Atrial Fibrillation (AF)
Conditions
Keywords
Atrial Fibrillation, Catheter Ablation, Cardiac Telerehabilitation, Remote Exercise Training, Exercise Capacity, Cardiac Rehabilitation
Brief summary
This study aims to investigate the effects of remotely supervised cardiac telerehabilitation in patients with atrial fibrillation who have undergone catheter ablation. Participants will be randomly assigned to a cardiac telerehabilitation group or a control group. The telerehabilitation group will receive a 12-week remotely supervised exercise program in addition to standard care, consisting of aerobic, strengthening, and stretching exercises. The control group will receive standard care and general exercise guidance without an individualized exercise program. Functional exercise capacity, muscle strength, arterial stiffness, heart rate variability, quality of life, physical activity, balance, cognitive function, anxiety and depression, and atrial fibrillation recurrence will be evaluated.
Detailed description
This is a single-blind, randomized controlled study involving patients with atrial fibrillation who have undergone catheter ablation. Participants meeting the eligibility criteria will be informed about the study and will provide written informed consent before participation. Participants will be randomly allocated to either a remotely supervised cardiac telerehabilitation group or a control group. The cardiac telerehabilitation group will receive standard care plus a 12-week remotely supervised exercise program consisting of aerobic, strengthening, and stretching exercises. The program will be performed three days per week for a total of 36 sessions, with each session lasting approximately 45-60 minutes. Aerobic exercise will initially be performed at moderate intensity, corresponding to 40-60% of heart rate reserve according to the Karvonen method and a perceived exertion of 4-6 on the Modified Borg Scale. Exercise intensity and duration will be progressively increased according to individual tolerance. Strengthening exercises will be performed using elastic resistance bands, with exercise intensity monitored using the Modified Borg Scale. Exercise sessions will be conducted remotely by a physiotherapist using synchronous video-conferencing platforms or applications. Participants will use a Polar H10 chest heart rate sensor and a sports watch during exercise sessions. Exercise data will be uploaded to the PolarBeat platform and monitored remotely by the physiotherapist. The control group will receive standard care and general information regarding the benefits of exercise and appropriate physical activity recommendations. Participants in the control group will be encouraged to achieve 150 minutes of moderate physical activity per week but will not receive an individualized exercise training program. Assessments will include functional exercise capacity, muscle strength, handgrip strength, arterial stiffness, heart rate variability, anxiety and depression, atrial fibrillation-specific quality of life, physical activity, balance and fall risk, cognitive function, and atrial fibrillation recurrence. Adherence to the telerehabilitation program will also be recorded.
Interventions
BEHAVIORALRemotely Supervised Cardiac Telerehabilitation
A 12-week remotely supervised cardiac telerehabilitation exercise program consisting of aerobic, strengthening, and stretching exercises. Participants will exercise three days per week for a total of 36 sessions, with each session lasting approximately 45-60 minutes. Exercise intensity will be individually prescribed and progressed according to participant tolerance.
OTHERUsual Care and General Exercise Guidance
Participants will receive standard care and general exercise guidance. They will be encouraged to achieve 150 minutes of moderate physical activity per week but will not receive an individualized exercise training program.
Sponsors
Hande Cörüt
The Scientific and Technological Research Council of Turkey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will be blinded to group allocation.
Intervention model description
Participants will be randomly assigned to either a remotely supervised cardiac telerehabilitation group or a control group. The telerehabilitation group will receive a 12-week exercise program in addition to standard care, while the control group will receive standard care and general exercise guidance without an individualized exercise program.
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged 50-75 years. * Diagnosed with atrial fibrillation and treated with catheter ablation. * Have a smartphone or computer compatible with the digital equipment provided for the study. * Have access to the Internet. * Provide written informed consent to participate in the study.
Exclusion criteria
* Presence of a non-cardiovascular condition (orthopedic or neurological) that limits participation in exercise. * Acute heart failure, cancer, or worsening of a comorbid condition within the previous 3 months that may affect the assessment or intervention. * Severe cognitive impairment. * Unwillingness to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walk Test (6MWT) Distance | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Distance walked during the 6-minute walk test, measured in meters, as an indicator of functional exercise capacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Maximum isometric muscle strength will be assessed using a hand-held dynamometer. Bilateral knee extension, shoulder flexion, shoulder abduction, elbow flexion, and elbow extension strength will be measured; the best value will be recorded in kilograms. |
| Handgrip Strength | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Handgrip strength will be assessed using a Jamar hand dynamometer. Measurements will be performed three times for each hand at 5-second intervals, and the best value will be recorded in kilograms. |
| Arterial Stiffness-Carotid-Femoral Pulse Wave Velocity (cfPWV) | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Carotid-Femoral Pulse Wave Velocity (cfPWV) |
| Arterial Stiffness-Augmentation Index (AIx) | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Augmentation Index (AIx) will be assessed noninvasively using the SphygmoCor XCEL device and reported as a percentage (%). |
| Heart Rate Variability-SDNN | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | SDNN(ms) will be assessed using a Polar H10 heart rate sensor and Kubios HRV software from a 3-minute resting recording obtained with the participant in the supine position. |
| Heart Rate Variability - RMSSD | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | RMSSD(ms) will be assessed using a Polar H10 heart rate sensor and Kubios HRV software from a 3-minute resting recording obtained with the participant in the supine position. |
| Heart Rate Variability - Low-Frequency Power (LF) | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Low-frequency (LF) power(ms²) will be assessed using a Polar H10 heart rate sensor and Kubios HRV software from a 3-minute resting recording obtained with the participant in the supine position. |
| Heart Rate Variability - High-Frequency Power (HF) | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | High-frequency (HF) power(ms²) will be assessed using a Polar H10 heart rate sensor and Kubios HRV software from a 3-minute resting recording obtained with the participant in the supine position. |
| Heart Rate Variability - LF/HF Ratio | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | The LF/HF ratio will be calculated using Kubios HRV software from a 3-minute resting recording obtained with the participant in the supine position. |
| Atrial Fibrillation-Specific Quality of Life | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | The Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) will be used to assess atrial fibrillation-specific health-related quality of life. The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life. |
| Physical Activity Level | During the first 7 days after baseline assessment (1 week after catheter ablation) and during the final 7 days after completion of the 12-week intervention | Physical activity level will be objectively assessed using a pedometer. Participants will wear the sensor during all waking hours, except during showering and swimming, for 7 consecutive days. Daily step counts and sensor wearing times will be recorded in an activity diary. Physical activity will be assessed during the first 7 days after baseline assessment and during the final 7 days following completion of the 12-week intervention. |
| HADS-Anxiety | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | The anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A) will be used to assess anxiety symptoms. The score ranges from 0 to 21, with higher scores indicating greater anxiety symptom severity. |
| HADS - Depression | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | The depression subscale of the Hospital Anxiety and Depression Scale (HADS-D) will be used to assess depressive symptoms. The score ranges from 0 to 21, with higher scores indicating greater depressive symptom severity |
| Cognitive Function | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA evaluates attention and concentration, executive functions, memory, language, visuospatial skills, abstraction, calculation, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. |
| Atrial Fibrillation Recurrence | Throughout the 12-week intervention period, when clinically indicated | Atrial fibrillation recurrence will be assessed by a cardiologist using 12-lead electrocardiography and 24-hour Holter monitoring. Atrial fibrillation recurrence will be defined as documented atrial fibrillation lasting more than 30 seconds. |
| Telerehabilitation Program Adherence | Throughout the 12-week intervention period | Adherence to the telerehabilitation program will be calculated as the percentage of completed exercise sessions out of the 36 prescribed sessions. Participants will be categorized according to session attendance as adherent (\>80%), partially adherent (20%-80%), or non-adherent (\<20%). |
| M-CTSIB - Sway Index, Eyes Open on Firm Surface | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Sway Index will be assessed during the eyes-open condition on a firm surface using the Modified Clinical Test of Sensory Interaction on Balance (M-CTSIB) performed on the Biodex Balance System. Higher Sway Index values indicate greater postural sway and poorer postural stability. |
| M-CTSIB - Sway Index, Eyes Closed on Firm Surface | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Sway Index will be assessed during the eyes-closed condition on a firm surface using the Modified Clinical Test of Sensory Interaction on Balance (M-CTSIB) performed on the Biodex Balance System. Higher Sway Index values indicate greater postural sway and poorer postural stability. |
| M-CTSIB - Sway Index, Eyes Open on Foam Surface | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Sway Index will be assessed during the eyes-open condition on a foam surface using the Modified Clinical Test of Sensory Interaction on Balance (M-CTSIB) performed on the Biodex Balance System. Higher Sway Index values indicate greater postural sway and poorer postural stability. |
| M-CTSIB - Sway Index, Eyes Closed on Foam Surface | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Sway Index will be assessed during the eyes-closed condition on a foam surface using the Modified Clinical Test of Sensory Interaction on Balance (M-CTSIB) performed on the Biodex Balance System. Higher Sway Index values indicate greater postural sway and poorer postural stability. |
| Postural Stability - Overall Stability Index | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Overall Stability Index will be assessed using the Postural Stability Test performed on the Biodex Balance System. Higher values indicate greater postural sway and poorer postural stability. |
| Postural Stability - Anterior/Posterior Stability Index | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Anterior/Posterior Stability Index will be assessed using the Postural Stability Test performed on the Biodex Balance System. Higher values indicate greater anterior-posterior postural sway and poorer postural stability. |
| Postural Stability - Medial/Lateral Stability Index | At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention | Medial/Lateral Stability Index will be assessed using the Postural Stability Test performed on the Biodex Balance System. Higher values indicate greater medial-lateral postural sway and poorer postural stability. |
Countries
Turkey (Türkiye)
Contacts
CONTACTHande CORUT, PhD Student
Outcome results
None listed