ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Skeletal muscle atrophy

Condition category

Condition code

Musculoskeletal

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]

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]

Changes in quadriceps muscle mass quantified by MRI and DEXA scans

Timepoint [1]

Baseline (Day 0), day 3 and day 14 measurements

Primary outcome [2]

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]

Day 0 and day 14

Secondary outcome [1]

Change in muscle strength as determined by isometric and isoinertial testing

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Education and Training

Address [1]

Department of Education and Training
GPO Box 9880
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Bond University

Address

14 University Drive
ROBINA QLD 4226, AUSTRALIA

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bond University Human Research Ethics Committee

Ethics committee address [1]

Bond University
University Drive, Robina
Gold Coast, QLD 4226

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/04/2016

Ethics approval number [1]

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

A/Prof Vernon Coffey

Address

Bond Institute of Health and Sport
2 Promethean Way
Robina, QLD, 4226

Country

Australia

Phone

+61755952162

Fax

vcoffey@bond.edu.au

Contact person for public queries

Name

Vernon Coffey

Address

Bond Institute of Health and Sport
2 Promethean Way
Robina, QLD 4226

Country

Australia

Phone

+61755952162

Fax

vcoffey@bond.edu.au

Contact person for scientific queries

Name

Vernon Coffey

Address

Bond Institute of Health and Sport
2 Promethean Way
Robina, QLD 4226

Country

Australia

Phone

+61755952162

Fax

vcoffey@bond.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

Source	Title	Year of Publication	DOI
Embase	The muscle proteome reflects changes in mitochondrial function, cellular stress and proteolysis after 14 days of unilateral lower limb immobilization in active young men.	2022	https://dx.doi.org/10.1371/journal.pone.0273925

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically