Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000263392
Ethics application status
Approved
Date submitted
29/02/2008
Date registered
23/05/2008
Date last updated
6/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A supervised exercise programme following hospitalisation for heart failure: does it add to disease management?
Scientific title
The impact of a disease management programme including a supervised exercise programme versus disease management alone on death, readmissions, depression and functional status in patients with a recent hospitalisation for heart failure
Secondary ID [1] 281138 0
Heart failure exercise study
Universal Trial Number (UTN)
Trial acronym
EJECTION:HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 2895 0
Condition category
Condition code
Cardiovascular 3030 3030 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A supervised exercise programme consisting of 36 one hour sessions of gym-based aerobic and resistance exercise over 6 months with active encouragement of home based exercise, administered in addition to an established disease management programme including education, early review, telephone and outreach support and optimal drug titration
Intervention code [1] 2625 0
Treatment: Other
Comparator / control treatment
An established disease management programme including education, early review, telephone and outreach support and optimal drug titration, as well as standard exercise advice
Control group
Active

Outcomes
Primary outcome [1] 3911 0
Death or readmission
Timepoint [1] 3911 0
12 months post commencement of study program
Primary outcome [2] 238158 0
Depressive symptoms using the Geriatric Depression Scale and the Cardiac Depression Scale
Timepoint [2] 238158 0
3 and 6 months post commencement of study program
Secondary outcome [1] 6586 0
Time to first readmission
Timepoint [1] 6586 0
12 months post commencement of study program
Secondary outcome [2] 242431 0
Time to first heart failure related readmission
Timepoint [2] 242431 0
12 months post commencement of study program
Secondary outcome [3] 242432 0
Number of hospitalisations
Timepoint [3] 242432 0
12 months post commencement of study program
Secondary outcome [4] 242433 0
Hospital bed days occupied
Timepoint [4] 242433 0
12 months post commencement of study program
Secondary outcome [5] 242434 0
Days alive out of hospital
Timepoint [5] 242434 0
12 months post commencement of study program
Secondary outcome [6] 242435 0
Adherence rates to exercise classes and education sesions
Timepoint [6] 242435 0
6 months post commencement of study program
Secondary outcome [7] 242436 0
Exercise adherence
Timepoint [7] 242436 0
3 and 6 months post commencement of study program
Secondary outcome [8] 242437 0
Walking capacity
Timepoint [8] 242437 0
3 and 6 months post commencement of study program
Secondary outcome [9] 242438 0
Functional decline
Timepoint [9] 242438 0
6 months post commencement of study program
Secondary outcome [10] 242439 0
Quality of life using the Australian Quality of Life questionnaire.
Timepoint [10] 242439 0
6 months post commencement of study program
Secondary outcome [11] 242440 0
Programme costs - direct and indirect program costs including costs of readmissions, outpatient attendances and emergency department visits. Hospitalisations will be confirmed using the Queensland Hospitals Admitted patient Data Collection. Emergency department data will be recorded using the online Emergency Department Information Service.
Timepoint [11] 242440 0
12 months post commencement of study program
Secondary outcome [12] 242441 0
Quality of sleep using the Pittsburgh Sleep Quality Index.
Timepoint [12] 242441 0
3 months post commencement of study program.

Eligibility
Key inclusion criteria
Less than or equal to 6 weeks post acute admission to hospital with symptomatic congestive heart failure as dominant clinical diagnosis. Evidence during admission of clinically significant criteria: including documented symptoms (dyspnoea, fatigue, and/or peripheral oedema) and signs (raised jugular venous pressure, displaced apex beat, 3rd heart sound, and/or crepitations on chest examination). Chest xray changes (pulmonary venous congestion, pulmonary oedema and cardiomegaly) or current/past echocardiography evidence of left ventricular dysfunction. Echocardiography within 6 months. On medical therapy for heart failure. Able to regularly attend the duration of the programme and all follow-ups. Satisfy safety criteria; Signed written informed consent; Aged 18 years or older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Terminally ill. Serious cognitive impairment. Serious other physical impairment which prevents attendance and participation. Implantable cardioverter defibrillator insertion < 4 weeks preceding programme. Cardiac re-synchonisation therapy < 6 months preceding programme. Awaiting cardiovascular procedure or hospitalisation for surgery. Exercise testing results or clinical judgement by the exercise specialist that would preclude safe exercise training participation. Completed a full 12 week regime of formal exercise rehabilitation in the past 12 month period.

