Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001399482
Ethics application status
Approved
Date submitted
5/10/2016
Date registered
10/10/2016
Date last updated
11/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Profiling skeletal muscle loss during leg immobilisation
Scientific title
The injured athlete: genetic profiling of skeletal muscle atrophy with limb immobilisation
Secondary ID [1] 290270 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skeletal muscle atrophy 300503 0
Condition category
Condition code
Musculoskeletal 300360 300360 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
14 days of limb (leg) immobilisation and unloading will be undertaken using a Donjoy X-ACT ROM Universal leg brace to be worn for 24 h, Adherence will be monitored through actigraph accelerometers to determine physical activity levels and a unique
identifier on tape wrapped around to the brace will determine if/when a brace is removed. Muscle biopsies and venous blood samples will be obtained on day 0, 3 and 14.
Intervention code [1] 296067 0
Treatment: Other
Comparator / control treatment
No control group; within participant design using contra-lateral control limb for comparison
Control group
Active

Outcomes
Primary outcome [1] 299814 0
Changes in quadriceps muscle mass quantified by MRI and DEXA scans
Timepoint [1] 299814 0
Baseline (Day 0), day 3 and day 14 measurements
Primary outcome [2] 299828 0
Exploratory genetic analysis using RNA sequencing will be undertaken to better understand RNA expression changes in blood and muscle tissue samples due to immobilization induced atrophy.
Timepoint [2] 299828 0
Day 0 and day 14
Secondary outcome [1] 328194 0
Change in muscle strength as determined by isometric and isoinertial testing
Timepoint [1] 328194 0
Baseline (day 0) and day 14

Eligibility
Key inclusion criteria
Physically active individuals undertaking 5 h per week of moderate-vigorous exercise
Minimum age
20 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Recent (<6 months) injury requiring immobilsation, medical conditions that would place participants at increased risk during
exercise, currently taking medications known to affect body composition, employment requiring physical labour.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Repeated measures ANOVA and RNA sequencing biostatistics

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/10/2016
Actual
17/10/2016
Date of last participant enrolment
Anticipated
5/06/2017
Actual
8/05/2017
Date of last data collection
Anticipated
28/07/2017
Actual
1/07/2017
Sample size
Target
40
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294636 0
Government body
Name [1] 294636 0
Department of Education and Training
Country [1] 294636 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Drive
ROBINA QLD 4226, AUSTRALIA
Country
Australia
Secondary sponsor category [1] 293501 0
None
Name [1] 293501 0
Address [1] 293501 0
Country [1] 293501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296073 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 296073 0
Bond University
University Drive, Robina
Gold Coast, QLD 4226
Ethics committee country [1] 296073 0
Australia
Date submitted for ethics approval [1] 296073 0
Approval date [1] 296073 0
12/04/2016
Ethics approval number [1] 296073 0
15478

Summary
Brief summary
The nature of training and competition in the majority of popular sports dictates that debilitating injury is not uncommon when individuals engage in high musculoskeletal loading patterns and/or high impact collisions. A consequence of such injuries is that repair and remodelling of tissues often requires significant periods of limb immobilisation. It is during immobilisation that normal mechanical loading of skeletal muscle is significantly
reduced and muscle wasting (atrophy) ensues.
Disuse atrophy is a secondary complication that exacerbates the aetiology of injury and complicates the return to appropriate quality and quantity of training. Better understanding of the genetic bases of disuse muscle atrophy in athletes following abrupt cessation of regular training and competition may ultimately result in improved countermeasures to mitigate short term muscle wasting. Specific strategies such as individualised
nutrition and exercise rehabilitation to promote the prompt return of functional capacity may be entirely plausible with greater understanding of changes in inducible expression in skeletal muscle with shortterm immobilisation.
The primary aim of the proposed study is to determine changes in inducible gene expression in the early (3 d) and short term
(14 d) immobilisation period. The research question is novel and will have the capacity to inform sports medicine and exercise science in characterising individuals ‘at risk’
of rapid degeneration of muscle mass with disuse or those that may be “protected” from muscle loss with short term unloading.
It is hypothesised that 14 days of limb immobilisation will modulate expression of the transcriptome in skeletal muscle and generate a distinct genomic profile associated with the early time course of muscle atrophy in healthy, young men.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69470 0
A/Prof Vernon Coffey
Address 69470 0
Bond Institute of Health and Sport
2 Promethean Way
Robina, QLD, 4226
Country 69470 0
Australia
Phone 69470 0
+61755952162
Fax 69470 0
Email 69470 0
[email protected]
Contact person for public queries
Name 69471 0
Vernon Coffey
Address 69471 0
Bond Institute of Health and Sport
2 Promethean Way
Robina, QLD 4226
Country 69471 0
Australia
Phone 69471 0
+61755952162
Fax 69471 0
Email 69471 0
[email protected]
Contact person for scientific queries
Name 69472 0
Vernon Coffey
Address 69472 0
Bond Institute of Health and Sport
2 Promethean Way
Robina, QLD 4226
Country 69472 0
Australia
Phone 69472 0
+61755952162
Fax 69472 0
Email 69472 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
SourceTitleYear of PublicationDOI
EmbaseThe muscle proteome reflects changes in mitochondrial function, cellular stress and proteolysis after 14 days of unilateral lower limb immobilization in active young men.2022https://dx.doi.org/10.1371/journal.pone.0273925
N.B. These documents automatically identified may not have been verified by the study sponsor.