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

The impact of left ventricular assist device implantation on physical activity levels in patients with chronic heart failure

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12614000233628
Enrollment
30
Registered
2014-03-05
Start date
2014-03-10
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Left ventricular assist devices (LVAD) are pump that are implanted into the heart of patients with impaired heart function (heart failure) to assist in the pumping of blood around the body. An important objective of LVADs is to enable patients to achieve a more active lifestyle. Furthermore, physical activity and exercise are important components of the rehabilitation of patients with LVADs. The aim of this study is to compare the physical activity levels of stable patients with LVAD support (intervention group) compared with patients with advanced heart failure receiving optimal pharmaceutical management, but without LVAD support (control group).

Interventions

Stable participants with left ventricular assist devices (LVADs) support will be assigned to the intervention group and chronic heart failure participants with current NYHA functional class III/IV heart failure symptoms, but without LVADs will be allocated to the control group. All participants in both intervention and control groups will have to complete 2 questionnaires (heart disease self-efficacy scale & SF-36). They will then undergo an exercise test on a treadmill to measure their peak VO2

Stable participants with left ventricular assist devices (LVADs) support will be assigned to the intervention group and chronic heart failure participants with current NYHA functional class III/IV heart failure symptoms, but without LVADs will be allocated to the control group. All participants in both intervention and control groups will have to complete 2 questionnaires (heart disease self-efficacy scale & SF-36). They will then undergo an exercise test on a treadmill to measure their peak VO2. After the end of the assessment session, all participants will be given accelerometers (Actiheart) to measure their physical activity levels. Participants will be instructed to wear the Actiheart for 7 days and not to alter their usual physical activity during the assessment week. The assessment will be carried out individually at home. During the 7 days of assessment period, they will also receive follow up phone calls from the investigators.

Sponsors

Royal Perth Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026