The Effect of Walking Exercises in Patients With Atrial Fibrillation

NCT05189691 | Completed DMC

• 1 other identifier: 21149003
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Quality of Life; Symptoms and Signs

Keywords

atrial fibrillation; behavior modification model (COM-B); walking exercise; symptom severity; quality of life

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Blood Pressure

  4 weeks after the first assessment

• BMI

  4 weeks after the first assessment

• Blood Pressure

  12 weeks after the first assessment

• BMI

  12 weeks after the first assessment

Study Arms (2)

behavior change and walking exercise

EXPERIMENTAL

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

behavior change

NO INTERVENTION

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.

Interventions

walking exercise BEHAVIORAL

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.

Also known as: behavior change

behavior change and walking exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between the ages of 18-75
• Volunteer
• Sign the informed consent form
• Diagnosed with AF
• Speak and understand Turkish

You may not qualify if:

• 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).

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Atrial Fibrillation; Signs and Symptoms

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Selda ARSLAN, Phd

  Necmettin Erbakan University Faculty of Nursing

  STUDY DIRECTOR

• Ayşe Uçar, MSC

  Necmettin Erbakan University Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: January 12, 2022
• Study Start: April 4, 2022
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)