Remote Physical Activity Monitoring in Individuals With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05592704
• Other study ID #: PFAEV53
• Status: Completed
• Phase: N/A
• Start date: August 21, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: September 2022
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Device:
• Usage of a wearable heart rate monitor and a smartphone with the application for home-based exercises
Physical activity self-monitoring using a wearable heart rate monitor and a smartphone with specially designed application

Locations

Country	Name	City	State
Lithuania	Outpatient clinic "InMedica"	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)
Primary	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.	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)
Primary	Changes in cardio-ankle vascular index	Measured by VaSera-1000 (Fukuda, Denshi, Japan).	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)
Primary	Changes in common carotid artery intima-media thickness	Measured by performing a carotid artery ultrasound (in µm).	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)
Primary	Changes in carotid artery ß stiffness index	Measured by performing a carotid artery ultrasound.	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)
Primary	Changes in maximal oxygen consumption (VO2max)	Measured by performing a cardiopulmonary exercise test (Vmax® Encore 229, SensorMedics, USA) in ml/kg/min.	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)
Primary	Changes in the levels of metabolic equivalents of task (METs)	Measured by performing a cardiopulmonary exercise test (Vmax® Encore 229, SensorMedics, USA) in METs.	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)
Primary	Changes in heart rate at rest and training heart rate	Measured by performing a cardiopulmonary exercise test (Vmax® Encore 229, SensorMedics, USA) in bpm.	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)
Primary	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).	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)
Primary	Changes in C-reactive protein levels in the blood	Measured in blood samples (in mg/L).	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)
Primary	Changes in body mass index (BMI)	Weight (kg) and height (m) were measured to report BMI in kg/m^2.	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)
Primary	Changes in waist circumference	Waist circumference was measured in cm.	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)
Primary	Changes in blood pressure parameters	Systolic and diastolic blood pressure (in mmHg) were measured in a sitting position using oscillometric device.	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)
Primary	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.	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)
Primary	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).	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)
Primary	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.	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)
Primary	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.	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)
Primary	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.	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	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.	After 6 months (between 2nd and 3rd visit)
Secondary	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.	After 6 months (between 2nd and 3rd visit)
Secondary	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.	After 6 months (between 2nd and 3rd visit)
Secondary	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.	After 6 months (between 2nd and 3rd visit)