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 using computer random number generation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generation in permuted blocks stratified by site
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/05/2008
Actual
13/05/2008
Date of last participant enrolment
Anticipated
30/12/2010
Actual
22/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2802 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 2803 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 2804 0
Logan Hospital - Meadowbrook
Recruitment hospital [4] 2805 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 2806 0
Ipswich Hospital - Ipswich
Recruitment postcode(s) [1] 784 0
4029
Recruitment postcode(s) [2] 785 0
4032
Recruitment postcode(s) [3] 786 0
4102
Recruitment postcode(s) [4] 8494 0
4131 - Meadowbrook
Recruitment postcode(s) [5] 8495 0
4305 - Ipswich

Funding & Sponsors
Funding source category [1] 3145 0
Government body
Name [1] 3145 0
National Health and Medical Research Council (NHMRC)
Country [1] 3145 0
Australia
Funding source category [2] 3146 0
Charities/Societies/Foundations
Name [2] 3146 0
Royal Brisbane and Women's Hospital (RBWH) Foundation
Country [2] 3146 0
Australia
Funding source category [3] 3147 0
Charities/Societies/Foundations
Name [3] 3147 0
The Prince Charles Hospital Foundation
Country [3] 3147 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Alison Mudge
Address
Department of Internal Medicine and Aged Care
3rd floor
James Mayne Building
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 2823 0
Charities/Societies/Foundations
Name [1] 2823 0
RBWH Foundation
Address [1] 2823 0
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country [1] 2823 0
Australia
Other collaborator category [1] 217 0
Individual
Name [1] 217 0
Associate Professor Charles Denaro
Address [1] 217 0
Department of Internal Medicine and Aged Care
3rd floor
James Mayne Building
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country [1] 217 0
Australia
Other collaborator category [2] 218 0
Individual
Name [2] 218 0
Dr George Javorsky
Address [2] 218 0
Heart Failure and Transplantation Unit
The Prince Charles Hospital
Rode Rd
Chermside QLD 4032
Country [2] 218 0
Australia
Other collaborator category [3] 219 0
Individual
Name [3] 219 0
Dr Adam Scott
Address [3] 219 0
Cardiology Department
3rd floor
James Mayne Building
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country [3] 219 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5122 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 5122 0
Ethics committee country [1] 5122 0
Australia
Date submitted for ethics approval [1] 5122 0
Approval date [1] 5122 0
01/02/2008
Ethics approval number [1] 5122 0
2008/001
Ethics committee name [2] 5123 0
The Prince Charles Hospital HREC
Ethics committee address [2] 5123 0
Ethics committee country [2] 5123 0
Australia
Date submitted for ethics approval [2] 5123 0
Approval date [2] 5123 0
16/08/2007
Ethics approval number [2] 5123 0
EC2722
Ethics committee name [3] 239233 0
Princess Alexandra Hospital HREC
Ethics committee address [3] 239233 0
Ethics committee country [3] 239233 0
Australia
Date submitted for ethics approval [3] 239233 0
16/04/2009
Approval date [3] 239233 0
08/05/2009
Ethics approval number [3] 239233 0
2009/100
Ethics committee name [4] 239234 0
Gold Coast Hospital HREC
Ethics committee address [4] 239234 0
Ethics committee country [4] 239234 0
Australia
Date submitted for ethics approval [4] 239234 0
15/04/2009
Approval date [4] 239234 0
Ethics approval number [4] 239234 0
New ethics HREC. Please modify.

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

Contacts
Principal investigator
Name 28416 0
Prof Alison Mudge
Address 28416 0
Internal Medicine and Aged Care
3rd floor James Mayne Building
Royal Brisbane and Women's Hospitals
Butterfield St
Herston Qld 4029
Country 28416 0
Australia
Phone 28416 0
61736460854
Fax 28416 0
Email 28416 0
[email protected]
Contact person for public queries
Name 11573 0
Jessica Suna
Address 11573 0
Internal Medicine Research Unit
Level 7, Block 7
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 11573 0
Australia
Phone 11573 0
+61 7 3646 6207
Fax 11573 0
+61 7 3646 6943
Email 11573 0
[email protected]
Contact person for scientific queries
Name 2501 0
Alison Mudge
Address 2501 0
Department of Internal Medicine and Aged Care
3rd floor
James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4051
Country 2501 0
Australia
Phone 2501 0
+61 7 3646 0854
Fax 2501 0
+61 7 3646 6943
Email 2501 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseFrailty implications for exercise participation and outcomes in patients with heart failure.2021https://dx.doi.org/10.1111/jgs.17145
N.B. These documents automatically identified may not have been verified by the study sponsor.