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Trial registered on ANZCTR
Registration number
ACTRN12625000076471
Ethics application status
Approved
Date submitted
21/11/2024
Date registered
24/01/2025
Date last updated
24/01/2025
Date data sharing statement initially provided
24/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
RESIST-HF: A randomised controlled trial of a comprehensive nurse-coordinated home-based Resistance ExerciSe program to Improve frailty and phySical funcTion in adults with Heart Failure
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Scientific title
RESIST-HF: A randomised controlled trial of a comprehensive nurse-coordinated home-based Resistance ExerciSe program to Improve frailty and phySical funcTion in adults with Heart Failure
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Secondary ID [1]
312553
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Nil
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Universal Trial Number (UTN)
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Trial acronym
RESIST-HF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
heart failure
334448
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frailty
334451
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Condition category
Condition code
Cardiovascular
331070
331070
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0
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Other cardiovascular diseases
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Physical Medicine / Rehabilitation
331071
331071
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention: Usual care + the RESIST-HF intervention. The RESIST-HF intervention is a three-month nurse-coordinated home-based resistance band exercise program with regular telephone support for the first eight weeks, followed by four weeks of participant maintenance. After enrolment and randomisation, the research nurse will provide all intervention participants with a RESIST-HF intervention pack. The RESIST-HF pack will include:
• Three stretch resistance bands (light, medium and heavy resistance)
• Exercise information cards with pictures and instructions for resistance band exercises, including seated or standing chest pulls and seated bicep curls.
• Links to readily available YouTube resources.
• A copy of the Heart Foundation resource ‘How to Eat Well for a Healthy Heart’
Participants will undertake the self-paced exercise program at home. Participants will be instructed to complete the resistance band exercises at least 2-3 times per week. Level intensity can be increased or changed by using a different resistance band level. The participant will self-report their intensity level (i.e., this will not be measured using an assessment tool).
This study involves a home-based lifestyle intervention. All resistance band exercises can be performed at the participant's own pace at home and at their comfort level. All exercises are adaptable and can be performed in the chair if needed. Participants will be provided information about safety and steps to take should they feel dizzy or unwell, as per standard procedure when undertaking exercise.
Telephone support: After the resistance band exercise program commences, the HF research nurses will follow up with the participant via weekly phone calls for eight weeks to provide support and guidance. The participant will then continue the intervention independently for four more weeks.
Adherence: During the weekly telephone calls, the research nurse will ask the participants if they could follow the resistance band program this week, how often they have undertaken resistance band exercises in the past week and at what intensity level.
Intervention fidelity will be maintained by shared training sessions for the HF research nurses delivering the intervention. Before the study commencement, the research nurses at each site will all undergo an online training course (6 hours duration) accredited by Physical Activity Australia regarding using resistance bands for older adults. The research nurses will also have regular meetings with the Accredited Exercise Physiologist study investigators and Coordinating Principal Investigator in the study to improve their knowledge in delivering supportive exercise programs.
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Intervention code [1]
329538
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Lifestyle
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Intervention code [2]
330126
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Behaviour
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Intervention code [3]
330127
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Rehabilitation
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Comparator / control treatment
Usual heart failure care is as per the study site's standard procedure. Usual heart failure care involves multidisciplinary teams (MDTs) comprising various clinicians, e.g., physicians, specialist nurses, nurse practitioners, and allied health professionals. MDTs provide heart failure medication management and titration plans, fluid restriction management, home outreach visits and psychosocial support.
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Control group
Active
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Outcomes
Primary outcome [1]
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Hospital readmission rate
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Assessment method [1]
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Patient-reported using study-specific questionnaire via telephone interview or extracted from the participant's electronic medical record
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Timepoint [1]
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6 months post study commencement
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Secondary outcome [1]
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Physical frailty
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Assessment method [1]
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The Survey of Health, Ageing, and Retirement Frailty Index (SHARE-FI) score
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Timepoint [1]
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Baseline and 3 months post study commencement
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Secondary outcome [2]
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Physical function
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Assessment method [2]
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Short Physical performance battery
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Timepoint [2]
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Baseline and 3 months post study commencement
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Secondary outcome [3]
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Heart failure symptoms
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Assessment method [3]
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NHYA Functional Class
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Timepoint [3]
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Baseline and 3 months post study commencement
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Secondary outcome [4]
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Number of cardiac-related readmissions
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Assessment method [4]
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Patient-reported using study-specific questionnaire via telephone interview or extracted from the participant's electronic medical record
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Timepoint [4]
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6 months post study commencement
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Secondary outcome [5]
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Mortality rate
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Assessment method [5]
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Medical record review
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Timepoint [5]
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6 months post study commencement
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Secondary outcome [6]
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Frailty
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Assessment method [6]
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The FRAIL scale
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Timepoint [6]
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Baseline and 6 months post study commencement
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Secondary outcome [7]
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Quality-of-life
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Assessment method [7]
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EuroQoL-5D-5L
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Timepoint [7]
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Baseline and 3 months post study commencement
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Secondary outcome [8]
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Depression
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Assessment method [8]
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Depression in Medical illness-10 questionnaire
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Timepoint [8]
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Baseline and 3 months post study commencement
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Secondary outcome [9]
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Heart Failure Needs
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Assessment method [9]
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Heart Failure Needs Assessment Questionnaire
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Timepoint [9]
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Baseline and 3 months post study commencement
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Secondary outcome [10]
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Heart failure symptoms
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Assessment method [10]
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Kansas City Cardiomyopathy Questionnaire-12
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Timepoint [10]
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Baseline and 3 months post study commencement
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Eligibility
Key inclusion criteria
Adults with diagnosed heart failure who present to an outpatient heart failure clinic at the study sites
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• <18 years of age.
• Non-independent living (i.e. high-care residential aged care).
• Listed for heart transplantation.
• Unstable coronary artery disease and/or scheduled for cardiac surgery within the next 3 months.
• On end-of-life care measures/ palliative care.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
31/01/2025
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Actual
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Date of last participant enrolment
Anticipated
31/01/2026
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Actual
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Date of last data collection
Anticipated
31/07/2026
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Office of Health and Medical Research NSW
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
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Government body
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Name [2]
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Office of Health and Medical Research
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Address [2]
317436
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Country [2]
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Australia
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Primary sponsor type
Individual
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Name
Dr Julee McDonagh, University of Wollongong, NSW, Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
320339
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Country [1]
320339
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Other collaborator category [1]
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University
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Name [1]
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University of Wollongong
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Address [1]
283196
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Country [1]
283196
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315734
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Western Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
315734
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https://www.wslhd.health.nsw.gov.au/Education-Portal/Research/ethics-governance
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
315734
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17/10/2024
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Approval date [1]
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19/11/2024
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Ethics approval number [1]
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2024/ETH02338
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Summary
Brief summary
This study aims to make people with heart failure feel stronger, improve their physical function, and keep them out of hospital. We hypothesise that a home-based nurse-coordinated program embedding resistance exercise and healthy eating advice will reduce hospital admission rates at 6 months and lead to improvements in frailty, physical functioning, and quality of life scores at 3 months in adults living with HF. Heart failure affects 1-2% of the Australian population, resulting in a significant number of hospital admissions and placing a huge burden on the NSW health system. Approximately half of those with heart failure will also develop frailty, a devastating syndrome of ‘accelerated ageing’, putting them at even greater risk of adverse events and hospitalisation. This project uses a randomised controlled trial study design to test whether a three-month comprehensive nurse-coordinated home-based exercise program can reduce hospital admissions for adults with heart failure and improve their frailty, physical function, and quality of life.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Julee McDonagh
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Address
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Centre for Chronic and Complex Care Research, Blacktown Hospital, 18 Blacktown Road, Blacktown, 2148, NSW, Australia
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Country
135642
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Australia
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Phone
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+61 2 4239 4577
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Fax
135642
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Email
135642
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jmcdonagh@uow.edu.au
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Contact person for public queries
Name
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Julee McDonagh
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Address
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Centre for Chronic and Complex Care Research, Blacktown Hospital, 18 Blacktown Road, Blacktown, 2148, NSW, Australia
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Country
135643
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Australia
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Phone
135643
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+61 2 4239 4577
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Fax
135643
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Email
135643
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jmcdonagh@uow.edu.au
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Contact person for scientific queries
Name
135644
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Julee McDonagh
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Address
135644
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Centre for Chronic and Complex Care Research, Blacktown Hospital, 18 Blacktown Road, Blacktown, 2148, NSW, Australia
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Country
135644
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Australia
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Phone
135644
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+61 2 4239 4577
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Fax
135644
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Email
135644
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jmcdonagh@uow.edu.au
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
IPD is not available due to privacy concerns and local health district policy
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.
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