Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation
1 other identifier
observational
125
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2021
CompletedStudy Start
First participant enrolled
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2021
CompletedOctober 19, 2021
October 1, 2021
3 months
February 10, 2021
October 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (7)
Forced Vital Capacity (FVC)
At baseline
Forced Expiratory Volume in 1 second (FEV1)
At baseline
Peak Expiratory Flow (PEF)
At baseline
Maximum inspiratory pressure (MIP)
At baseline
Maximum expiratory pressure (MEP)
At baseline
- +2 more secondary outcomes
Study Arms (1)
Atrial fibrillation
Adult patients with atrial fibrillation
Interventions
Symptom burden and functional impairment will be evaluated with EHRA Score, 6-min walk test and 30-second sit-to-stand test
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
Eligibility Criteria
Adult patients diagnosed with atrial fibrillation
You may qualify if:
- \- Diagnosis of paroxysmal, persistant or permanent atrial fibrillation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Izmir Bakircay Universitylead
- Istanbul University - Cerrahpasacollaborator
Study Sites (1)
Istanbul University-Cerrahpasa, Institute of Cardiology
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof. Dr.
Study Record Dates
First Submitted
February 10, 2021
First Posted
February 15, 2021
Study Start
February 15, 2021
Primary Completion
May 10, 2021
Study Completion
May 10, 2021
Last Updated
October 19, 2021
Record last verified: 2021-10