Trial document




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  DRKS00017836

Trial Description

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Title

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

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Trial Acronym

ExAfib-Prehab

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URL of the Trial

http://n.a.

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Brief Summary in Lay Language

The Ablation of the pulmonary veins is an established therapy for atrial fibrillation. We are studying, whether exercise in the weeks prior to the ablation will improve the results.

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Brief Summary in Scientific Language

The aim of the study is to analyze, whether a high-intensity-training-programme in the weeks before a pulmonary vein isolation by cryo-balloon will improve outcomes in patients with atrial fibrillation.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017836
  •   2019/08/19
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  •   yes
  •   Approved
  •   049/2019, Deutsche Sporthochschule Köln / German Sport university Cologne
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Secondary IDs

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Health Condition or Problem studied

  •   I48.0 -  Paroxysmal atrial fibrillation
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Interventions/Observational Groups

  •   High-intensity interval training on the stationary bike twice per week for 3 months, supervised by sports scientists and sports physicians.
  •   Guideline-recommendation regarding physical activity
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

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).

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Secondary Outcome

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).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • other 
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Recruitment

  •   Planned
  •   2019/08/20
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   80   Years
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Additional Inclusion Criteria

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

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Exclusion Criteria

< 40 or > 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

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Addresses

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    • Deutsche Sporthochschule Köln
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln
    • Mr.  Dr. med. Dipl. Sportwiss.  Jonas  Zacher 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln
    • Mr.  Dr. med. Dipl. Sportwiss.  Jonas  Zacher 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Sporthochschule Köln
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.