Atrial Fibrillation Clinical Trial
Official title:
The Effect of Walking Exercises Performed Using Behavior Change Model on Symptom Severity and Quality of Life in Patients With Atrial Fibrillation: A Randomized Controlled Trial
Verified date | May 2023 |
Source | Necmettin Erbakan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research will be carried out to determine the effect of walking exercises performed using a behavioral change model on symptom severity and quality of life in patients with Atrial Fibrillation.
Status | Completed |
Enrollment | 78 |
Est. completion date | February 17, 2023 |
Est. primary completion date | February 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Be between the ages of 18-75 - Volunteer - Sign the informed consent form - Diagnosed with AF - Speak and understand Turkish Exclusion Criteria: - Does not sign the informed consent form - Not being literate - Having cognitive and affective problems (vision, hearing impairment, delirium, dementia, depression, schizophrenia, bipolar disorder, etc.) - Having had a myocardial infarction in the last month, - Unstable clinical condition (uncontrolled cardiac arrhythmia, symptomatic severe aortic stenosis or other valvular disease, decompensated symptomatic heart failure and acute myocarditis or pericarditis), - Presence of disability that will prevent physical activity (Orthopedic reasons or other disabilities). |
Country | Name | City | State |
---|---|---|---|
Turkey | Necmettin Erbakan University | Konya | Meram |
Lead Sponsor | Collaborator |
---|---|
Necmettin Erbakan University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Atrial Fibrillation Symptom Severity | As a result of behavioral change, there will be a relationship between walking exercises measured with a pedometer and the University of Toronto Atrial Fibrillation Severity Scale (AFSS).Two separate scores are calculated on the scale: Atrial Fibrillation Burden and Atrial Fibrillation symptom severity:
Total Atrial Fibrillation Burden = Atrial Fibrillation frequency + Atrial Fibrillation duration + Atrial Fibrillation severity. Each of the 3 measurements contributes equally to the Total Atrial Fibrillation load, each scoring a score of 1-10 and thus the total Atrial Fibrillation load will score a score of 3-30. Higher scores indicate greater Atrial Fibrillation burden. Atrial Fibrillation symptom severity: The scores obtained from the questions in Part C are summed (between 0-5) to calculate the total score. The total score is between 0-35. This score is the symptom severity score, and a higher score indicates an increased Atrial Fibrillation symptom severity. |
4 weeks after the first assessment | |
Primary | Quality of Life with SF-36 | As a result of behavioral change, there will be a relationship between walking exercises measured by pedometer and RAND- 36 Item Short Form Survey Instrument (SF 36) score. SF-36 is a 36-item self-assessment scale consisting of eight subscales. This scale includes physical function (10 items), role limitations (physical (4 items)) and emotional problems (3 items), pain (2 items), vitality (4 items), social function (2 items), mental health (5 items)) and general health (5 items) subscales.
Each subscale is scored between 0-100, with "0" the lowest and "100" the best quality of life. |
4 weeks after the first assessment | |
Primary | Atrial Fibrillation Symptom Severity | As a result of behavioral change, there will be a relationship between walking exercises measured with a pedometer and the University of Toronto Atrial Fibrillation Severity Scale (AFSS).Two separate scores are calculated on the scale: Atrial Fibrillation Burden and Atrial Fibrillation symptom severity:
Total Atrial Fibrillation Burden = Atrial Fibrillation frequency + Atrial Fibrillation duration + Atrial Fibrillation severity. Each of the 3 measurements contributes equally to the Total Atrial Fibrillation load, each scoring a score of 1-10 and thus the total Atrial Fibrillation load will score a score of 3-30. Higher scores indicate greater Atrial Fibrillation burden. Atrial Fibrillation symptom severity: The scores obtained from the questions in Part C are summed (between 0-5) to calculate the total score. The total score is between 0-35. This score is the symptom severity score, and a higher score indicates an increased Atrial Fibrillation symptom severity. |
12 weeks after the first assessment | |
Primary | Quality of Life with SF-36 | As a result of behavioral change, there will be a relationship between walking exercises measured by pedometer and RAND- 36 Item Short Form Survey Instrument (SF 36) score. SF-36 is a 36-item self-assessment scale consisting of eight subscales. This scale includes physical function (10 items), role limitations (physical (4 items)) and emotional problems (3 items), pain (2 items), vitality (4 items), social function (2 items), mental health (5 items)) and general health (5 items) subscales.
Each subscale is scored between 0-100, with "0" the lowest and "100" the best quality of life. |
12 weeks after the first assessment | |
Secondary | Blood Pressure | As a result of behavioral change, there will be a relationship between walking exercises measured with a pedometer and systolic blood pressure and diastolic blood pressure. | 4 weeks after the first assessment | |
Secondary | BMI | As a result of behavioral change, there will be a relationship between walking exercises measured with a pedometer and BMI. | 4 weeks after the first assessment | |
Secondary | Blood Pressure | As a result of behavioral change, there will be a relationship between walking exercises measured with a pedometer and systolic blood pressure and diastolic blood pressure. | 12 weeks after the first assessment | |
Secondary | BMI | As a result of behavioral change, there will be a relationship between walking exercises measured with a pedometer and BMI. | 12 weeks after the first assessment |
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