Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000796684
Ethics application status
Approved
Date submitted
27/05/2014
Date registered
28/07/2014
Date last updated
28/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Impact of Exercise on Growth Hormone Deficient Adolescent and Young Adult Survivors of Childhood Cancer: a pilot study
Scientific title
The Impact of Exercise on Metabolic Parameters of Growth Hormone Deficient Adolescent and Young Adult Survivors of Childhood Cancer: A Randomised Cross-Over study
Secondary ID [1] 284673 0
nil known
Universal Trial Number (UTN)
U1111-1157-3978
Trial acronym
GHDEx
Linked study record

Health condition
Health condition(s) or problem(s) studied:
survivor of childhood cancer
 292012 0
growth hormone deficiency 292013 0
Condition category
Condition code
Cancer 292357 292357 0 0
Children's - Other
Metabolic and Endocrine 292358 292358 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exercise program consists of thrice weekly supervised exercise sessions aimed at increasing exercise capacity. Each session will last for about 1 hour and consist of a small group with each participant having a personally tailored program. This will continue for 6 months. Intensity will be monitored during exercise sessions using heart rate monitors and rate of perceived exertion (Borg scale). During the intervention phase, exercise intensity will be maintained in the moderate intensity and not enter into vigorous intensity (>60% VO2R). The key components of the exercise intervention include resistance training to increase lean muscle mass, and aerobic training to increase aerobic fitness. Each exercise program will be fully supervised and designed in accordance with the American College of Sports Medicine (ACSM) guidelines(Franklin BA, Whaley MH, and Howley ET. ACSM's Guidelines for exercise testing and prescription (6 ed.). Philadelphia: Lippincott Williams and Wilkins, 2000). The program will consist of a 10 min warm up period, with light stretching, followed by 30-45 min of a circuit-based program which will use a combination of both endurance (65-85% of HRmax, monitored continuously using a Polar heart rate monitor) and resistance (55-70% maximal voluntary contraction) exercises, and a 10 min cool down. Intensity and duration will be increased, first by extending the number of sets, then by the weight lifted. We have previous experienced high levels of compliance and participation using this form of training in a similar population group, who are young, and generally not highly motivated to participate in physical activities.
Intervention code [1] 289457 0
Lifestyle
Comparator / control treatment
In this study half the participants will be offered the exercise program for the first 6 months while the other half are not offered any program but encouraged to continue with their normal routines. After 6 months the control group will be offered the exercise program and the exercise group will become a control (although their data will be evaluated in the context of having just completed the exercise program). The second group to exercise will also have testing 6 months after their program finishes (ie 18 months into the study so that the washout effect of exercise can be examined in both groups).
Control group
Active

Outcomes
Primary outcome [1] 292211 0
impact of exercise on metabolic parameters including: Oral glucose tolerance test results (analysed using HOMA2 scores), serum HbA1c, fasting lipid profile and auxological data.
Timepoint [1] 292211 0
after 6 months of exercise.
Levels will also be checked after 3 months to identify early changes in parameters and after 12 months to identify hangover effect from the intervention.
Secondary outcome [1] 308414 0
Impact of exercise on cardiovascular parameters:
Every candidate will have an echocardiogram within the 12 months prior to commencing the program. This will be repeated at the end of the 6 month exercise program. Furthermore, endothelial function will be assessed using flow mediated dilation which has been demonstrated to be an independant predictor of cardiac events.
Flow mediated dilation is assessed as follows:
Following a one minute recording of resting brachial artery diameter by ultrasound, a forearm cuff placed distal to the olecranon process, will be inflated to 220mmHg for five minutes. Diameter and blood flow recordings will resume 30 seconds before cuff deflation and continue for three minutes.
Timepoint [1] 308414 0
After 6 months of exercise.
Tests will also be performed after 3 months to identify early changes in parameters and after 12 months to identify hangover effect from the intervention.
Secondary outcome [2] 308415 0
Impact of exercise on psychosocial wellbeing:
A series of psychological assessments will be administered at baseline and again after the exercise intervention. The psychometric battery will include face-to-face assessments and parent-report questionnaires.
Tests used:
Wechsler Abbreviated Scale of Intelligence (WASI)
Test of Everyday Attention (TEA)
Wechsler Memory Scale – 3rd Edition (WMS-III)
Grooved Pegboard
ASEBA Youth Report (YSR)
ASEBA Adult Self-Report (ASR)
Behavior Assessment System for Children – Self-report (BASC-2)
Adaptive Behavior Assessment System – 2nd Edition (ABAS-II)
Behavior Rating Inventory of Executive Function – Adult (BRIEF-A)
PedsQL 4.0 (Generic Version)
Parent-reported questionnaires:
Behavior Assessment System for Children – 2nd Edition, parent-report (BASC-2)
Behavior Rating Inventory of Executive Function (BRIEF)
Timepoint [2] 308415 0
After 6 months of exercise.
Tests will also be performed after 3 months to identify early changes in parameters and after 12 months to identify hangover effect from the intervention.

