Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000753651
Ethics application status
Approved
Date submitted
17/11/2005
Date registered
17/11/2005
Date last updated
5/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The difference between resistance and aerobic training on physical and perceived outcomes in adolescents with chronic fatigue syndrome. A pilot study.
Scientific title
The difference between resistance and aerobic training on physical and perceived outcomes in adolescents with chronic fatigue syndrome. A pilot study.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Fatigue Syndrome 909 0
Condition category
Condition code
Other 975 975 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to complete either progressive resistance training or graded aerobic training for 4 weeks.
Intervention code [1] 762 0
Rehabilitation
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1296 0
An increase in physical strength with no further improvement in fatigue severity.
Timepoint [1] 1296 0
Measured at onset and completion of the 4 week intervention.
Secondary outcome [1] 2323 0
No difference in time to fatigue on treadmill test.
Timepoint [1] 2323 0
Measured at onset and completion of 4 week intervention.
Secondary outcome [2] 2324 0
No difference in subjective measures (Beck's depression index, fatigue severity scale & SF-36).
Timepoint [2] 2324 0
Measured at onset and completion of 4 week intervention.

Eligibility
Key inclusion criteria
Must have CFS.
Minimum age
10 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any pyschological condition or suffer from asthma or any other respiratory disorders.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sealed opaque envelope with intervention written inside randomly chosen by the researcher on admission to the program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Two different intervention groups
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1073 0
Self funded/Unfunded
Name [1] 1073 0
Country [1] 1073 0
Primary sponsor type
Hospital
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 933 0
None
Name [1] 933 0
Nil
Address [1] 933 0
Country [1] 933 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35338 0
Address 35338 0
Country 35338 0
Phone 35338 0
Fax 35338 0
Email 35338 0
Contact person for public queries
Name 9951 0
Brett Gordon
Address 9951 0
Austin Hospital
145 Studley Rd
Heidelberg VIC 3084
Country 9951 0
Australia
Phone 9951 0
+61 3 94965461
Fax 9951 0
Email 9951 0
[email protected]
Contact person for scientific queries
Name 879 0
Brett Gordon
Address 879 0
Austin Hospital
145 Studley Rd
Heidelberg VIC 3084
Country 879 0
Australia
Phone 879 0
+61 3 94965461
Fax 879 0
Email 879 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
No additional documents have been identified.