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

Phase 2

Recruiting

• Conditions: I48; I10; Atrial fibrillation and flutter; Essential (primary) hypertension

• Registration Number: DRKS00016637
• Lead Sponsor: Deutsche Sporthochschule Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

symptomatic paroxysmal atrial fibrillation (EHRA = 2)

Exclusion Criteria

- < 60 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
- left ventricular ejection fraction < 40% 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
- any other contraindication or limitation to exercise

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and feasibility (adherence / adverse events)

Secondary Outcome Measures

Name	Time	Method
- Physical fitness (VO2peak and strength)<br>- burden of atrial fibrillation, defined as time in atrial fibrillation, measured by Holter-ECG<br>- Muscle strength<br>- Subjective burden of AF<br>- Subjective quality of life (SF-36)<br>- Major adverse cardiovascular events (MACE): Stroke, myocardial infarction, death from cardiovascular cause<br>- Minor adverse events<br>- Body composition<br>- inflammatory markers (CRP, Interleukins)<br>- Cardiac function (echocardiography incl. strain analysis; NTproBNP)<br>- Blood pressure (24h)<br>- Arterial stiffness (pulse wave analysis)<br>- Heart rate (24h: min, max, average)<br>- HRV (in sinus rhythm)<br>- Muscle hypertrophy (viameter of Vastus lateralis)