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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754360
• Other study ID #: bakircaymzeren01
• Status: Completed
• Start date: February 15, 2021
• Est. completion date: May 10, 2021

Study information

• Verified date: October 2021
• Source: Izmir Bakircay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: May 10, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Evaluation 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
• Evaluation of pulmonary function
Pulmonary function will be evaluated using basic spirometry and respiratory pressure meter.
• Evaluation of quality of life
Quality of life will be evaluated using Short Form-36 Questionnaire.
• Evaluation of physical activity level
Physical activity level will be evaluated using International Physical Activity Questionnaire Short Form

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa, Institute of Cardiology	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Bakircay University	Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline
Primary	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).	At baseline
Primary	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.	At baseline
Secondary	Forced Vital Capacity (FVC)	FVC will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)	At baseline
Secondary	Forced Expiratory Volume in 1 second (FEV1)	FEV1 will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)	At baseline
Secondary	Peak Expiratory Flow (PEF)	PEF will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)	At baseline
Secondary	Maximum inspiratory pressure (MIP)	MIP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)	At baseline
Secondary	Maximum expiratory pressure (MEP)	MEP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)	At baseline
Secondary	Short Form-36	Short Form-36 questionnaire will be used to measure quality of life.	At baseline
Secondary	International Physical Activity Questionnaire - Short Form	International Physical Activity Questionnaire - Short Form will be used to measure physical activity level	At baseline