Eligibility
Key inclusion criteria
1. Survivor of childhood brain cancer or cranial irradiation at a dose sufficient to potentially result in GH deficiency
2. Current age 15-23
Minimum age
15 Years
Maximum age
23 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently on GH therapy
Acutely unwell
Pregnant

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Details of eligable patients are obtained via the oncology and endocrinology databases.
Patients who appear likely fit the inclusion and exclusion criteria are mailed an information letter.
Patients are called 2 weeks later and participation in the trial is proposed.
Willing candidates attend PMH for detailed description of the trial and baseline studies.
Patients are randomised to exercise or non-exercise group using a web-based program.
Crossover of groups occurs after 6 months.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The exercise physiologist contacts central administration ("off-site") who use a web-based program to randomly allocate participants into exercise or control groups (control group being the one who will exercise in the second 6 months)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Half the participants will be assessed at baseline and 6 months later after no intervention. These will act as pure control subjects. They will then commence the exercise intervention and be assessed 3 months into that, at its end and again 6 months later. The other half will be assessed at baseline, 3 months into their exercise program, at the end of the exercise program and 6 months after the intervention.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/03/2014
Actual
13/03/2014
Date of last participant enrolment
Anticipated
18/09/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 8141 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 289296 0
Charities/Societies/Foundations
Name [1] 289296 0
Princess Margaret Hospital Foundation
Country [1] 289296 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital for Children
Address
Roberts Rd, Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 288064 0
University
Name [1] 288064 0
University of Western Australia
Address [1] 288064 0
35 stirling Highway, Crawley WA 6009
Country [1] 288064 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291059 0
Princess Margaret Hospital Human Research Ethics Committee
Ethics committee address [1] 291059 0
Ethics committee country [1] 291059 0
Australia
Date submitted for ethics approval [1] 291059 0
Approval date [1] 291059 0
18/07/2013
Ethics approval number [1] 291059 0
2013059EP

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

Contacts
Principal investigator
Name 48726 0
Dr Shoshana Rath
Address 48726 0
Princess Margaret Hospital (PMH), Roberts Rd Subiaco, WA, 6008
Country 48726 0
Australia
Phone 48726 0
+61 8 93408222
Fax 48726 0
Email 48726 0
[email protected]
Contact person for public queries
Name 48727 0
Shoshana Rath
Address 48727 0
PMH, Roberts Rd Subiaco, WA 6008
Country 48727 0
Australia
Phone 48727 0
+61893408222
Fax 48727 0
Email 48727 0
[email protected]
Contact person for scientific queries
Name 48728 0
Shoshana Rath
Address 48728 0
PMH, Roberts Rd Subiaco, WA 6008
Country 48728 0
Australia
Phone 48728 0
+61893408222
Fax 48728 0
Email 48728 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
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Documents added automatically
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