Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000050752
Ethics application status
Approved
Date submitted
20/10/2021
Date registered
17/01/2022
Date last updated
17/01/2022
Date data sharing statement initially provided
17/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Exercise Prescription and Delivery in Congenital Heart Disease – The Congenital Heart Fitness Intervention Trial: CH-FIT
Scientific title
The Effect of Exercise Prescription and Delivery in Congenital Heart Disease – The Congenital Heart Fitness Intervention Trial: CH-FIT
Secondary ID [1] 305094 0
Medical Research Future Fund (ARGCHDG000016)
Secondary ID [2] 305096 0
National Heart Foundation of Australia Vanguard Grant (102277)
Universal Trial Number (UTN)
Trial acronym
CH-FIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Heart Disease 323311 0
Fontan circulation 323312 0
Tetralogy of Fallot 323313 0
Transposition of the Great Arteries 323314 0
Hypoplastic Left Heart Syndrome 323315 0
Tricuspid Atresia 323487 0
Condition category
Condition code
Cardiovascular 320878 320878 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 320879 320879 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible participants will be randomised to either a supervised (or partially) physical activity and exercise program of moderate to vigorous intensity, followed by an 8-month maintenance period; or usual care (control) group. Throughout the intervention period, participants in the intervention groups will also receive education to promote a healthy lifestyle. In the intervention groups, a 5-10 minute warm-up and cool down will be performed before and after each session. Adherence will be monitored by recording session attendance. Sessions in the 4-month supervised (or partially supervised) phase will be delivered by exercise professionals (e.g., exercise physiologists, physiotherapists) in small groups.

Adolescents and adults with biventricular congenital heart disease will be randomly allocated to a telehealth exercise training group or usual care group; Fontan participants may also be allocated to a traditional exercise training group. Children will be randomly allocated to a physical activity and exercise training group or usual care group.

The exercise intervention in the traditional exercise group will involve supervised aerobic (e.g., cycling) and resistance exercise (e.g., leg press, chest press) training 3 times a week for 4 months. Sessions will be ~60-75 minutes and supervised by exercise professionals. Aerobic exercise will commence at 40%-50% of heart rate reserve (HRR) and progress to 70%-80% HRR, as tolerated. The resistance exercise component will involve 3 sets of 8-12 repetitions at 60% of one-repetition maximum (1RM) and progressed to 70% 1RM.

The telehealth exercise training group will perform supervised resistance exercise 3 times a week for 4-months on Zoom. Each supervised resistance training session will be ~45-60 minutes in duration. Participants will perform 3 sets of 8-12 repetitions of various exercises using bodyweight or a Gymstick. Resistance exercise intensity and progression will be monitored by rating of perceived exertion on the OMNI scale. Participants in the telehealth exercise training group will also be asked to perform 20 minutes of aerobic exercise training (e.g., walking) independently 3 times a week for 4-months. Aerobic exercise intensity will be monitored by HRR and is consistent with the traditional exercise training group.

Children allocated to the intervention group will participate in a 4-month supervised physical activity and exercise training program. Participants will attend a community or fitness facility once a week for ~90 minutes to perform an interval exercise circuit, practice foundational movement skills and engage in physically active games. The average target exercise intensity for the exercise circuit will be 40%-50% HRR initially and will progress to 70%-80% HRR, as tolerated. In addition, children will be provided with tasks to complete at home (e.g., calf raises) that supplements the physical activity program and promotes a healthy lifestyle.

During the 8-month maintenance phase, adolescent and adult participants allocated in the exercise intervention groups will be encouraged to continue exercise training independently at least 2 times a week. Children will be encouraged to be physically active and join sports clubs. Follow-up phone calls will be conducted monthly to facilitate ongoing physical activity participation.

Participants in the usual care group will continue with routine clinical care and attend testing visits at baseline, 4-months, and 12-months.
Intervention code [1] 321506 0
Treatment: Other
Intervention code [2] 321507 0
Lifestyle
Intervention code [3] 321508 0
Rehabilitation
Comparator / control treatment
Participants allocated to the control group will continue with routine clinical care as directed by their medical team.
Control group
Active

Outcomes
Primary outcome [1] 328673 0
Change in peak oxygen uptake assessed by cardiopulmonary exercise testing
Timepoint [1] 328673 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [1] 399919 0
Changes in cardiopulmonary exercise testing measures analysed by a metabolic cart
Timepoint [1] 399919 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [2] 399975 0
Changes in respiratory muscle function (only in Fontan participants) assessed by pulmonary function testing instruments (via maximal static inspiratory and expiratory pressures).
Timepoint [2] 399975 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [3] 399976 0
Changes in body composition measured by dual-energy x-ray absorptiometry
Timepoint [3] 399976 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [4] 399977 0
Changes in liver stiffness measure by liver elastography (only in Fontan participants)
Timepoint [4] 399977 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [5] 401922 0
Changes in neurocognitive function assessed using Cogstate
Timepoint [5] 401922 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [6] 401923 0
Changes in near-infrared spectroscopy measures including deoxy hemoglobin, oxyhemoglobin, and skeletal muscle oxidative capacity (composite outcome).
Timepoint [6] 401923 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [7] 401925 0
Changes in physical activity levels measured by accelerometers
Timepoint [7] 401925 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [8] 401927 0
Changes in vascular function assessed by flow-mediated dilation (only in Fontan participants)
Timepoint [8] 401927 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [9] 401928 0
Change in NT-proBNP assessed using standard (serum) assays.
Timepoint [9] 401928 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [10] 401929 0
Changes in cardiac function assessed by transthoracic echocardiography (only in Fontan participants)
Timepoint [10] 401929 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [11] 401930 0
Changes in cardiac function assessed by resting and exercise cardiac MRI (only in Fontan participants)
Timepoint [11] 401930 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [12] 401931 0
Changes in health-related quality of life assessed by PedsQL
Timepoint [12] 401931 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [13] 401933 0
Changes in health economics and patient costs assessed by data-linkage to medicare, CHU-9D and EQ5D.
Timepoint [13] 401933 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [14] 404551 0
Changes lung function (only in Fontan participants) assessed by pulmonary function testing instruments (via spirometry and body plethysmography).
Timepoint [14] 404551 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [15] 404552 0
Changes in handgrip strength (in children, adolescents, and adults) assessed by a hand-grip dynamometer.
Timepoint [15] 404552 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [16] 404553 0
Changes in one-repetition maximum assessed by one-repetition maximum testing (in adolescents and adults).
Timepoint [16] 404553 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [17] 404554 0
Changes in and muscular endurance assessed by musculoskeletal endurance testing (in adolescents and adults).
Timepoint [17] 404554 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [18] 404555 0
Changes in the number of push-ups performed (in children).
Timepoint [18] 404555 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [19] 404556 0
Changes in standing long jump distance (in children).
Timepoint [19] 404556 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [20] 404557 0
Changes in dietary and nutrition intake assessed by the ASA24.
Timepoint [20] 404557 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [21] 404558 0
Changes in malnutrition assessed by the SGA or SGNA
Timepoint [21] 404558 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [22] 404559 0
Changes in energy expenditure assessed by and indirect calorimetry.
Timepoint [22] 404559 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).
Secondary outcome [23] 404560 0
Changes in gastrointestinal symptoms assessed by the GSRS.
Timepoint [23] 404560 0
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Eligibility
Key inclusion criteria
-Aged 10 to 55 years
-People with congenital heart disease of moderate or great complexity
-At least 6 months post surgical repair
-Medically stable and on stable therapy for at least 3 months
Minimum age
10 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Physiological stage D
-Planned intervention within 2 years
-Mental or physical disability that prevents participation in exercise training
-Current or actively planned pregnancy within one year
-Uncontrolled (systemic) hypertension at rest of exercise
-Clinically unstable or recent major change in therapy within 3 months
-COVID-19 unvaccinated people despite being eligible according to ATAGI
-People with unreliable internet connection
-People currently participating in more than 30 minutes of sports or exercise training three times a week

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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 20324 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 20328 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 20329 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [4] 20330 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [5] 20331 0
Perth Children's Hospital - Nedlands
Recruitment hospital [6] 20332 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [7] 20333 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [8] 20462 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 35079 0
2050 - Camperdown
Recruitment postcode(s) [2] 35081 0
3050 - Parkville
Recruitment postcode(s) [3] 35082 0
4032 - Chermside
Recruitment postcode(s) [4] 35083 0
6150 - Murdoch
Recruitment postcode(s) [5] 35084 0
6009 - Nedlands
Recruitment postcode(s) [6] 35085 0
2145 - Westmead
Recruitment postcode(s) [7] 35086 0
4101 - South Brisbane
Recruitment postcode(s) [8] 35910 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 309492 0
Government body
Name [1] 309492 0
National Health & Medical Research Council, the Medical Research Future Fund (MRFF) – Congenital Heart Disease
Country [1] 309492 0
Australia
Funding source category [2] 309518 0
Charities/Societies/Foundations
Name [2] 309518 0
Additional Ventures
Country [2] 309518 0
United States of America
Funding source category [3] 309519 0
Charities/Societies/Foundations
Name [3] 309519 0
Vanguard grants - Heart Foundation, Australia
Country [3] 309519 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 310463 0
None
Name [1] 310463 0
Address [1] 310463 0
Country [1] 310463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309277 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 309277 0
Ethics committee country [1] 309277 0
Australia
Date submitted for ethics approval [1] 309277 0
25/06/2021
Approval date [1] 309277 0
03/09/2021
Ethics approval number [1] 309277 0
Protocol no. X21-0224 & 2021/ETH01181

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

Contacts
Principal investigator
Name 113598 0
Dr Rachel Cordina
Address 113598 0
Suite 303 - RPAH Medical Centre 100 Carillon Ave Newtown NSW 2042
Country 113598 0
Australia
Phone 113598 0
+61 2 9517 4828
Fax 113598 0
Email 113598 0
[email protected]
Contact person for public queries
Name 113599 0
Derek Tran
Address 113599 0
ROYAL PRINCE ALFRED HOSPITAL
Cardiovascular Research Precinct | Department of Cardiology
Level 6 Missenden Road, Camperdown NSW 2050
Country 113599 0
Australia
Phone 113599 0
+61 2 8627 8644
Fax 113599 0
Email 113599 0
[email protected]
Contact person for scientific queries
Name 113600 0
Derek Tran
Address 113600 0
ROYAL PRINCE ALFRED HOSPITAL
Cardiovascular Research Precinct | Department of Cardiology
Level 6 Missenden Road, Camperdown NSW 2050
Country 113600 0
Australia
Phone 113600 0
+61 2 8627 8644
Fax 113600 0
Email 113600 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


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.