NCT03659877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

April 3, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2018

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

October 25, 2017

Last Update Submit

October 29, 2018

Conditions

Heart Failure

Keywords

Physical ActivityAccelerometer

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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

  • Heart Rate

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

Study Arms (1)

Heart failure patients

EXPERIMENTAL

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

Interventions

Physical activityBEHAVIORAL

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

Heart failure patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 32817798DERIVED

MeSH Terms

Conditions

Heart FailureMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Grace Dibben

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

September 6, 2018

Study Start

April 3, 2018

Primary Completion

October 23, 2018

Study Completion

October 23, 2018

Last Updated

October 30, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)