Validation of a wrist-worn device for the assessment of energy expenditure in patients with chronic heart failure and coronary artery disease

Completed

• Conditions: chronic heart failure; congestive heart failure; 10019280

• Registration Number: NL-OMON45827
• Lead Sponsor: Maxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 38

Inclusion Criteria

Inclusion criteria heart failure patients:
- Minimum age 18 years
- Patients with heart failure with reduced ejection fraction (LVEF < 40%) due to ischemic or dilating cardiomyopathy
- New York Heart Association Class II to III
- Speaking Dutch language;Inclusion criteria patients with coronary artery disease:
- Minimum age of 18 years
- Stable coronary artery disease regardless of intervention (PCI or CABG)
- Speaking Dutch language

Exclusion Criteria

Exclusion criteria heart failure patients:
- Hemodynamically significant valvular disease
- Atrial fibrillation
- Peripheral vascular, neurological and orthopaedic conditions impairing exercise capacity
- Severe psychological or cognitive impairments;Exclusion criteria patients with coronary artery disease:
- Left ventricular ejection fraction < 50%
- Atrial fibrillation
- Peripheral vascular, neurological and orthopaedic conditions impairing exercise capacity
- Severe psychological or cognitive impairments

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the present study is to determine the accuracy of a<br /><br>wrist-worn activity tracker (Fitbit Charge 2) for the assessment of energy<br /><br>expenditure (kcal/min) during daily living activities in patients with stable<br /><br>coronary artery disease and chronic heart failure NYHA Class II-III, LVEF <<br /><br>40%.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective of the present study is to determine the accuracy of<br /><br>Fitbit Charge 2 in measuring energy expenditure (kcal/minute) in walking and<br /><br>cycling activities, in patients with stable coronary artery disease and heart<br /><br>failure NYHA Class II-III, LVEF < 40%.</p><br>