University of Exeter
Exeter, Devon, EX1 2LU, United Kingdom
NCT Number: NCT03659877
The primary objective of this study is to identify and evaluate the range of values provided by accelerometers during a variety of typical daily lifestyle activities for heart failure patients, and to relate these to the measured intensity of performing each activity in the heart failure population.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Exeter, Devon, EX1 2LU, United Kingdom
The precise measurement of physical activity is now possible with advances in wearable technology, namely accelerometers. This is useful in order to properly evaluate interventions such as cardiac rehabilitation that aim to increase physical activity. One of the challenges with accelerometry is the need for raw data to be translated into meaningful behavioural units. This is addressed through a calibration study, where accelerometry data is related to oxygen consumption and cut points are derived where activity is considered light, moderate or vigorous intensity. However, calibration studies have only been done in young and healthy adults, not in the elderly or those with chronic disease such as heart failure where movements are slower and exercise capacity is reduced. This means there is a risk of underestimating the true level of physical activity in this population. Therefore the aim of this study is to run a calibration study with 18-30 heart failure patients.
Adults (aged 18 years and older) diagnosed with heart failure, with stable symptoms that are willing and able to give informed consent will be eligible for the study. Patients with contraindications to physical activity will be excluded from the study. Patients will be identified from the Royal Devon & Exeter NHS Foundation Trust and the study will be conducted in the sports science laboratory at St Luke's Campus, University of Exeter. Each patient will be required to attend a single study visit that should last approximately 3 hours in total. During the visit patients will be required to complete a number of physical activity tasks (such as lying, sitting and walking) whilst wearing various accelerometers and gas analysis equipment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will undertake a variety of typical daily physical activities, such as laying down, sitting, walking whilst wearing accelerometers and gas analysis equipment.
Time frame: Accelerometers worn for up to three hours throughout the single patient visit. Accelerometers fitted after patient signs informed consent and worn until completion of the protocol (up to 3 hours).
acceleration (milli-g) values obtained via GENEActiv accelerometer (Activinsights, Kimbolton, UK) at multiple wear locations (both wrists, left thigh). Acceleration measured at 100Hz. Raw data reduced to one second epochs, then the average of these 1 second epochs calculated for each activity the patient completes.
Time frame: Gas analysis equipement is fitted after patient signs informed consent and worn until completion of the study protocol, up to three hours in one single patient visit.
Breath-by-breath gas analysis. The average during the last minute of each activity the patient completes as per protocol is used.
Time frame: Gas analysis equipement is fitted after patient signs informed consent and worn until completion of the study protocol, up to three hours in one single patient visit.
Breath-by-breath gas analysis. The average during the last minute of each activity the patient completes as per protocol is used.
Time frame: Gas analysis equipement is fitted after patient signs informed consent and worn until completion of the study protocol, up to three hours in one single patient visit.
Breath-by-breath gas analysis. The average during the last minute of each activity the patient completes as per protocol is used.
Time frame: This is collected throughout study completion (up to 3 hours). The patient is asked to give their RPE score during the last minute of each activity
Borg Rating of Perceived Exertion scale (minimum score 6- maximum score 20). This is a subjective measure of how hard the patient feels they are exerting themselves.
Time frame: Measured throughout study completion (up to three hours). It is collected during the last minute of each activity
Heart rate measured via pulse oximeter
University of Exeter
Other
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