Actively Recruiting
Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors After Cardiac Rehabilitation - A Randomised Controlled Trial: MITIGATE-RF
Led by University Hospital, Basel, Switzerland · Updated on 2024-08-14
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how wearing smart watches and continuous glucose monitoring devices affects cardiovascular risk factors in patients with coronary heart disease who have completed cardiac rehabilitation. The study will recruit 100 patients, randomly assigning them to either an intervention group or a control group for three months. Researchers will look at changes in factors like blood pressure, cholesterol (LDL), blood sugar control (HbA1c), body mass index (BMI), physical activity, nutrition, and smoking habits. Participants in the intervention group will receive a Fitbit Inspire 2 smart watch and an Abbott Freestyle Libre 3 continuous glucose monitor, which they will wear for three months. The control group will receive standard care recommendations typical for patients finishing cardiac rehabilitation. Randomization will consider age, sex, BMI, diabetes status, blood pressure, and time since rehabilitation completion. Data on sleep, temperature, heart rate, breathing rate, activity, oxygen levels, and weight will be collected through the Fitbit app. During the study, all participants will complete questionnaires and have physical measurements taken at the start and end of the study. Blood samples will also be collected at these times. The researchers will monitor cardiovascular risk scores using multiple measurements over the three months. The total participation time is about four months, including recruitment and study duration. The study is sponsored by University Hospital, Basel, Switzerland, and aims to better understand how wearable technology might influence heart health after rehabilitation.
CONDITIONS
Brief Title
Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Completed outpatient cardiac rehabilitation
- Diagnosis of coronary heart disease
- Access to a smartphone for the duration of the study
- 18 years or older on the date of consent
You will not qualify if you...
- Diseases limiting physical activity such as angina with incomplete revascularisation, arrhythmogenic cardiomyopathy, stroke with residual disease, or major orthopaedic disorders
- Known or suspected non-compliance
- Inability to follow study procedures due to language, psychological, or cognitive issues
- Diabetic patients receiving insulin therapy
- Lack of proficiency with smartphone or watch
- Current participation in another clinical trial that may affect results
- NYHA class III or IV congestive heart failure
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants in the intervention arm will wear a smartwatch and a continuous glucose measuring device for 3 months to monitor physical activity and glucose levels.
Participants will have baseline and end-of-study visits for measurements and questionnaires; continuous data collection via devices occurs throughout the period.
Duration - Baseline and after 3 months
Participants complete questionnaires and anthropomorphic measurements, and provide blood samples at baseline and after 3 months to assess cardiovascular risk factors.
2 visits (baseline and end-of-study, in-person)
Trial Site Locations
Total: 1 location
1
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
J
Jan Gerrit van der Stouwe, Dr. med.
P
Patrick Badertscher, Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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