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High-Intensity Interval Training prior to Pulmonary Vein Ablation in the Treatment of Atrial Fibrillation – a prospective, randomized controlled trial: Prehabilitation Study of the Cologne ExAfib Trial

High-Intensity Interval Training prior to Pulmonary Vein Ablation in the Treatment of Atrial Fibrillation – a prospective, randomized controlled trial: Prehabilitation Study of the Cologne ExAfib Trial - ExAfib-Prehab

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017836
Enrollment
60
Registered
2019-08-19
Start date
2019-08-20
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I48.0

Interventions

Group 1: High-intensity interval training on the stationary bike twice per week for 3 months, supervised by sports scientists and sports physicians. Group 2: Guideline-recommendation regarding physica

Sponsors

Deutsche Sporthochschule Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: - Male and female patients - between the ages of 40 and 80 years - symptomatic paroxysmal atrial fibrillation (EHRA = 2)

Exclusion criteria

Exclusion criteria: 80 years of age - significant limitation to the exercise of the intervention-arms - BMI = 35 - participation in regular aerobic or resistance exercise training in the last 6 months (> 60 minutes/week) - previous open heart surgery - left ventricular ejection fraction < 40% during sinus rhythm - significant valve disease - implanted cardiac pacemaker, ICD or resynchronization therapy - coronary artery disease without complete revascularization - unstable Angina - uncontrolled arrhythmias causing unstable conditions - uncontrolled hypertension - uncontrolled Diabetes mellitus - prior pulmonary vein ablation

Design outcomes

Primary

MeasureTime frame
Freedom from atrial fibrillation: time to ECG-documented recurrence Burden of atrial fibrillation: episodes documented during Holter-ECG and questionnaire Data collection T0 (pre exercise intervention) T1 (3 months after ablation) T2 (12 months after ablation).

Secondary

MeasureTime frame
Safety and Feasibility PVI-associated complications Physical fitness (VO2peak and strength) Muscle strength Subjective quality of life (SF-36) Major adverse cardiovascular events (MACE): Stroke, myocardial infarction, death from cardiovascular cause Minor adverse events Adherence rate AF-associated hospitalization Body composition inflammatory markers (CRP, Interleukins) Collagen turnover markers Cardiac function (echocardiography incl. strain analysis) Blood pressure (24h) Arterial stiffness (pulse wave analysis) Heart rate (24h: min, max, average) HRV (in sinus rhythm) Muscle hypertrophy (diameter of Vastus lateralis) Data collection T0 (pre exercise intervention) T1 (3 months after ablation) T2 (12 months after ablation).

Countries

Germany

Contacts

Public ContactJonas Zacher

Deutsche Sporthochschule Köln

j.zacher@dshs-koeln.de+49 221 4982 5270

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026