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Identifying Physical Activity Intensity Through Accelerometry in Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Physical activity
Sponsored by
University of Exeter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Physical Activity, Accelerometer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Exeter

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heart failure patients

Arm Description

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.

Outcomes

Primary Outcome Measures

Acceleration
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.

Secondary Outcome Measures

Oxygen consumption (VO2)
Breath-by-breath gas analysis. The average during the last minute of each activity the patient completes as per protocol is used.
Carbon dioxide production (VCO2)
Breath-by-breath gas analysis. The average during the last minute of each activity the patient completes as per protocol is used.
Respiratory Exchange Ratio (RER)
Breath-by-breath gas analysis. The average during the last minute of each activity the patient completes as per protocol is used.
Rating of Perceived Exertion (RPE)
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.
Heart Rate
Heart rate measured via pulse oximeter

Full Information

First Posted
October 25, 2017
Last Updated
October 29, 2018
Sponsor
University of Exeter
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1. Study Identification

Unique Protocol Identification Number
NCT03659877
Brief Title
Identifying Physical Activity Intensity Through Accelerometry in Heart Failure
Official Title
Identifying Physical Activity Intensity Through Accelerometry in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
October 23, 2018 (Actual)
Study Completion Date
October 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Exeter

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Physical Activity, Accelerometer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart failure patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
Participants will undertake a variety of typical daily physical activities, such as laying down, sitting, walking whilst wearing accelerometers and gas analysis equipment.
Primary Outcome Measure Information:
Title
Acceleration
Description
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
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).
Secondary Outcome Measure Information:
Title
Oxygen consumption (VO2)
Description
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.
Title
Carbon dioxide production (VCO2)
Description
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.
Title
Respiratory Exchange Ratio (RER)
Description
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.
Title
Rating of Perceived Exertion (RPE)
Description
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
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
Title
Heart Rate
Description
Heart rate measured via pulse oximeter
Time Frame
Measured throughout study completion (up to three hours). It is collected during the last minute of each activity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Dibben
Organizational Affiliation
University of Exeter
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Exeter
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX1 2LU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32817798
Citation
Dibben GO, Gandhi MM, Taylor RS, Dalal HM, Metcalf B, Doherty P, Tang LH, Kelson M, Hillsdon M. Physical activity assessment by accelerometry in people with heart failure. BMC Sports Sci Med Rehabil. 2020 Aug 12;12:47. doi: 10.1186/s13102-020-00196-7. eCollection 2020.
Results Reference
derived

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Identifying Physical Activity Intensity Through Accelerometry in Heart Failure

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