Identifying Physical Activity Intensity Through Accelerometry in Heart Failure

NCT ID: NCT03659877

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2018-10-23

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Exeter

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grace Dibben

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

University of Exeter

Exeter, Devon, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32817798 (View on PubMed)

Other Identifiers

1617/036

Identifier Type: -

Identifier Source: org_study_id