Clinical trial NCT05592704: Remote Physical Activity Monitoring in Individuals With Metabolic Syndrome
Official title: The Development and Application of a Toolset for Monitoring Personalized Physical Activity and Evaluation of Its Effectiveness in Individuals With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome
Physical activity
Telemonitoring
Smartphone application
Wearables
Cardiovascular prevention
mHealth
Digital health
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Males (40-55 years) and females (50-65 years) with metabolic syndrome, having at least three of the following five criteria: hypertriglyceridemia (triglycerides ≥ 1.7 mmol/l); high-density lipoprotein cholesterol ≤ 1.03 mmol/l for men or ≤ 1.29 mmol/l for women; abdominal obesity (waist circumference \> 102 cm for men and \> 88 cm for women); elevated blood pressure (systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg or current use of antihypertensive drugs); elevated fasting plasma glucose ≥ 5.6 mmol/l;

Exclusion Criteria:

* Patients with overt cardiovascular disease (previous myocardial infarction, coronary artery bypass surgery, percutaneous coronary intervention, previous stroke)
* Patients with severe heart failure symptoms, uncontrolled hypertension
* Patients with urinary tract infection or fever for another unknown reason
* Patients who have actively exercised in the last 24 hours
* Pregnant women

Primary outcomes:
measure: Changes in carotid-radial pulse wave velocity and carotid-femoral pulse wave velocity
timeFrame: 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)
measure: Changes in mean blood pressure in the aorta, mean blood pressure in the brachial artery and pulse pressure in the aorta
timeFrame: 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)
measure: Changes in cardio-ankle vascular index
timeFrame: 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)
measure: Changes in common carotid artery intima-media thickness
timeFrame: 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)
measure: Changes in carotid artery ß stiffness index
timeFrame: 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)
measure: Changes in maximal oxygen consumption (VO2max)
timeFrame: 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)
measure: Changes in the levels of metabolic equivalents of task (METs)
timeFrame: 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)
measure: Changes in heart rate at rest and training heart rate
timeFrame: 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)
measure: Changes in lipids and glucose levels in the blood
timeFrame: 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)
measure: Changes in C-reactive protein levels in the blood
timeFrame: 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)
measure: Changes in body mass index (BMI)
timeFrame: 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)
measure: Changes in waist circumference
timeFrame: 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)
measure: Changes in blood pressure parameters
timeFrame: 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)
measure: Changes in the status of cardiovascular risk factors
timeFrame: 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)
measure: Changes in health-related quality of life
timeFrame: 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)
measure: Changes in motivation for physical activity
timeFrame: 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)
measure: Changes in the levels of anxiety and depression
timeFrame: 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)
measure: Changes in the levels of self-reported physical activity
timeFrame: 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)
Secondary outcomes:
measure: Changes in the levels of objectively measured physical activity
timeFrame: After 6 months (between 2nd and 3rd visit)
measure: Changes in the number of workouts
timeFrame: After 6 months (between 2nd and 3rd visit)
measure: Changes of compliance to the prescribed exercise in terms of workout duration
timeFrame: After 6 months (between 2nd and 3rd visit)
measure: Changes of compliance to the prescribed exercise in terms of intensity
timeFrame: After 6 months (between 2nd and 3rd visit)
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Outpatient clinic "InMedica"
Study officials:
affiliation: Clinic of Cardiac and Vascular Diseases, Faculty of Medicine, Vilnius University
name: Aleksandras Laucevicius, PhD
role: PRINCIPAL_INVESTIGATOR
References: