NCT07808307

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Sep 2026Jun 2027

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

August 27, 2026

Last Update Submit

September 7, 2026

Conditions

Keywords

Atrial FibrillationCatheter AblationCardiac TelerehabilitationRemote Exercise TrainingExercise CapacityCardiac Rehabilitation

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (23)

  • Muscle Strength

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

  • Handgrip Strength

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

  • 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

  • Arterial Stiffness-Augmentation Index (AIx)

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

  • Heart Rate Variability-SDNN

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

  • +18 more secondary outcomes

Study Arms (2)

Cardiac Telerehabilitation Group

EXPERIMENTAL

Participants 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.

Behavioral: Remotely Supervised Cardiac Telerehabilitation

Control Group

ACTIVE COMPARATOR

Participants 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.

Other: Usual Care and General Exercise Guidance

Interventions

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.

Control Group

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.

Cardiac Telerehabilitation Group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University Hospital

Izmir, Balçova, 35330, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hande CORUT, PhD Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will be blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 8, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

September 8, 2026

Record last verified: 2026-09

Locations