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The Effect of Walking Exercises in Patients With Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT05189691
Recruitment Status : Recruiting
First Posted : January 12, 2022
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
Ayse Ucar, Necmettin Erbakan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Quality of Life Symptoms and Signs Behavioral: walking exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective randomized controlled clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : April 4, 2022
Estimated Primary Completion Date : October 25, 2022
Estimated Study Completion Date : October 25, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: behavior change and walking exercise
A nurse-led interview will be held about the health benefits of lifestyle change and regular physical activity, which are effective in all CV diseases.Initially starting with 10-15 minutes of physical activity, it will continue until it reaches a duration of 30 or 60 minutes, 3 times a week. The goal is to exceed the previous number of steps each time. A pedometer will be used to ensure regular follow-up and control, and the number of steps will be marked on the walking tracking chart. They will be told how to keep a record after each exercise. A weekly phone call will be made to motivate the patient and the researcher will be informed that they can call.Blood pressure measurement, BMI, Toronto AF Symptom Severity Scale, Short Form 36 (SF-36) scales and continuously recorded step counts will be evaluated at week 0, 4 and at the end of week 12.
Behavioral: walking exercise
Initially starting with 10-15 minutes of physical activity, it will continue until it reaches a duration of 30 or 60 minutes, 3 times a week. The goal is to exceed the previous number of steps each time. If they feel fatigue or palpitations during the day, they can do their exercises the next day. If there are complaints of shortness of breath/shortness of breath, chest pain, palpitation during walking, he should take a break from walking and rest. A pedometer will be used to ensure regular follow-up and control, and the number of steps will be marked on the walking tracking chart. They will be told how to keep a record after each exercise. A weekly phone call will be made to motivate the patient and the researcher will be informed that they can call.
Other Name: behavior change

No Intervention: behavior change
A nurse-led interview will be held about the health benefits of lifestyle change and regular physical activity, which are effective in all CV diseases.Blood pressure measurement, BMI, Toronto AF Symptom Severity Scale and Short Form 36 (SF-36) scales will be evaluated at week 0, 4 and at the end of week 12.



Primary Outcome Measures :
  1. Atrial Fibrillation Symptom Severity [ Time Frame: 4 weeks after the first assessment ]

    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.


  2. Quality of Life [ Time Frame: 4 weeks after the first assessment ]

    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.


  3. Atrial Fibrillation Symptom Severity [ Time Frame: 12 weeks after the first assessment ]

    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. Quality of Life [ Time Frame: 12 weeks after the first assessment ]

    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.



Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 4 weeks after the first assessment ]
    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.

  2. BMI [ Time Frame: 4 weeks after the first assessment ]
    As a result of behavioral change, there will be a relationship between walking exercises measured with a pedometer and BMI.

  3. Blood Pressure [ Time Frame: 12 weeks after the first assessment ]
    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. BMI [ Time Frame: 12 weeks after the first assessment ]
    As a result of behavioral change, there will be a relationship between walking exercises measured with a pedometer and BMI.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05189691


Contacts
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Contact: Ayşe UÇAR, MSC +905335506412 aucar@erbakan.edu.tr
Contact: Selda ARSLAN, Phd +905439253200 seldayarali@hotmail.com

Locations
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Turkey
Necmettin Erbakan University Recruiting
Konya, Meram, Turkey, 42090
Contact: Ayşe Uçar    +905335506412    akkolucar@gmail.com   
Sponsors and Collaborators
Necmettin Erbakan University
Investigators
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Study Director: Selda ARSLAN, Phd Necmettin Erbakan University Faculty of Nursing
Principal Investigator: Ayşe Uçar, MSC Necmettin Erbakan University Faculty of Nursing
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Responsible Party: Ayse Ucar, Lecturer, Necmettin Erbakan University
ClinicalTrials.gov Identifier: NCT05189691    
Other Study ID Numbers: 21149003
First Posted: January 12, 2022    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayse Ucar, Necmettin Erbakan University:
atrial fibrillation
behavior modification model (COM-B)
walking exercise
symptom severity
quality of life
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes