Trial document




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  DRKS00016637

Trial Description

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Title

Different Exercise Interventions in the Treatment of Atrial Fibrillation – a prospective, randomized controlled trial.

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Trial Acronym

ExAfib

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients with paroxysmal atrial fibrillation will perform exercise to judge if it is safe and to analyse the effects of different exercise forms on the burden of the disease.

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Brief Summary in Scientific Language

Patients with paroxysmal AF will perform different forms of exercise (resistance, low-intensity endurance and high-intensitiy endurance) to investigate feasibility, effects on performance and various secondary outcomes.

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Organizational Data

  •   DRKS00016637
  •   2019/02/13
  •   [---]*
  •   yes
  •   Approved
  •   175/2018, Deutsche Sporthochschule Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I48 -  Atrial fibrillation and flutter
  •   I10 -  Essential (primary) hypertension
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Interventions/Observational Groups

  •   Control group: WHO recomendations, no additional training
  •   12 weeks resistance training 2x/week
  •   12 weeks classic low-intensity endurance training 2x/week
  •   12 weeks high intenisty training 2x/week
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment, Other
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

Feasibility (adherence / adverse events),
Physical fitness (VO2peak and strength)

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Secondary Outcome

- burden of atrial fibrillation, defined as time in atrial fibrillation, measured by Holter-ECG
- Muscle strength
- Subjective burden of AF
- 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)
- Kollagen 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 (viameter of Vastus lateralis)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2019/03/01
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

symptomatic paroxysmal atrial fibrillation (EHRA ≥ 2)

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Exclusion Criteria

- < 50 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
- previous open heart surgery
- left ventricular ejection fraction < 50% during sinus rhythm
- significant cardiac valve disease
- implanted cardiac pacemaker 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
- untreated secondary cause of AF (i.e. hyperthyroidism, etc.)
- former high-performance athlete
- < 4 episodes of AF / month
- any other contraindication or limitation to exercise

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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 KölnInstitut für Kreislaufforschung und Sportmedizin
    • Mr.  Dr. med. Dipl. Sportwiss.  Jonas  Zacher 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule KölnInstitut für Kreislaufforschung und Sportmedizin
    • 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.