Remote Physical Activity Monitoring in Individuals With Metabolic Syndrome

NCT05592704 | Completed

• 1 other identifier: PFAEV53
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (18)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (4)

• Changes in the levels of objectively measured physical activity

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

• Changes in the number of workouts

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

• Changes of compliance to the prescribed exercise in terms of workout duration

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

• Changes of compliance to the prescribed exercise in terms of intensity

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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).

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

Control group

NO INTERVENTION

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.

Interventions

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

Intervention group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (1)

Outpatient clinic "InMedica"

Vilnius, LT-08406, Lithuania

Location

Related Publications (1)

• Zupkauskiene J, Lauceviciene I, Ryliskyte L, Navickas P, Kizlaitis R, Laucevicius A. Ambulatory and successive home-based heart rate targeted aerobic training improves arterial parameters: a follow-up study in people with metabolic syndrome. Ann Med. 2023;55(2):2250363. doi: 10.1080/07853890.2023.2250363.

  PMID: 37625386 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Aleksandras Laucevicius, PhD

  Clinic of Cardiac and Vascular Diseases, Faculty of Medicine, Vilnius University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 25, 2022
• Study Start: August 21, 2017
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: October 25, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)