Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 312553 0
Nil
Universal Trial Number (UTN)
Trial acronym
RESIST-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 334448 0
frailty 334451 0
Condition category
Condition code
Cardiovascular 331070 331070 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 331071 331071 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329538 0
Lifestyle
Intervention code [2] 330126 0
Behaviour
Intervention code [3] 330127 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 339400 0
Hospital readmission rate
Timepoint [1] 339400 0
6 months post study commencement
Secondary outcome [1] 439789 0
Physical frailty
Timepoint [1] 439789 0
Baseline and 3 months post study commencement
Secondary outcome [2] 442033 0
Physical function
Timepoint [2] 442033 0
Baseline and 3 months post study commencement
Secondary outcome [3] 442060 0
Heart failure symptoms
Timepoint [3] 442060 0
Baseline and 3 months post study commencement
Secondary outcome [4] 442061 0
Number of cardiac-related readmissions
Timepoint [4] 442061 0
6 months post study commencement
Secondary outcome [5] 442062 0
Mortality rate
Timepoint [5] 442062 0
6 months post study commencement
Secondary outcome [6] 442063 0
Frailty
Timepoint [6] 442063 0
Baseline and 6 months post study commencement
Secondary outcome [7] 442716 0
Quality-of-life
Timepoint [7] 442716 0
Baseline and 3 months post study commencement
Secondary outcome [8] 442719 0
Depression
Timepoint [8] 442719 0
Baseline and 3 months post study commencement
Secondary outcome [9] 444034 0
Heart Failure Needs
Timepoint [9] 444034 0
Baseline and 3 months post study commencement
Secondary outcome [10] 444035 0
Heart failure symptoms
Timepoint [10] 444035 0
Baseline and 3 months post study commencement

Eligibility
Key inclusion criteria
Adults with diagnosed heart failure who present to an outpatient heart failure clinic at the study sites
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
31/01/2025
Actual
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316980 0
Government body
Name [1] 316980 0
Office of Health and Medical Research NSW
Country [1] 316980 0
Australia
Funding source category [2] 317436 0
Government body
Name [2] 317436 0
Office of Health and Medical Research
Country [2] 317436 0
Australia
Primary sponsor type
Individual
Name
Dr Julee McDonagh, University of Wollongong, NSW, Australia
Address
Country
Australia
Secondary sponsor category [1] 320339 0
None
Name [1] 320339 0
Address [1] 320339 0
Country [1] 320339 0
Other collaborator category [1] 283196 0
University
Name [1] 283196 0
University of Wollongong
Address [1] 283196 0
Country [1] 283196 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315734 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315734 0
https://www.wslhd.health.nsw.gov.au/Education-Portal/Research/ethics-governance
Ethics committee country [1] 315734 0
Australia
Date submitted for ethics approval [1] 315734 0
17/10/2024
Approval date [1] 315734 0
19/11/2024
Ethics approval number [1] 315734 0
2024/ETH02338

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135642 0
Dr Julee McDonagh
Address 135642 0
Centre for Chronic and Complex Care Research, Blacktown Hospital, 18 Blacktown Road, Blacktown, 2148, NSW, Australia
Country 135642 0
Australia
Phone 135642 0
+61 2 4239 4577
Fax 135642 0
Email 135642 0
[email protected]
Contact person for public queries
Name 135643 0
Julee McDonagh
Address 135643 0
Centre for Chronic and Complex Care Research, Blacktown Hospital, 18 Blacktown Road, Blacktown, 2148, NSW, Australia
Country 135643 0
Australia
Phone 135643 0
+61 2 4239 4577
Fax 135643 0
Email 135643 0
[email protected]
Contact person for scientific queries
Name 135644 0
Julee McDonagh
Address 135644 0
Centre for Chronic and Complex Care Research, Blacktown Hospital, 18 Blacktown Road, Blacktown, 2148, NSW, Australia
Country 135644 0
Australia
Phone 135644 0
+61 2 4239 4577
Fax 135644 0
Email 135644 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided 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.