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Atrial Fibrillation (AF)NCT07808307

Tele-Rehabilitation After Catheter Ablation in Patients With Atrial Fibrillation

A study testing Remotely Supervised Cardiac Telerehabilitation in people with Atrial Fibrillation (AF), run by Hande Cörüt at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
Remotely Supervised Cardiac Telerehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteTurkey (Türkiye)
Study dates
Sep 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hande CORUT, PhD Student contact

+90 0507 664 15 15

handedincel@hotmail.com

Turkey (Türkiye)1 site
  • Dokuz Eylul University Hospital

    Izmir, Balçova, 35330

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Remotely Supervised Cardiac Telerehabilitation, Usual Care and General Exercise Guidance
Keywords
Atrial Fibrillation, Catheter Ablation, Cardiac Telerehabilitation, Remote Exercise Training, Exercise Capacity, Cardiac Rehabilitation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remotely Supervised Cardiac TelerehabilitationBehavioural

    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 GuidanceOther

    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.

Study groups in NCT07808307
Study groupRoleWhat they receive
Cardiac Telerehabilitation GroupExperimentalParticipants in this group will receive standard care plus a 12-week remotely supervised cardiac telerehabilitation 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.
Receives: Behavioral: Remotely Supervised Cardiac Telerehabilitation
Control GroupActive comparatorParticipants in this group 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.
Receives: Other: Usual Care and General Exercise Guidance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 Minute Walk Test (6MWT) Distance

    Distance walked during the 6-minute walk test, measured in meters, as an indicator of functional exercise capacity.

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

Secondary outcomes (23)
  1. Muscle Strength

    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.

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

  2. Handgrip Strength

    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.

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

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

    Carotid-Femoral Pulse Wave Velocity (cfPWV)

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

  4. Arterial Stiffness-Augmentation Index (AIx)

    Augmentation Index (AIx) will be assessed noninvasively using the SphygmoCor XCEL device and reported as a percentage (%).

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

  5. Heart Rate Variability-SDNN

    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.

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

  6. Heart Rate Variability - RMSSD

    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.

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

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

    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.

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

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

    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.

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

  9. Heart Rate Variability - LF/HF Ratio

    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.

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

  10. Atrial Fibrillation-Specific Quality of Life

    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.

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

  11. Physical Activity Level

    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.

    Measured: 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

  12. HADS-Anxiety

    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.

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

  13. HADS - Depression

    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

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

  14. Cognitive Function

    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.

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

  15. Atrial Fibrillation Recurrence

    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.

    Measured: Throughout the 12-week intervention period, when clinically indicated

  16. Telerehabilitation Program Adherence

    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%).

    Measured: Throughout the 12-week intervention period

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

  21. Postural Stability - Overall Stability Index

    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.

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

  22. Postural Stability - Anterior/Posterior Stability Index

    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.

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

  23. Postural Stability - Medial/Lateral Stability Index

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07808307
Sponsor's protocol ID
DEU-AF-TELEREHAB-01
Status last verified
Sep 2026
First submitted
27 Aug 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Spertus J, Dorian P, Bubien R, Lewis S, Godejohn D, Reynolds MR, Lakkireddy DR, Wimmer AP, Bhandari A, Burk C. Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):15-25. doi: 10.1161/CIRCEP.110.958033. Epub 2010 Dec 15.

    PubMed 21160035
  • Schaffarczyk M, Rogers B, Reer R, Gronwald T. Validity of the Polar H10 Sensor for Heart Rate Variability Analysis during Resting State and Incremental Exercise in Recreational Men and Women. Sensors (Basel). 2022 Aug 30;22(17):6536. doi: 10.3390/s22176536.

    PubMed 36081005
  • Misra S, Niazi K, Swayampakala K, Blackmon A, Lang M, Davenport E, Saxonhouse S, Fedor J, Powell B, Thompson J, Holshouser J, Mehta R. Outcomes of a Remote Cardiac Rehabilitation Program for Patients Undergoing Atrial Fibrillation Ablation: Pilot Study. JMIR Cardio. 2023 Dec 14;7:e49345. doi: 10.2196/49345.

    PubMed 38096021
  • Cai C, Bao Z, Wu N, Wu F, Sun G, Yang G, Chen M. A novel model of home-based, patient-tailored and mobile application-guided cardiac telerehabilitation in patients with atrial fibrillation: A randomised controlled trial. Clin Rehabil. 2022 Jan;36(1):40-50. doi: 10.1177/02692155211032372. Epub 2021 Jul 16.

    PubMed 34266323
  • Kato M, Ogano M, Mori Y, Kochi K, Morimoto D, Kito K, Green FN, Tsukamoto T, Kubo A, Takagi H, Tanabe J. Exercise-based cardiac rehabilitation for patients with catheter ablation for persistent atrial fibrillation: A randomized controlled clinical trial. Eur J Prev Cardiol. 2019 Dec;26(18):1931-1940. doi: 10.1177/2047487319859974. Epub 2019 Jul 5.

    PubMed 31272205

Questions about this trial

What is this clinical trial studying?

A study testing Remotely Supervised Cardiac Telerehabilitation in people with Atrial Fibrillation (AF), run by Hande Cörüt at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hande CORUT, PhD Student (+90 0507 664 15 15, handedincel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07808307, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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