-15
Start date
2021-02-15
Completion date
2021-05-10
Last updated
2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Symptomatology, Functional impairment, Exercise capacity, 6-min walk test, Sit-to-stand test, Cut-off value

Brief 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.

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.

Interventions

OTHEREvaluation of functional impairment

Symptom burden and functional impairment will be evaluated with EHRA Score, 6-min walk test and 30-second sit-to-stand test

OTHEREvaluation of pulmonary function

Pulmonary function will be evaluated using basic spirometry and respiratory pressure meter.

Quality of life will be evaluated using Short Form-36 Questionnaire.

Physical activity level will be evaluated using International Physical Activity Questionnaire Short Form

Sponsors

Istanbul University - Cerrahpasa
CollaboratorOTHER
Izmir Bakircay University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

\- Diagnosis of paroxysmal, persistant or permanent atrial fibrillation

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The European Heart Rhythm Association (EHRA) scoreAt baselineFunctional 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 distanceAt baselineDistance 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 testAt baselineParticipants 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.

Secondary

MeasureTime frameDescription
Maximum inspiratory pressure (MIP)At baselineMIP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)
Maximum expiratory pressure (MEP)At baselineMEP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)
Forced Expiratory Volume in 1 second (FEV1)At baselineFEV1 will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)
International Physical Activity Questionnaire - Short FormAt baselineInternational Physical Activity Questionnaire - Short Form will be used to measure physical activity level
Short Form-36At baselineShort Form-36 questionnaire will be used to measure quality of life.
Forced Vital Capacity (FVC)At baselineFVC will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)
Peak Expiratory Flow (PEF)At baselinePEF will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026