Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000242820
Ethics application status
Approved
Date submitted
26/10/2009
Date registered
24/02/2012
Date last updated
24/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising functional capacity in patients with ventricular dysfunction:
A focus on enhancing skeletal muscle mechanics
Scientific title
The effect of an eccentric exercise training program versus conventional resistance exercise training of the lower limb muscles on functional capacity in patients with ventricular dysfunction: A focus on enhancing skeletal muscle mechanics
Secondary ID [1] 280026 0
Exercise and biomechanics in heart failure
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure 252051 0
Condition category
Condition code
Cardiovascular 252245 252245 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to determine the best type of exercise for people with heart conditions.

This intervention will include either Eccentric Exercise Training of the lower limb muscles, Conventional Resistance Exercise Training of the lower limb muscles, or no training (control group). Participants will be randomly assigned into one of these three groups.

The exercise programs will consist of 30 minutes of exercise 3 days per week for a period of 12 weeks and will be conducted in small classes of participants. The exercise will consist of localized calf muscle exercises and will be supervised by a trained exercise physiologist.

The Conventional Resistance Exercise training is similar to standard concentric calf raises. The the participant is asked to push against a footplate in a manner to move the plate away from the foot (similar to pressing a gas pedal). In this exercise the muscles shorten as they are active.

The Eccentric Exercise Training involves resisting the footplate as it forces the ankle to dorsifles (opposite direction of movement to the Conventional Resistance Exercise). In this exercise the muscles lengthened as they are active.
Intervention code [1] 241449 0
Rehabilitation
Comparator / control treatment
Non-Training Group
Control group
Active

Outcomes
Primary outcome [1] 253119 0
Exercise Capacity (Peak rate of oxygen consumption; VO2)

We will assess peak VO2 using a modified chronotropic assessment protocol in which stages are incremented by set and regular workloads. Heart rate and rhythm and
oxygen saturation will be measured continuously by 12-lead Electrocardiogram (ECG) and pulse oximeter respectively.
Blood pressure, rating of perceived exertion (Borg Scale) and perceived dyspnoea (Borg Scale) will
be recorded during the final 30 seconds of each level. Indirect calorimetry will be measured employing a Vmax metabolic cart to establish VO2peak.
Timepoint [1] 253119 0
at baseline and at 6 and 12 weeks after intervention commencement
Secondary outcome [1] 257990 0
Muscle Mechanical Work Capacity. This outcome measure will be measured on an isokinetic dynamometer (Biodex), whereby the participant will push as hard as possible (e.g. one repetition maximum) against an instrumented footplate throughout the ankle range of motion. Recordings from the footplate will measure the torque and displacement of the ankle and will be used to calculate total mechanical work. These measurements will be repeated 3-4 times with a minimum of two minutes rest between contractions.
Timepoint [1] 257990 0
at baseline and at 6 and 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
Chronic Heart Failure
New York Heart Association (NYHA) class II-IV
ejection fraction <50%
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable angina or exercise-induced Ischaemia at low exercise levels
Severe aortic stenosis
Severe mitral or aortic regurgitation
Hypertrophic cardiomyopathy
treated hypertension >160/100mmHg at rest)
Hypercholesterolaemia (total cholesterol >7.0 mmolL-1)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243922 0
University
Name [1] 243922 0
The University of Western Australia
Country [1] 243922 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Hwy
Crawley, WA, 6009
Country
Australia
Secondary sponsor category [1] 251282 0
None
Name [1] 251282 0
Address [1] 251282 0
Country [1] 251282 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244036 0
Human Research Ethics Committee, The University of Western Australia
Ethics committee address [1] 244036 0
Research Ethics
Research Services
The University of Western Australia

35 Stirling Hwy
Crawley, WA, 6009
Australia
Ethics committee country [1] 244036 0
Australia
Date submitted for ethics approval [1] 244036 0
28/08/2009
Approval date [1] 244036 0
25/11/2009
Ethics approval number [1] 244036 0
RA/4/1/2533
Ethics committee name [2] 286773 0
Royal Perth Hospital Ethics Commitee
Ethics committee address [2] 286773 0
Ethics Office
Room 5105 Level 5, Colonial House
Royal Perth Hospital
Perth, WA, 6000
Ethics committee country [2] 286773 0
Australia
Date submitted for ethics approval [2] 286773 0
29/11/2010
Approval date [2] 286773 0
21/02/2011
Ethics approval number [2] 286773 0
EC 2011/019

Summary
Brief summary
Chronic heart failure (CHF) is a major health burden in Australia, with an estimated 300,000 patients affected. Our goal is to optimise approaches aimed at enhancing exercise capacity in these patients, which will directly translate to improved prognosis and morbidity in advanced CHF.
Our aims will be achieved by bringing together novel biomechanical and physiological approaches that have not previously been applied in the context of CHF in testing the following hypotheses:
1) The mechanical work capacity of skeletal muscle will be significantly lower in CHF patients, compared to age-matched controls. This will be linked to sub-optimal in vivo mechanical properties of the muscle.
2) Eccentric exercise training (EET) will significantly increase a) the mechanical work capacity of the skeletal muscle and b) exercise capacity in CHF, relative to the impact of conventional exercise training approaches.

Significance: Exercise intolerance is a cardinal symptom of CHF and is associated with poor prognosis.The locus of physical limitations in CHF is typically in the periphery (skeletal muscle). However, traditional approaches to exercise rehabilitation in CHF have borrowed from ideas that work in healthy populations, in whom the limitations to performance differ from those relevant to CHF. Surprisingly, no studies have investigated the relevance of in vivo skeletal muscle mechanical characteristics in these patients. Consequently, no exercise interventions have been applied which are specifically designed to ameliorate skeletal muscle biomechanical limitations in CHF. We propose that eccentric training will significantly improve skeletal muscle mechanics and exercise capacity, compared to conventional exercise approaches. The findings from this study will help to optimise exercise prescription in CHF, directly benefiting CHF life expectancy and quality, and will encourage the widespread prescription of evidence-based exercise approaches for patients with CHF.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30413 0
Address 30413 0
Country 30413 0
Phone 30413 0
Fax 30413 0
Email 30413 0
Contact person for public queries
Name 13660 0
Prof. Daniel Green
Address 13660 0
School of Sport Science, Exercise and Health
The University of Western Australia, M408
35 Stirling Hwy
Crawley, WA, Australia
6009
Country 13660 0
Australia
Phone 13660 0
+61 8 6488 5609
Fax 13660 0
+61 8 6488 1039
Email 13660 0
[email protected]
Contact person for scientific queries
Name 4588 0
Prof. Daniel Green
Address 4588 0
School of Sport Science, Exercise and Health
The University of Western Australia, M408
35 Stirling Hwy
Crawley, WA, Australia
6009
Country 4588 0
Australia
Phone 4588 0
+61 8 6488 5609
Fax 4588 0
+61 8 6488 1039
Email 4588 0
[email protected]

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