The primary objective of the present study is to determine the accuracy of the Philips health band for the assessment of total energy expenditure in recreational athletes, in patients with chronic heart failure and patients with coronary artery…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the agreement of energy expenditure in
kilocalories per minute, the heart rate and the respiratory rate assessed by
the Philips Health band and by continuous oxygen uptake assessment over the
entire protocol.
Secondary outcome
The agreement of heart and respiratory rate in beats and respirations per
minute throughout the entire protocol between Philips health band and Oxycon
mobile device.
Background summary
Cardiac rehabilitation (CR) has proven to reduce repeated cardiac events and
cardiovascular mortality. One of the most important goals of CR is improving
physical fitness and physical activity levels. Currently, exercise training
programmes are usually centre based, and evaluation or monitoring of physical
activity is not routinely applied. In order to monitor and promote physical
activity in cardiac patients successfully, reliable and non-obtrusive devices
to assess physical activity energy expenditure need to be available. The aim of
the present study is to validate the Philips Health band, a medically
certified, wrist-worn device, for the assessment of energy expenditure,
heartrate and respiratory rate, in patients with chronic heart failure,
coronary artery disease and recreational athletes.
Study objective
The primary objective of the present study is to determine the accuracy of the
Philips health band for the assessment of total energy expenditure in
recreational athletes, in patients with chronic heart failure and patients with
coronary artery disease during an activity protocol consisting of daily
activities, cycling and walking.
The secondary objective of the present study is to determine the accuracy of
the Philips health band for the assessment of heart and respiratory rate in
recreational athletes, in patients with chronic heart failure and patients with
coronary artery disease during an activity protocol consisting of daily
activities, cycling and walking.
Study design
This is a single centre validation study with a comparative design. Energy
expenditure, heart rate and respiratory rate assessed by the Philips health
band will be compared to energy expenditure calculated from oxygen uptake
measurement by the oxycon mobile during an exercise protocol containing low-to
moderate-intensity activities representative for daily physical activity. The
oxycon mobile is a wireless portable cardiopulmonary stress testing device. The
device measures breath-by-breath VO2 and VCO2. Using the Weir equation energy
expenditure can be calculated. Heart frequency will be measured with a 12-leads
ECG that is connected to the oxycon mobile.
Study burden and risks
Although there is no direct benefit for individual patients participating in
this study, the results of this study will be used to improve future cardiac
telerehabilitation strategies by implementing accurate assessment of daily
activity levels. As the activities involved are in the
low-to-moderate-intensity domain and are similar to daily activities, the risk
of adverse events in these clinically stable patient categories is considered
very low. The investigational product (Philips Health band) and the reference
measurement method (Mobile oxycon) are both light weighted and easy to wear as
they are developed for measurements during exercise and daily activities.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79217.015.21 |