Remote Physical Activity Monitoring in Individuals With Metabolic Syndrome

NCT ID: NCT05592704

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-21
• Study Completion Date: 2019-08-31

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).

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention group

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).

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksandras Laucevicius, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Outpatient clinic "InMedica"

Vilnius, , Lithuania

Countries

Lithuania

References

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.

Reference Type: DERIVED

PMID: 37625386 (View on PubMed)

Other Identifiers

PFAEV53

Identifier Type: -

Identifier Source: org_study_id