- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03659877
Identifying Physical Activity Intensity Through Accelerometry in Heart Failure
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Devon
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Exeter, Devon, United Kingdom, EX1 2LU
- University of Exeter
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient willing and able to give written informed consent to participate in study
- Adult (aged ≥18 years)
- Patients with confirmed diagnosis of heart failure
- Stable symptoms of heart failure
Exclusion Criteria:
- Patients with contraindications to exercise testing or physical activity
- Patients who are in a long term care establishment or who are unwilling or unable to travel to research site
- Patients who are unable to understand the study information.
- Patients judged to be unable to participate in the study for any other reason (e.g. diagnosis of dementia, psychiatric disorder, life-threatening comorbidity).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Heart failure patients
Patients will be required to perform a number of physical activity tasks such as laying down, sitting and walking.
During these activities, acceleration, oxygen consumption, rating of perceived exertion and heart rate will be recorded.
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Participants will undertake a variety of typical daily physical activities, such as laying down, sitting, walking whilst wearing accelerometers and gas analysis equipment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceleration
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).
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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.
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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).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen consumption (VO2)
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.
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Breath-by-breath gas analysis.
The average during the last minute of each activity the patient completes as per protocol is used.
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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.
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Carbon dioxide production (VCO2)
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.
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Breath-by-breath gas analysis.
The average during the last minute of each activity the patient completes as per protocol is used.
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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.
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Respiratory Exchange Ratio (RER)
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.
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Breath-by-breath gas analysis.
The average during the last minute of each activity the patient completes as per protocol is used.
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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.
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Rating of Perceived Exertion (RPE)
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
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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.
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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
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Heart Rate
Time Frame: Measured throughout study completion (up to three hours). It is collected during the last minute of each activity
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Heart rate measured via pulse oximeter
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Measured throughout study completion (up to three hours). It is collected during the last minute of each activity
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Grace Dibben, University of Exeter
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1617/036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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