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Trial registered on ANZCTR


Registration number
ACTRN12609000365268
Ethics application status
Approved
Date submitted
5/04/2009
Date registered
27/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Aerobic exercise training to improve lung function in children and adolescents with intellectual disability
Scientific title
In children and adolescents with intellectual disability, does aerobic exercise training compared to standard care alone improve lung function?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Learning Disability 4858 0
Condition category
Condition code
Mental Health 4859 4859 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise training: Exercise training sessions of 30 minutes' duration, 5 times per week, for 8 weeks. The exercise modalities were walking and running on flat ground and cycling on a cycle ergometer. Participants conducted 10 minutes of each modality at each training session with no break between modalities. The exercise sessions were supervised by a sports coach. The target intensity was moderate, determined by the sports coach who asked the participants about their level of exertion and also noted that their respiratory rates were elevated but that they could still speak in sentences.
Other usual daily activities were also maintained throughout the duration of the study. These did not include any other specific exercises, and included daily self care, and group activities such as printing, painting, hand craft, and theatre.
Intervention code [1] 4329 0
Treatment: Other
Comparator / control treatment
Usual care: Usual daily activities were maintained throughout the duration of the study. These did not include any specific exercises, and included daily self care, and group activities such as printing, painting, hand craft, and theatre.
Control group
Active

Outcomes
Primary outcome [1] 5713 0
The forced expiratory volume in one second (FEV1), assessed according to American Thoracic Society / European Respiratory Society (2005) criteria, using an electronic spirometer.
Timepoint [1] 5713 0
at baseline and at 8 weeks after intervention commencement
Secondary outcome [1] 241632 0
The forced vital capacity (FVC), assessed according to American Thoracic Society / European Respiratory Society (2005) criteria, using an electronic spirometer.
Timepoint [1] 241632 0
at baseline and at 8 weeks after intervention commencement

Eligibility
Key inclusion criteria
Intellectual disability
Physician approval to exercise
Minimum age
8 Years
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
major motor, behavioural, cardiovascular or respiratory conditions

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)
Eligibility was first confirmed by one investigator. Following confirmation of eligibility, enrollment, and baseline measurements, a second investigator (who was not involved in assessment of eligibility or enrollment or baseline measurements) flipped a coin to randomly allocate each participant to one of the two treatment groups. Therefore the first investigator (who decided whether a subject was eligible for inclusion in the trial) was unaware when that decision was made to which group the subjects would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin toss
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1719 0
Iran, Islamic Republic Of
State/province [1] 1719 0
Semnan

Funding & Sponsors
Funding source category [1] 4754 0
Self funded/Unfunded
Name [1] 4754 0
Address [1] 4754 0
Country [1] 4754 0
Primary sponsor type
University
Name
Semnan University
Address
Physiotherapy Department, Faculty of Rehabilitation, Semnan University of Medical Sciences, Dameghan Road, Semnan
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 4293 0
None
Name [1] 4293 0
Address [1] 4293 0
Country [1] 4293 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7120 0
Ethics Committee of the Shafa Rehabilitation Centre
Ethics committee address [1] 7120 0
No 224, The Shafa Rehabilitation Centre,
17 Shahrivar Ave,
Semnan
Ethics committee country [1] 7120 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 7120 0
Approval date [1] 7120 0
27/03/2008
Ethics approval number [1] 7120 0
14-E

Summary
Brief summary
The primary purpose of the randomised controlled trial element of this research is to determine whether exercise training can improve lung function in children with intellectual disability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29466 0
Address 29466 0
Country 29466 0
Phone 29466 0
Fax 29466 0
Email 29466 0
Contact person for public queries
Name 12713 0
Dr Mark Elkins
Address 12713 0
Department of Respiratory Medicine, Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050
Country 12713 0
Australia
Phone 12713 0
+61 2 95158712
Fax 12713 0
+61 2 95158196
Email 12713 0
elkinsm@med.usyd.edu.au
Contact person for scientific queries
Name 3641 0
Dr Mark Elkins
Address 3641 0
Department of Respiratory Medicine, Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050
Country 3641 0
Australia
Phone 3641 0
+61 2 95158712
Fax 3641 0
+61 2 95158196
Email 3641 0
elkinsm@med.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary