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NCT Number: NCT07808307

Tele-Rehabilitation After Catheter Ablation in Patients With Atrial Fibrillation

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.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University Hospital

Izmir, Balçova, 35330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remotely Supervised Cardiac Telerehabilitation

Behavioral

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.

Usual Care and General Exercise Guidance

Other

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.

Primary outcomes

  1. 6 Minute Walk Test (6MWT) Distance

    Time frame: 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 outcomes

  1. Muscle Strength

    Time frame: 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.

  2. Handgrip Strength

    Time frame: 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.

  3. Arterial Stiffness-Carotid-Femoral Pulse Wave Velocity (cfPWV)

    Time frame: At baseline (1 week after catheter ablation) and within 1 week after completion of the 12-week intervention

    Carotid-Femoral Pulse Wave Velocity (cfPWV)

  4. Arterial Stiffness-Augmentation Index (AIx)

    Time frame: 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 (%).

  5. Heart Rate Variability-SDNN

    Time frame: 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.

  6. Heart Rate Variability - RMSSD

    Time frame: 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.

  7. Heart Rate Variability - Low-Frequency Power (LF)

    Time frame: 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.

  8. Heart Rate Variability - High-Frequency Power (HF)

    Time frame: 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.

  9. Heart Rate Variability - LF/HF Ratio

    Time frame: 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.

  10. Atrial Fibrillation-Specific Quality of Life

    Time frame: 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.

  11. Physical Activity Level

    Time frame: 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.

  12. HADS-Anxiety

    Time frame: 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.

  13. HADS - Depression

    Time frame: 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

  14. Cognitive Function

    Time frame: 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.

  15. Atrial Fibrillation Recurrence

    Time frame: 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.

  16. Telerehabilitation Program Adherence

    Time frame: 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%).

  17. M-CTSIB - Sway Index, Eyes Open on Firm Surface

    Time frame: 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.

  18. M-CTSIB - Sway Index, Eyes Closed on Firm Surface

    Time frame: 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.

  19. M-CTSIB - Sway Index, Eyes Open on Foam Surface

    Time frame: 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.

  20. M-CTSIB - Sway Index, Eyes Closed on Foam Surface

    Time frame: 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.

  21. Postural Stability - Overall Stability Index

    Time frame: 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.

  22. Postural Stability - Anterior/Posterior Stability Index

    Time frame: 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.

  23. Postural Stability - Medial/Lateral Stability Index

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hande CORUT, PhD Student

CONTACT

[email protected]

+90 0507 664 15 15

Sponsors and collaborators

Lead sponsor

Hande Cörüt

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Effects of Remotely Supervised Cardiac Tele-Rehabilitation in Patients With Atrial Fibrillation After Catheter Ablation: A Single-Blind Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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