Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000420549
Ethics application status
Approved
Date submitted
9/04/2015
Date registered
4/05/2015
Date last updated
12/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does masters sport participation increase physical, psychological, cognitive and social functioning in recreational cyclists aged over 40 years old?
Scientific title
Does masters sport participation increase physical, psychological, cognitive and social functioning in recreational cyclists aged over 40?
Secondary ID [1] 286497 0
Nil
Universal Trial Number (UTN)
U1111-1169-1408
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-associated decline in physical function 294707 0
Age-associated decline in psychological function 294787 0
Age-associated decline in cognitive function 294788 0
Age-associated decline in social function 294789 0
Condition category
Condition code
Public Health 294999 294999 0 0
Health promotion/education
Mental Health 295066 295066 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cycling training and competition intervention - 1-2 weekly training sessions will be performed by participant with no supervision. One training session per week will take place in a spin cycle theater and supervised by an accredited exercise physiologist

Dose - 2-3 training sessions per week and 1-2 competitions per month;
Intensity of training sessions are yet to be determined and will be determined after initial assessment; anticipated intensity will be 55-75% VO2max.
Number of training sessions per week (2-3) and number of competition per month (1) have been set by cycling coach and will be adapted according to participant availability.
Road cycling competitions are yet to be identified and will depend on group availability and consensus. All competitions range from 40-100kms.

Duration of intervention - 12 weeks

Mode of administration - qualified cycling coach will monitor training load via recorded heart rate data, training diaries, phone calls, emails, text messages
Intervention code [1] 291591 0
Lifestyle
Intervention code [2] 291648 0
Prevention
Comparator / control treatment
Control group 1 - recreational masters cyclists who continue usual cycling activities (i.e. cycling activities that the participant would do under normal circumstance)

Control group 2 - physically inactive individuals who continue usual daily activities (i.e. activities that the participant would do under normal circumstances)
Control group
Active

Outcomes
Primary outcome [1] 294755 0
Physical functioning using the Veterans Rand 12 item health survey (VR-12)



Timepoint [1] 294755 0
Survey will be implemented at two time points: once at baseline (week 1) and once at final follow up (post intervention - week 12)
Primary outcome [2] 294756 0
Mental function using the Medical Outcomes Study Cognitive Functioning 6 item scale (MOS-CF 6) and Veterans Rand 12 item health survey (VR-12)


Timepoint [2] 294756 0
Survey will be implemented at two time points: once at baseline (week 1) and once at final follow up (post intervention - week 12)
Primary outcome [3] 294757 0
Social functioning using the short loneliness 3 item scale
Timepoint [3] 294757 0
Survey will be implemented at two time points: once at baseline (week 1) and once at final follow up (post intervention - week 12)
Secondary outcome [1] 313997 0
Successful ageing is a multidimensional latent variable which will be defined by physical, psychological, cognitive and social domains and assessed via functional criteria in each of these domains.

Physical and mental function will be assessed by Veterans Rand 12 item health survey (VR-12)

Cognitive function will be assessed by MOS - CF scale

Social function will be assessed by the short loneliness 3 item scale
Timepoint [1] 313997 0
Survey will be implemented at two time points: once at baseline (week 1) and once at final follow up (post intervention - week 12)Pre-intervention and post-intervention

Eligibility
Key inclusion criteria
Male or female
Over 40 years old
Recreational cyclist
No structured training or competition in the previous 10 years
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medically unfit for exercise

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by Statistical Package for the Social Sciences (SPSS v. 22)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/06/2015
Actual
8/06/2015
Date of last participant enrolment
Anticipated
Actual
6/07/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291066 0
University
Name [1] 291066 0
Central Queensland University
Country [1] 291066 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Bruce Highway North Rockhampton QLD 4702
Country
Australia
Secondary sponsor category [1] 289747 0
None
Name [1] 289747 0
Address [1] 289747 0
Country [1] 289747 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292650 0
CQUniversity Human Research Ethics Committee
Ethics committee address [1] 292650 0
Ethics committee country [1] 292650 0
Australia
Date submitted for ethics approval [1] 292650 0
02/04/2015
Approval date [1] 292650 0
Ethics approval number [1] 292650 0
Ethics committee name [2] 294808 0
CQUniversity Human Research Ethics Committee
Ethics committee address [2] 294808 0
Ethics committee country [2] 294808 0
Australia
Date submitted for ethics approval [2] 294808 0
26/05/2015
Approval date [2] 294808 0
02/06/2015
Ethics approval number [2] 294808 0
H15/03-051

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

Contacts
Principal investigator
Name 56386 0
Mr David Geard
Address 56386 0
CQUniversity Building 81 Bruce Highway North Rockhampton QLD 4702
Country 56386 0
Australia
Phone 56386 0
+61 7 49232548
Fax 56386 0
Email 56386 0
d.geard@cqu.edu.au
Contact person for public queries
Name 56387 0
David Geard
Address 56387 0
CQUniversity Building 81 Bruce Highway North Rockhampton QLD 4702
Country 56387 0
Australia
Phone 56387 0
+61 7 49232548
Fax 56387 0
Email 56387 0
d.geard@cqu.edu.au
Contact person for scientific queries
Name 56388 0
David Geard
Address 56388 0
CQUniversity Building 81 Bruce Highway North Rockhampton QLD 4702
Country 56388 0
Australia
Phone 56388 0
+61 7 49232548
Fax 56388 0
Email 56388 0
d.geard@cqu.edu.au

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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4534Study results articleYes Effects of a 12-week cycling intervention on succe... [More Details]

Documents added automatically
No additional documents have been identified.