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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Evaluation of functional impairment; Other: Evaluation of pulmonary function; Other: Evaluation of quality of life; Other: Evaluation of physical activity level

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 Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University-Cerrahpasa, Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients diagnosed with atrial fibrillation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Atrial fibrillation; Adult patients with atrial fibrillation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Izmir Bakircay University
• Collaborators: Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): May 10, 2021
• Study Completion (Actual): May 10, 2021

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 10, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Exercise capacity; Functional impairment; Cut-off value; Sit-to-stand test; Symptomatology; 6-min walk test
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: bakircaymzeren01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No