A prospective intervention study to evaluate the effectiveness of the developed toolset for remote physical activity monitoring to improve arterial stiffness and other cardiometabolic parameters and to increase physical activity levels and the compliance to the prescribed exercise in individuals with metabolic syndrome.
At first, all subjects of the prospective study participated in the 2-month outpatient aerobic exercise program, which consisted of 40 aerobic training sessions on a cycle ergometer 5 times/week for 40 min. During all training sessions, heart rate was maintained at the targeted level, which was obtained individually by cardiopulmonary test. After 2 months, during individual motivational consultations, all participants received recommendations for home-based training and were randomly allocated to the intervention or the control group. Then only the intervention group subjects participated in the 6-month home-based aerobic exercise program using a wearable heart rate monitor, which was connected to the smartphone via Bluetooth. The intervention group subjects used a smartphone application created for the study. The control group participants were asked to exercise at home for 6 months without wearables and smartphone application. The evaluation of the study participants was performed at baseline (1st visit), after 2 months (2nd visit) and after 8 months (3rd visit).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
200
Physical activity self-monitoring using a wearable heart rate monitor and a smartphone with specially designed application
Outpatient clinic "InMedica"
Vilnius, Lithuania
Changes in carotid-radial pulse wave velocity and carotid-femoral pulse wave velocity
Measured by applanation tonometry (SphygmoCor, ArtCor Medical, Sydney, Australia), all in m/s.
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in mean blood pressure in the aorta, mean blood pressure in the brachial artery and pulse pressure in the aorta
Measured by applanation tonometry (SphygmoCor, ArtCor Medical, Sydney, Australia), all in mmHg.
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in cardio-ankle vascular index
Measured by VaSera-1000 (Fukuda, Denshi, Japan).
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in common carotid artery intima-media thickness
Measured by performing a carotid artery ultrasound (in μm).
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in carotid artery ß stiffness index
Measured by performing a carotid artery ultrasound.
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in maximal oxygen consumption (VO2max)
Measured by performing a cardiopulmonary exercise test (Vmax® Encore 229, SensorMedics, USA) in ml/kg/min.
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
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Changes in the levels of metabolic equivalents of task (METs)
Measured by performing a cardiopulmonary exercise test (Vmax® Encore 229, SensorMedics, USA) in METs.
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in heart rate at rest and training heart rate
Measured by performing a cardiopulmonary exercise test (Vmax® Encore 229, SensorMedics, USA) in bpm.
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in lipids and glucose levels in the blood
Total cholesterol, triglycerides, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol levels and fasting glucose were measured in blood samples (all in mmol/L).
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in C-reactive protein levels in the blood
Measured in blood samples (in mg/L).
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in body mass index (BMI)
Weight (kg) and height (m) were measured to report BMI in kg/m\^2.
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in waist circumference
Waist circumference was measured in cm.
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in blood pressure parameters
Systolic and diastolic blood pressure (in mmHg) were measured in a sitting position using oscillometric device.
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in the status of cardiovascular risk factors
Smoking status (smoking \< 10 cigarettes/day (yes/no), smoking \> 10 cigarettes/day (yes/no), non-smoking (yes/no), smoking cessation (yes/no)), arterial hypertension status (yes/no), dyslipidaemia status (yes/no) were assessed in medical records.
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in health-related quality of life
Health-related quality of life was evaluated by the Medical Outcomes Study 36-Item Short-Form Health Survey. In this questionnaire, each domain of health-related quality of life is scored from 0 to 100 (100 points show the best estimate).
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in motivation for physical activity
The motivation for physical activity was evaluated by the Exercise Motivations Inventory-2 (EMI-2). In this questionnaire, the answer to each statement is given on a six-step scale from 0 points ("not at all true for me") to 5 points ("very true for me"). Higher mean scores in the appropriate items of the 14 subscales indicate better result.
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in the levels of anxiety and depression
The levels of anxiety and depression were evaluated by the Hospital Anxiety and Depression scale, where 8-10 scores indicate mild, 11-14 scores - moderate, and 15-21 scores - severe anxiety or depression.
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in the levels of self-reported physical activity
The levels of self-reported physical activity (in minutes/week) were measured by using the International Physical Activity Questionnaire short form (IPAQ-sf). Higher values indicate better result.
Time frame: After 2 months (between 1st and 2nd visit), after 6 months (between 2nd and 3rd visit), after 8 months (between 1st visit and 3rd visit)
Changes in the levels of objectively measured physical activity
Total duration of physical activity (in minutes) and duration of physical activity divided by the type and timing of workout (in minutes) were measured by the real-time physical activity data received through the smartphone application.
Time frame: After 6 months (between 2nd and 3rd visit)
Changes in the number of workouts
Total number of workouts and number of workouts divided by the type and timing of workout were measured by the real-time physical activity data received through the smartphone application.
Time frame: After 6 months (between 2nd and 3rd visit)
Changes of compliance to the prescribed exercise in terms of workout duration
The average workout duration (in minutes) was measured by the real-time physical activity data received through the smartphone application. Higher values indicate better compliance.
Time frame: After 6 months (between 2nd and 3rd visit)
Changes of compliance to the prescribed exercise in terms of intensity
The proportion (%) of the workout time in prescribed exercise intensity was measured by the real-time physical activity data received through the smartphone application. Higher values indicate better compliance.
Time frame: After 6 months (between 2nd and 3rd visit)