Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000278336
Ethics application status
Not yet submitted
Date submitted
30/05/2008
Date registered
30/05/2008
Date last updated
30/05/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of acute power and aerobic exercise on bone metabolism in healthy young individuals
Scientific title
The effects of acute power and aerobic exercise on bone metabolism in healthy young individuals
Secondary ID [1] 572 0
N/A
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bone metabolism 3218 0
Condition category
Condition code
Metabolic and Endocrine 3381 3381 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will examine the effects of a single 60 minute exercise session (aerobic or power exercises) on plasma uncarboxylated osteocalcin (unc-OC), adionectine (AN). Blood samples will be taken before exercise, immediately after and at 0.5, 1, 2, 24 and 48 hours post exercise.
Intervention code [1] 2955 0
Other interventions
Comparator / control treatment
N/A
Control group
Active

Outcomes
Primary outcome [1] 4276 0
Uncarboxylated osteocalcin (unc-OC) will be analysed based on a sandwich type electro-chemiluminescence immunoassay (ECLIA) utilizing anti-OCG3 mouse monoclonal antibody labelled with Ruthenium (Ru) which luminates with electric stimuli. Magnetic beads bound to anti GluOC 4-5 mouse monoclonal antibody is used as a solid phase. After binding the unc-OC in the sample with the GluOC4-5 bound beads and Ru labelled OCG3, an electric impulse is applied via an electrode. The level of luminescence for the Ru complexes bound to solid phase antibody reflects the amount of unc-OC in the sample. The concentration of the unc-OC in the sample is measured by comparing the sample's luminescence to that of a calibrated solution of known unc-OC standards
Timepoint [1] 4276 0
before exercise, immediately after and at 0.5, 1, 2, 24 and 48 hours post exercise
Secondary outcome [1] 7204 0
Adiponectin will be measured by ALPCO assay (ALPCO Diagnostics, Salem, NH).
Timepoint [1] 7204 0
before exercise, immediately after and at 0.5, 1, 2, 24 and 48 hours post exercise.

Eligibility
Key inclusion criteria
non-active, healthy young volunteers
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
people with metabolic diseases such as diabetes or osteoporosis. People with cardiovascular disease or those who use any type of prescribed medications

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)
Participants will be recruited mainly from VU students and young staff members and individuals from the western suburbs of Melbourne. All volunteers will receive an explanation about the nature of the study and those who will choose to participate will sign an informed consent document. In addition, participants will complete a health assessment questionnaire. Participants will then be randomly allocated (sealed opaque envelops) into power or aerobic exercise groups . Two different sets of sealed envelopes will be used for men and women to ensure a similar number of men and women in each group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method of randomisation for this study is Stratified allocation. Randomization will be stratified according to sex.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3443 0
University
Name [1] 3443 0
Victoria University
Country [1] 3443 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
School of Human Movement, Recreation & Performance
Victoria University
Ballart Rd
PO Box 14428
Footscray Melbourne VIC 3011
Country
Australia
Secondary sponsor category [1] 3085 0
University
Name [1] 3085 0
Victoria University
Address [1] 3085 0
School of Human Movement, Recreation & Performance
Victoria University
Ballart Rd
PO Box 14428
Footscray Melbourne VIC 3011
Country [1] 3085 0
Australia
Other collaborator category [1] 300 0
Hospital
Name [1] 300 0
Austin Health
Address [1] 300 0
Austin Health Repatriation Campus Waterdale Road Heidelberg West Melbourne VIC 3081
Country [1] 300 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5470 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 5470 0
Office for Research, PO Box 14428, Melbourne, Vic 8001
Ethics committee country [1] 5470 0
Australia
Date submitted for ethics approval [1] 5470 0
28/05/2008
Approval date [1] 5470 0
Ethics approval number [1] 5470 0
HRETH 08120

Summary
Brief summary
The aim of the study is to examine the connection between bone metabolism and glucose homeostasis in healthy young individuals. In addition this project will provide experimental evidence on the effects of power and aerobic exercises on the secretion of osteocalcin, a hormone produced by bones that may also have a role in glucose metabolism. No previous research has examined the role tat bone might play in glucose regulation. This study will add important new information regarding the effects of exercise on bone metabolism and its connection to glucose control.

Specific aim
To examine the acute effects of power and aerobic exercise on bone metabolism in healthy young individuals.

Studies hypotheses

Acute effects of exercise on bone and metabolism
i. An increase in unc-OC will occur as part of the acute response to exercise
ii. Power exercise will result in greater increases in unc-OC, compared to the acute effects of aerobic exercise.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28633 0
Address 28633 0
Country 28633 0
Phone 28633 0
Fax 28633 0
Email 28633 0
Contact person for public queries
Name 11790 0
Itamar Levinger
Address 11790 0
School of Human Movement, Recreation & Performance
Victoria University
Ballart Rd
PO Box 14428
Footscray Melbourne VIC 3011
Country 11790 0
Australia
Phone 11790 0
+61 3 99194499
Fax 11790 0
Email 11790 0
itamar.levinger@vu.edu.au
Contact person for scientific queries
Name 2718 0
Itamar Levinger
Address 2718 0
School of Human Movement, Recreation & Performance
Victoria University
Ballart Rd
PO Box 14428
Footscray Melbourne VIC 3011
Country 2718 0
Australia
Phone 2718 0
+61 3 99194499
Fax 2718 0
Email 2718 0
itamar.levinger@vu.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.