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Validation of the Philips Health band, a wrist-worn device for the assessment of energy expenditure, heart and respiratory rate in patients with chronic heart failure, coronary artery disease and recreational athletes

Completed
Conditions
Chronic heart failure
congestive heart failure
10019280
Registration Number
NL-OMON50668
Lead Sponsor
Maxima Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
57
Inclusion Criteria

Inclusion criteria chronic heart failure patients:
- Minimum age 18 years
- Patients with symptomatic chronic heart failure with reduced or mildly
reduced ejection fraction (NYHA Class II-III, LVEF < 50%) 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

Inclusion criteria recreational athletes:
- Minimum age of 35 years
- Perform at least 30 weeks of sports a year. With a minimum of 2,5 hours of
the same sports or 1,5 hours of different sports a week.
- Have had at least one consultation at the sports cardiologist
- 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
- Severe pulmonary conditions impairing exercise capacity
- Skin conditions or wounds around the wrist area

Exclusion criteria patients with coronary artery disease:
- Left ventricular ejection fraction <50%
- Hemodynamically significant valvular disease
- Atrial fibrillation
- Peripheral vascular, neurological and orthopaedic conditions impairing
exercise
capacity
- Severe psychological and cognitive impairments
- Severe pulmonary conditions impairing exercise capacity
- Skin conditions or wounds around the wrist area

Exclusion criteria recreational athletes:
- Left ventricular ejection fraction <50%
- Hemodynamically significant valvular disease
- Symptomatic coronary artery disease
- Atrial fibrillation
- Peripheral vascular, neurological and orthopaedic conditions impairing
exercise capacity
- Severe psychological and cognitive impairments
- Severe pulmonary conditions impairing exercise capacity
- Skin conditions or wounds around the wrist area

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study parameters are the agreement of energy expenditure in<br /><br>kilocalories per minute, the heart rate and the respiratory rate assessed by<br /><br>the Philips Health band and by continuous oxygen uptake assessment over the<br /><br>entire protocol. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The agreement of heart and respiratory rate in beats and respirations per<br /><br>minute throughout the entire protocol between Philips health band and Oxycon<br /><br>mobile device. </p><br>
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