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Completed

NCT Number: NCT04754360

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 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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpasa, Institute of Cardiology

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of functional impairment

Other

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 function

Other

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

Evaluation of quality of life

Other

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

Evaluation of physical activity level

Other

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

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Secondary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: At baseline

    FVC will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)

  2. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: At baseline

    FEV1 will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)

  3. Peak Expiratory Flow (PEF)

    Time frame: At baseline

    PEF will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)

  4. Maximum inspiratory pressure (MIP)

    Time frame: At baseline

    MIP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)

  5. Maximum expiratory pressure (MEP)

    Time frame: At baseline

    MEP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)

  6. Short Form-36

    Time frame: At baseline

    Short Form-36 questionnaire will be used to measure quality of life.

  7. International Physical Activity Questionnaire - Short Form

    Time frame: At baseline

    International Physical Activity Questionnaire - Short Form will be used to measure physical activity level

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2021
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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