Exercise Effects on Atrial Fibrillation

Primary outcomes

1. Concentration of proteins in blood (proteome).

   Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

   Venous blood samples are collected from the antecubital vein and kept at 4°C until preparation to avoid clotting and minimise protein degradation. Samples are centrifuged at 1500 g for 10 minutes at 4°C.

   Samples shall are stored at -80°C for subsequent analysis and only one freeze-thaw cycle shall be allowed. All samples shall are prepared within 1 hour of sample collection and show no signs of haemolysis.

   The protein concentrarion will be analyzed (μg/ml).

2. Oxidative stress status

   Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

   Oxidative stress is measured through the analysis of plasma oxidative stress biomarkers concentrations in pg/ml.

3. Cardiac function: concentrations (pg/ml) of NT-proBNP (type B natriuretic peptide).

   Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

   Measurement of cardiac dysfunction is analyzed through the presence of plasma markers of cardiac injury (NT-proBNP; pg/ml).

4. Maximal strength of upper and lower extremity muscles.

   Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

   Maximal strength of upper and lower extremity muscles from one concentric repetition maximum (1RM) of half squat and bench press will be assessed (maximal strength).

   Measurements in weight lifted and the number of times. Maximum Repetition or 1RM is the maximum weight (kg) you can move in just one time.

5. Functional variables: power strength by bar displacement

   Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

   Changes in bar displacement in centimeter (cm).

6. Functional variables: power strength by propulsive velocity

   Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

   Mean propulsive velocity (in meter per second).

7. Functional variables: power strength

   Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

   Average power (in watts).

8. Functional variables: Handgrip strength.

   Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

   Changes in the manual dynamometer measurements (in kg).

9. Functional variables: Assessment of cardiorespiratory capacity.

   Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

   Changes in measurements by a treadmill. The following variables will be assessed before and after the cardiorespiratory capacity measurement:

   • Gas exchange analysis (VO2, VCO2), in ml·kg-1·min-1.
   • Maximum speed in treadmill (km/h).
   • Blood pressure (systolic pressure and diastolic pressure in mm Hg).
   • Heart rate (bpm).
   • Rate of perceived exertion (RPE) using a RPE-CR10 scale.

10. Functional variables: Assessment of functional capacity (6MWT).

    Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

    Changes in six-minute walk test (6MWT): number of laps around the hallway and the additional distance covered on the last lap if it is not completed using the markings in the hallway. The outcome measure is quantified in meters.

11. Functional variables: Levels of physical activity

    Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

    GT3X+ accelerometers estimate physical activity levels based on the accelerometer output in units called "counts per minute".

12. Clinical variables: Short Form-36 Health Survey (SF-36).

    Time frame: 0 weeks, 13 weeks, 24 weeks.

    The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). A final item, termed self-reported health transition, is answered by the client but is not included in the scoring process. The SF-36 offers a choice of recall format at a standard (4 week) or acute (1 week) time frame. Likert scales and yes/no options are used to assess function and well-being on this 36-item questionnaire. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value.

13. Clinical variables: Atrial fibrillation burden.

    Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

    Changes in electrocardiogram (electrical signal from the heart to detect different heart conditions).

14. Clinical variables: Atrial fibrillation burden (subjective measurement).

    Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

    Changes in Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire: palpitations, dyspnea, fatigue and limitations in daily activities. AFEQT evaluates health-related quality of life (HRQoL) and provides an overall score; plus scores for symptoms, daily activities, treatment concerns, and treatment satisfaction.

    20 questions on 7-point Likert scale Overall or subscale scores range from 0-100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).

15. Clinical variables: Arterial stiffness.

    Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

    Changes in the images of the right common carotid artery are obtained using an ultrasound.

16. Clinical variables: Heart rate variability.

    Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

    Changes in the variation in the time intervals between heartbeats (R-R intervals).

17. Clinical variables: Vascular dysfunction.

    Time frame: 0 weeks, 2 weeks, 13 weeks, 24 weeks.

    The cardio-ankle vascular index (CAVI) is a new index of the overall stiffness of the artery from the origin of the aorta to the ankle. CAVI values range from 3 to 18. Depending on the cut-off values.

    Standardized values established by the manufacturer, a value < 8 is considered normal, between 8 and 9 is borderline, and 9 is high and indicates advanced atherosclerosis.