Evaluate changes in physical activity levels in the weeks following left ventricular assist device implantatio

Not Applicable

• Conditions: Chronic heart failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12614000233628
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Intervention group will have a confirmed history of NYHA functional class III/IV heart failure symptoms (where class III heart failure symptoms is characterised by shortness of breath during low level of activity and class IV heart failure symptoms is characterised by shortness of breath at rest), have been clinically stable on left ventricular assist device for at least 3 months and will be an outpatient. The control group will have NYHA functional class III/IV heart failure symptoms and will be taking routine heart failure management pharmaceutical therapy.

Exclusion Criteria

Participants with co-morbidities that may influence the ability to undertake physical activity (eg. severe renal, pulmonary or hepatic dysfunction, active uncontrolled systemic infection, several mitral or aortic valve insufficiency and severe musculoskeletal disease will be excluded from the study. Participants who receive a cardiac transplant during the physical assessment period will be withdrawn from the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the physical activity levels in stable participants on left ventricular assist device support, compared to chronic heart failure participants on optimal pharmaceutical management alone.<br><br>Actiheart is a small portable device that will be used during physical activity assessment. It measures heart rate, accelerometry or combination of both to calculate one’s body energy expenditure (BEE). However, we are relying on accelerometry function alone for this study. <br><br>The accelerometry data collected will be analysed using SPSS, version 21. If the data is normally distributed, unpaired t test will be used to compare the physical activity levels between LVAD and control group. The data not conforming to a normal distribution will be either transformed or analysed using non-parametric statistical test such as Mann-Whitney test. The level of statistical significance will be set at P<0.05.[After 7 days of assessment period]