Identifying Physical Activity Intensity Through Accelerometry in Heart Failure

Sponsor
University of Exeter (Other)
Overall Status
Completed
CT.gov ID
NCT03659877
Collaborator
(none)
22
1
1
6.7
3.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Physical activity
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Identifying Physical Activity Intensity Through Accelerometry in Heart Failure
Actual Study Start Date :
Apr 3, 2018
Actual Primary Completion Date :
Oct 23, 2018
Actual Study Completion Date :
Oct 23, 2018

Arms and Interventions

Arm Intervention/Treatment
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.

Behavioral: Physical activity
Participants will undertake a variety of typical daily physical activities, such as laying down, sitting, walking whilst wearing accelerometers and gas analysis equipment.

Outcome Measures

Primary Outcome Measures

  1. Acceleration [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.

Secondary Outcome Measures

  1. Oxygen consumption (VO2) [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.

  2. Carbon dioxide production (VCO2) [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.

  3. Respiratory Exchange Ratio (RER) [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.

  4. Rating of Perceived Exertion (RPE) [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.

  5. Heart Rate [Measured throughout study completion (up to three hours). It is collected during the last minute of each activity]

    Heart rate measured via pulse oximeter

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Exeter Exeter Devon United Kingdom EX1 2LU

Sponsors and Collaborators

  • University of Exeter

Investigators

  • Principal Investigator: Grace Dibben, University of Exeter

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Exeter
ClinicalTrials.gov Identifier:
NCT03659877
Other Study ID Numbers:
  • 1617/036
First Posted:
Sep 6, 2018
Last Update Posted:
Oct 30, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Exeter
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 30, 2018