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Trial registered on ANZCTR


Registration number
ACTRN12614000233628
Ethics application status
Approved
Date submitted
22/02/2014
Date registered
5/03/2014
Date last updated
5/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluate changes in physical activity levels in the weeks following left ventricular assist device implantation
Scientific title
The impact of left ventricular assist device implantation on physical activity levels in patients with chronic heart failure
Secondary ID [1] 284148 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic heart failure 291231 0
Condition category
Condition code
Cardiovascular 291577 291577 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Weeks
Description of intervention(s) / exposure
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.
Intervention code [1] 288840 0
Not applicable
Comparator / control treatment
Chronic heart failure participants with current NYHA functional class III/IV heart failure symptoms, but without LVADs will be allocated to the control group (as mentioned above). All participants in the control group will receive standard treatment where they will be taking routine heart failure management pharmaceutical therapy.

A subgroup of participants in the control group will also be provided with an additional physical activity monitor (Fitbit) that provides feedback to participants about their physical activity levels. The use of Fitbit will help to determine whether feedback about activity levels via mobile phone influences the amount of activity a person undertakes.
Control group
Active

Outcomes
Primary outcome [1] 291527 0
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.

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.

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.
Timepoint [1] 291527 0
After 7 days of assessment period
Secondary outcome [1] 306976 0
To assess the association between the physical activity levels, exercise self-efficacy, quality of life and aerobic capacity in participants on left ventricular assist device support and chronic heart failure participants on optimal pharmaceutical management alone.

The heart disease self-efficacy scale to be used in the proposed study describes one’s ability or confidence to begin, continue and complete a task under several specific circumstances. It consists of 16 statements, each describing a different physical act ranges from 0 to 100 (“0” describes an activity that a person “cannot do at all” and “100” is an activity a person rate as “absolutely certain I can do”).

SF-36 questionnaire is a generic instrument that is frequently used to measure one’s quality of life relating to a variety of health states. It consists of 36 questions, grouped into 8 health-related aspects of one’s life: physical function; social function; physical role; emotional role; mental health; energy; pain and general health perceptions. The score for each of the eight health concepts ranges from 0 (worst health status) to 100 (best health status).

Cardiopulmonary exercise testing is a non-invasive tool that measures the maximum amount of oxygen consumed by an individual. 12 ECG electrodes will be used to monitor heart rate and rhythm. Participants will be required to breath through a mouthpiece and asked to rate their perceived exertion and dyspnoea using Borg scale.

If the data is normally distributed, Pearson correlation will be used to determine the correlation between physical activity level with self-efficacy, quality of life and aerobic capacity in participants with LVADs support and CHF participants. The data not conforming to a normal distribution will be either transformed or analysed using non-parametric statistical test such as Spearman correlation. The level of statistical significance will be set at P<0.05.
Timepoint [1] 306976 0
After 7 days of assessment period

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/03/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2129 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 7814 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 288775 0
University
Name [1] 288775 0
Curtin University
Country [1] 288775 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
197 Wellington St, Perth CBD WA 6000
Country
Australia
Secondary sponsor category [1] 287473 0
University
Name [1] 287473 0
Curtin University
Address [1] 287473 0
Kent Street, Bentley WA 6102
Country [1] 287473 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290615 0
Royal Perth Hospital
Ethics committee address [1] 290615 0
197 Wellington St, Perth CBD WA 6000
Ethics committee country [1] 290615 0
Australia
Date submitted for ethics approval [1] 290615 0
13/08/2013
Approval date [1] 290615 0
26/09/2013
Ethics approval number [1] 290615 0
REG 13-122

Summary
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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46458 0
A/Prof Andrew Maiorana
Address 46458 0
Curtin University
GPO Box U1987 Perth WA 6845
Country 46458 0
Australia
Phone 46458 0
+618 92242681
Fax 46458 0
+618 92241464
Email 46458 0
[email protected]
Contact person for public queries
Name 46459 0
Andrew Maiorana
Address 46459 0
Curtin University
GPO Box U1987 Perth WA 6845
Country 46459 0
Australia
Phone 46459 0
+618 92242681
Fax 46459 0
+618 92241464
Email 46459 0
[email protected]
Contact person for scientific queries
Name 46460 0
Andrew Maiorana
Address 46460 0
Curtin University
GPO Box U1987 Perth WA 6845
Country 46460 0
Australia
Phone 46460 0
+618 92242681
Fax 46460 0
+618 92241464
Email 46460 0
[email protected]

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No Supporting Document Provided



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