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Remote Physical Activity Monitoring in Individuals With Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Lithuania

Study Type

Interventional

Intervention

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

About this trial

This is an interventional other trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Physical activity, Telemonitoring, Smartphone application, Wearables, Cardiovascular prevention, mHealth, Digital health

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outpatient clinic "InMedica"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Individuals participated in the 2-month outpatient aerobic exercise training program, which consisted of 40 training sessions on a cycle ergometer 5 times/week for 40 min. Then during motivational consultation, individuals received recommendations for healthy lifestyle and home-based training. After that, study subjects participated in the 6-month home-based aerobic exercise program using wearable device (heart rate monitor), which was connected to the smartphone via Bluetooth. A special smartphone application enabled participants to keep their training heart rate during home-based exercises (or workouts).

Individuals participated in the 2-month outpatient aerobic exercise training program, which consisted of 40 training sessions on a cycle ergometer 5 times/week for 40 min. Then during motivational consultation, individuals received recommendations for healthy lifestyle and home-based training. After that, study subjects participated in the 6-month home-based aerobic exercise program without wearable devices and smartphone application.

Outcomes

Primary Outcome Measures

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.

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.

Changes in cardio-ankle vascular index

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

Changes in common carotid artery intima-media thickness

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

Changes in carotid artery ß stiffness index

Measured by performing a carotid artery ultrasound.

Changes in maximal oxygen consumption (VO2max)

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

Changes in the levels of metabolic equivalents of task (METs)

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

Changes in heart rate at rest and training heart rate

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

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).

Changes in C-reactive protein levels in the blood

Measured in blood samples (in mg/L).

Changes in body mass index (BMI)

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

Changes in waist circumference

Waist circumference was measured in cm.

Changes in blood pressure parameters

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

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.

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).

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.

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT05592704

First Posted

September 28, 2022

Last Updated

October 19, 2022

Sponsor

Vilnius University

1. Study Identification

Unique Protocol Identification Number

NCT05592704

Brief Title

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

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

August 21, 2017 (Actual)

Primary Completion Date

August 31, 2019 (Actual)

Study Completion Date

August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vilnius University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

Metabolic syndrome, Physical activity, Telemonitoring, Smartphone application, Wearables, Cardiovascular prevention, mHealth, Digital health

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Individuals participated in the 2-month outpatient aerobic exercise training program, which consisted of 40 training sessions on a cycle ergometer 5 times/week for 40 min. Then during motivational consultation, individuals received recommendations for healthy lifestyle and home-based training. After that, study subjects participated in the 6-month home-based aerobic exercise program without wearable devices and smartphone application.

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame