Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000820909
Ethics application status
Approved
Date submitted
23/06/2020
Date registered
17/08/2020
Date last updated
17/08/2020
Date data sharing statement initially provided
17/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the influence of leg and respiratory muscle function in heart failure
Scientific title
Identifying the impact of peripheral and respiratory muscle training on metaboreflex and cardiac outcomes in heart failure
Secondary ID [1] 300446 0
None
Universal Trial Number (UTN)
U1111-1247-7252
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 316111 0
Condition category
Condition code
Cardiovascular 314398 314398 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions being assessed are different types of exercise training or control for eight weeks for participants with heart failure:
Arm 1: Peripheral muscle training (such as cycle ergometry for leg training)
Arm 2: Respiratory muscle training (using a threshold loading device for inspiratory muscle training, such as a POWERbreathe device)
Arm 3: Peripheral and respiratory muscle training
Arm 4: No training
Arm 5: healthy controls (no training, assessed pre and post)
Patients in the respiratory muscle training and respiratory muscle+peripheral training groups will perform respiratory muscle training for 30 min, 5 times per week, for 8 weeks using a threshold-loading device (POWERbreathe, HaB International Ltd., Southam, UK) set at a workload equal to 60% of their maximal inspiratory pressure (MIP). Participants will breathe through the PowerBreathe device with a normal breathing frequency (not paced breathing) during these sessions. MIP will be assessed at the beginning of each training week, in order to optimise the training workload commensurate with any gains in respiratory muscle strength. Each week, 4 training sessions will be performed at home and 1 training session will be performed in the laboratory under supervision of a physiotherapist or exercise physiologist to ensure compliance with the training protocol. Participant compliance to home-based training will be monitored with home exercise diaries.
The peripheral and respiratory muscle training+ peripheral muscle groups will attend the laboratory 3 times per week for the leg muscle training. At each visit, subjects will perform 30 min of constant load exercise, intermittently (5 min exercise, 1 min active recovery) on a cycle ergometer with the workload set to 65–75% of the maximal work determined via the exercise test conducted at baseline.
Intervention code [1] 316738 0
Treatment: Other
Intervention code [2] 316739 0
Rehabilitation
Intervention code [3] 318113 0
Treatment: Devices
Comparator / control treatment
The 3 exercise arms will be compared to two non-exercising groups, one with heart failure (main comparator) and one with healthy, matched control participants.
Control group
Active

Outcomes
Primary outcome [1] 322750 0
Echocardiography, using a Vivid E9™ ultrasound scanner (GE Vingmed Ultrasound AS, Horten, Norway) with a transthoracic matrix phased-array transducer (4V-D, GE Vingmed Ultrasound AS) will be used to assess global longitudinal strain.
Timepoint [1] 322750 0
Baseline and 8 weeks after intervention commencement
Primary outcome [2] 322751 0
Changes in the respiratory muscle metaboreflex response. This will be assessed using the composite of changes in beat to beat blood pressure, heart rate (Finapres Nova, Finapres Medical Systems, The Netherlands) and inactive limb blood flow (duplex Doppler ultrasound ,Terason T3200, Burlington, MA, USA). The reflex will be elicited by using an inspiratory threshold-loading protocol, (POWERbreathe HaB International Ltd., Southam, UK).
Timepoint [2] 322751 0
Baseline and 8 weeks after intervention commencement
Primary outcome [3] 322752 0
Changes in the peripheral muscle metaboreflex response. This will be assessed using the composite of changes in beat to beat blood pressure, heart rate (Finapres Nova, Finapres Medical Systems, The Netherlands) and inactive limb blood flow (duplex Doppler ultrasound ,Terason T3200, Burlington, MA, USA). The reflex will be elicited by exercising the limb, then occluding blood flow with a rapid cuff inflation to a suprasystolic pressure (Hokanson E20, Bellevue, WA, USA) for 3 minutes.
Timepoint [3] 322752 0
Baseline and 8 weeks after intervention commencement
Secondary outcome [1] 379569 0
Near infrared spectroscopy (NIRS) assessment of muscle oxidative capacity. Recovery kinetics of muscle oxygen consumption will be determined following a brief bout of exercise, followed by a repeated rapid suprasystolic cuffing protocol (Hokanson E20, Bellevue, WA, USA) using a continuous-wave NIRS device (Oxymon MK III, Artinis Medical Systems, The Netherlands)
Timepoint [1] 379569 0
Baseline and 8 weeks after intervention commencement
Secondary outcome [2] 379570 0
Vascular endothelial function- flow mediated dilation (FMD) technique, using duplex Doppler ultrasound (Terason T3200, Burlington, MA, USA).
Timepoint [2] 379570 0
Baseline and 8 weeks after intervention commencement
Secondary outcome [3] 379571 0
A cardiopulmonary exercise test (VO2peak) will be conducted using a metabolic cart.
Timepoint [3] 379571 0
Baseline and 8 weeks after intervention commencement
Secondary outcome [4] 379572 0
6 minute walk test distance will be used as a measure of functional capacity.
Timepoint [4] 379572 0
Baseline and 8 weeks after intervention commencement

Eligibility
Key inclusion criteria
New York Heart Association (NYHA) functional class II-III outpatients will be screened to meet the following inclusion criteria: For heart failure with reduced ejection fraction (HFrEF) - i) history of ischemic or dilated cardiomyopathy, duration of HF symptoms >1 year, ii) stable symptoms > 3 months, iii) left ventricular ejection fraction less than, or equal to 35%, iv) at least one prior hospitalisation due to chronic heart failure (CHF). Patients with chronic heart failure with preserved ejection fraction (HFpEF), as defined by the Framingham criteria with ejection fraction (EF) greater than, or equal to 50% will be included if they have diastolic dysfunction determined by echocardiography (grade equal to, or greater than 1) and sinus rhythm. Healthy participants, with no prior cardiovascular disease, metabolic disease or severe condition limiting exercise capacity (such as moderate to severe respiratory conditions, neurological or musculoskeletal impairments) will be included as matched control participants (for age and sex).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Significant valvular or pericardial disease, infiltrative or hypertrophic cardiomyopathy, cor pulmonale, significant pulmonary disease, and peripheral vascular disease.

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)
Sealed, opaque envelopes will be used to randomise participants with heart failure. Healthy control participants will not take part in any intervention and are only to attend baseline and follow up assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304862 0
University
Name [1] 304862 0
Curtin University
Country [1] 304862 0
Australia
Funding source category [2] 304864 0
Charities/Societies/Foundations
Name [2] 304864 0
Spinnaker Health Research Foundation
Country [2] 304864 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987, Perth WA 6845
Country
Australia
Secondary sponsor category [1] 305203 0
None
Name [1] 305203 0
Address [1] 305203 0
Country [1] 305203 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305273 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 305273 0
Ethics committee country [1] 305273 0
Australia
Date submitted for ethics approval [1] 305273 0
Approval date [1] 305273 0
29/08/2018
Ethics approval number [1] 305273 0
RGS0000001137

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99842 0
Prof Luke Haseler
Address 99842 0
School of Physiotherapy and Exercise Science, Curtin University,
GPO Box U1987, Perth WA 6845
Country 99842 0
Australia
Phone 99842 0
+61 8 9266 3634
Fax 99842 0
Email 99842 0
[email protected]
Contact person for public queries
Name 99843 0
Luke Haseler
Address 99843 0
School of Physiotherapy and Exercise Science, Curtin University,
GPO Box U1987, Perth WA 6845
Country 99843 0
Australia
Phone 99843 0
+61 8 9266 3634
Fax 99843 0
Email 99843 0
[email protected]
Contact person for scientific queries
Name 99844 0
Luke Haseler
Address 99844 0
School of Physiotherapy and Exercise Science, Curtin University,
GPO Box U1987, Perth WA 6845
Country 99844 0
Australia
Phone 99844 0
+61 8 9266 3634
Fax 99844 0
Email 99844 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data collected during the trial underlying published results, after de-identification.
When will data be available (start and end dates)?
After publication, subject to journal's requirements regarding embargo periods, with no end date determined yet.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Data will be available only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by the Principal Investigator, Professor Luke Haseler, School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Fax: +61 8 9266 3699 Telephone: +61 8 9266 3634 Email: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.