Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000936820
Ethics application status
Approved
Date submitted
3/09/2012
Date registered
4/09/2012
Date last updated
12/02/2021
Date data sharing statement initially provided
12/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity and exercise in adults with congenital heart disease
Scientific title
The effect of exercise training versus control on vascular endothelial function, cardiorespiratory fitness, strength and quality of life in adults with congenital heart disease
Secondary ID [1] 281136 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital heart disease including patients who have had a Fontan procedure, repaired tetralogy of Fallot, arterial switch operation for transposition of great arteries (including Mustard and Senning procedures), as well as patients with uncorrected congenital heart morphology. 287307 0
Condition category
Condition code
Cardiovascular 287642 287642 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exercise intervention will involve 12 weeks of exercise training involving aerobic and resistance modalities. Training will be performed for approximately one hour, three times a week. Initial sessions will be supervised by an exercise physiologist/physiotherapist and then the participant will exercise independently at a community gymnasium. Aerobic exercise will commence at 50% of the baseline VO2peak and progress to 70% of the VO2peak by the end of the intervention period. Resistance exercise will commence at 50% of the one-repetition maximum and progress to 70% of the one repletion maximum by the end of the intervention period.
Intervention code [1] 285595 0
Rehabilitation
Intervention code [2] 285596 0
Lifestyle
Comparator / control treatment
Control group who maintains usual activities
Control group
Active

Outcomes
Primary outcome [1] 287890 0
Endothelium dependent vasodilator function measured by flow mediated dilation
Timepoint [1] 287890 0
12 weeks
Primary outcome [2] 287891 0
Cardiorespiratory fitness measured by indirect calorimetry during a graded treadmill exercise test
Timepoint [2] 287891 0
12 weeks
Primary outcome [3] 287897 0
Muscular strength measured using the one-repetition maximum technique
Timepoint [3] 287897 0
12 weeks
Secondary outcome [1] 298993 0
Quality of life (SF-36)
Timepoint [1] 298993 0
12 weeks

Eligibility
Key inclusion criteria
Patients aged at least 18 years of age who had previously undergone a Fontan procedure, repaired tetralogy of Fallot, arterial switch operation for transposition of great arteries (including Mustard and Senning procedures), as well as patients with uncorrected congenital heart morphology.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of life-threatening arrhythmias in the absence of an automatic internal cardiac defibrillator

Uncontrolled heart failure (ie, requiring hospitalization and/or intravenous medications within the last month)

Severe aortic stenosis; resting peak systolic gradient >50 mm Hg

Severe pulmonary stenosis, resting peak systolic gradient >50 mm Hg

Severe systemic atrioventricular valve regurgitation

Unmedicated systemic hypertension (>165/100mmHg)

Pregnancy, or planning to become pregnant during the course of the study

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
Completed
Date of first participant enrolment
Anticipated
1/10/2012
Actual
10/10/2012
Date of last participant enrolment
Anticipated
Actual
20/10/2014
Date of last data collection
Anticipated
Actual
19/01/2015
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 285916 0
Hospital
Name [1] 285916 0
Medical Research Foundation, Royal Perth Hospital
Country [1] 285916 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington St
Perth 6000 WA
Country
Australia
Secondary sponsor category [1] 284739 0
University
Name [1] 284739 0
Curtin University
Address [1] 284739 0
Kent St
Bentley 6102 WA
Country [1] 284739 0
Australia
Other collaborator category [1] 277050 0
University
Name [1] 277050 0
University of Western Australia
Address [1] 277050 0
Stirling Highway
Nedlands, 6009 WA
Country [1] 277050 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287945 0
HUMAN RESEARCH ETHICS COMMITTEE, Royal Perth Hospital
Ethics committee address [1] 287945 0
Ethics committee country [1] 287945 0
Australia
Date submitted for ethics approval [1] 287945 0
Approval date [1] 287945 0
07/08/2012
Ethics approval number [1] 287945 0
EC 2012/122

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

Contacts
Principal investigator
Name 34651 0
A/Prof Andrew Maiorana
Address 34651 0
School of Physiotherapy and Exercise Science
Curtin University
Kent Street, Bentley, Perth, Western Australia 6102
Country 34651 0
Australia
Phone 34651 0
+61433567369
Fax 34651 0
Email 34651 0
Andrew.Maiorana@health.wa.gov.au
Contact person for public queries
Name 17898 0
Andrew Maiorana
Address 17898 0
School of Physiotherapy and Exercise Science
Curtin University
Kent Street, Bentley, Perth, Western Australia 6102
Country 17898 0
Australia
Phone 17898 0
+61433567369
Fax 17898 0
+61892241464
Email 17898 0
Andrew.Maiorana@health.wa.gov.au
Contact person for scientific queries
Name 8826 0
Andrew Maiorana
Address 8826 0
School of Physiotherapy and Exercise Science
Curtin University
Kent Street, Bentley, Perth, Western Australia 6102
Country 8826 0
Australia
Phone 8826 0
+61433567369
Fax 8826 0
+61892241464
Email 8826 0
Andrew.Maiorana@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants weren't made aware of the sharing of IPD when they consented to participate in the trial


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10644Study protocol  Andrew.Maiorana@health.wa.gov.au



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.