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Completed

NCT Number: NCT05592704

Remote Physical Activity Monitoring in Individuals With Metabolic Syndrome

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.

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Key information

Conditions

Metabolic Syndrome Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic "InMedica"

Vilnius, LT-08406, Lithuania

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usage of a wearable heart rate monitor and a smartphone with the application for home-based exercises

Device

Physical activity self-monitoring using a wearable heart rate monitor and a smartphone with specially designed application

Primary outcomes

  1. Changes in carotid-radial pulse wave velocity and carotid-femoral pulse wave velocity

    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)

    Measured by applanation tonometry (SphygmoCor, ArtCor Medical, Sydney, Australia), all in m/s.

  2. Changes in mean blood pressure in the aorta, mean blood pressure in the brachial artery and pulse pressure in the aorta

    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)

    Measured by applanation tonometry (SphygmoCor, ArtCor Medical, Sydney, Australia), all in mmHg.

  3. Changes in cardio-ankle vascular index

    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)

    Measured by VaSera-1000 (Fukuda, Denshi, Japan).

  4. Changes in common carotid artery intima-media thickness

    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)

    Measured by performing a carotid artery ultrasound (in μm).

  5. Changes in carotid artery ß stiffness index

    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)

    Measured by performing a carotid artery ultrasound.

  6. Changes in maximal oxygen consumption (VO2max)

    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)

    Measured by performing a cardiopulmonary exercise test (Vmax® Encore 229, SensorMedics, USA) in ml/kg/min.

  7. Changes in the levels of metabolic equivalents of task (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)

    Measured by performing a cardiopulmonary exercise test (Vmax® Encore 229, SensorMedics, USA) in METs.

  8. Changes in heart rate at rest and training heart rate

    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)

    Measured by performing a cardiopulmonary exercise test (Vmax® Encore 229, SensorMedics, USA) in bpm.

  9. Changes in lipids and glucose levels in the blood

    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)

    Total cholesterol, triglycerides, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol levels and fasting glucose were measured in blood samples (all in mmol/L).

  10. Changes in C-reactive protein levels in the blood

    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)

    Measured in blood samples (in mg/L).

  11. Changes in body mass index (BMI)

    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)

    Weight (kg) and height (m) were measured to report BMI in kg/m^2.

  12. Changes in waist circumference

    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)

    Waist circumference was measured in cm.

  13. Changes in blood pressure parameters

    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)

    Systolic and diastolic blood pressure (in mmHg) were measured in a sitting position using oscillometric device.

  14. Changes in the status of cardiovascular risk factors

    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)

    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.

  15. Changes in health-related quality of life

    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)

    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).

  16. Changes in motivation for physical activity

    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)

    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.

  17. Changes in the levels of anxiety and 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)

    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.

  18. Changes in the levels of self-reported physical activity

    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)

    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.

Secondary outcomes

  1. Changes in the levels of objectively measured physical activity

    Time frame: After 6 months (between 2nd and 3rd visit)

    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.

  2. Changes in the number of workouts

    Time frame: After 6 months (between 2nd and 3rd visit)

    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.

  3. Changes of compliance to the prescribed exercise in terms of workout duration

    Time frame: After 6 months (between 2nd and 3rd visit)

    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.

  4. Changes of compliance to the prescribed exercise in terms of intensity

    Time frame: After 6 months (between 2nd and 3rd visit)

    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.

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Registry information

Official study title

The Development and Application of a Toolset for Monitoring Personalized Physical Activity and Evaluation of Its Effectiveness in Individuals With Metabolic Syndrome

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2022
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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