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
ACTRN12615000949583
Ethics application status
Approved
Date submitted
31/08/2015
Date registered
10/09/2015
Date last updated
11/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The intramuscular and circulatory responses to various resistance training programs in healthy males
Scientific title
The effects of resistance training with blood-flow restriction training on intramuscular and systemic expression and muscle size and strength compared with heavy-load training, and an untrained control group in healthy males aged 18-30 years.
Secondary ID [1] 287384 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Younger adult physical/functional performance 296077 0
Musculoskeletal rehabilitation 296078 0
Condition category
Condition code
Musculoskeletal 296340 296340 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 296341 296341 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention(s) are seven-week training programs where participants train at the lab three days per week for 45 min training sessions. Interventions will occur on an individual basis supervised by a trained exercise physiologist. There are three different interventions, of which participants will perform one only (random allocation).

Intervention 1: Blood-flow restriction (BFR)
Exercises performed are bicep curls (3 sets; 10 repetitions; 50% 1 RM) performed by the dominant arm followed by four sets of bilateral knee flexion and leg extension exercises (1 set x 30 reps, 3 sets x 15 reps; 30% 1 RM).
The rest period between bicep curl sets is 3 min. The rest period between leg extension and knee flexion sets is 30 sec.
The leg exercises are performed with pressurised cuffs applied to the most proximal portion of the upper legs to restrict blood-flow to the working muscles. These cuffs are inflated to a pressure equal to 60% of the pressure required to completely occlude blood-flow through the legs.
Participants are supervised/monitored throughout all training sessions to ensure safety and adherence to the protocol.

Intervention 2: High-intensity (HI)
Exercises: Dominant arm bicep curls (3 sets; 10 repetitions; 50% 1 RM), Knee flexion (4 sets; 8 repetitions; 80% 1 RM) and leg extension (4 sets; 8 repetitions; 80% 1 RM). No blood-flow restriction applied.
The rest period between bicep curl sets is 3 min. The rest period between leg extension and knee flexion sets is 2 min.
Intervention code [1] 292770 0
Treatment: Devices
Intervention code [2] 292771 0
Treatment: Other
Comparator / control treatment
Control 1: CON
A non-training control group.
Control group
Active

Outcomes
Primary outcome [1] 295992 0
Intramuscular markers of protein synthesis (mammalian target of rapamycin (mTOR), S6 Kinase 1 (S6K1)) and protein degradation (Forkhead box O (FoxO), Atrogin-1, MuRF-1).
Markers assessed via muscle biopsy taken from dominant quadriceps muscle.
Timepoint [1] 295992 0
Immediately prior to, immediately post, 2 hours post, and 24 hours post final training session,
Primary outcome [2] 295993 0
Circulatory markers of angiogenesis (vascular endothelial growth factor (VEGF), nitric oxide (NO)).
Timepoint [2] 295993 0
Immediately prior to, immediately post, 2 hours post, and 24 hours post final training session,
Secondary outcome [1] 317118 0
Muscle strength (1-RM).
Specifically, leg extensor strength via seated leg extension 1-RM test, and knee flexion strength via prone knee flexion 1-RM test.
Timepoint [1] 317118 0
2 days following 10th training session, and 3 days following final training session
Secondary outcome [2] 317119 0
Muscle size (cross-sectional area) measured via peripheral quantitative computed tomography (pQCT) scans.
Specific muscle assessed are: total mid-thigh CSA, mid-thigh quadriceps CSA, mid-thigh hamstrings CSA, total mid-arm CSA.
Timepoint [2] 317119 0
Within 1 week of final training session.

Eligibility
Key inclusion criteria
Male
18-30 years of age
Not regularly strength trained within six months of recruitment.
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those unable to satisfy the vigorous exercise requirements of the Adult Pre-exercise Screening System tool.
People with blood-clotting disorders
People that have performed regular resistance training in the last six months.
Female
People with diagnosed cardiovascular disease, uncontrolled hypertension, high resting blood pressure or heart rate.
People who cannot easily comfortably perform the exercise due to musculoskeletal injuries.
People in existing dependent or unequal relationships with project staff.

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)
Participants are grouped for baseline leg extension muscle strength then are randomly allocated via randomisation software to the intervention groups and the control group.
Allocation is not concealed.
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
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
31/08/2015
Actual
4/09/2015
Date of last participant enrolment
Anticipated
Actual
1/10/2016
Date of last data collection
Anticipated
Actual
10/12/2016
Sample size
Target
36
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291951 0
University
Name [1] 291951 0
School of Exercise and Nutrition Sciences, Deakin University
Country [1] 291951 0
Australia
Primary sponsor type
Individual
Name
Stuart Warmington
Address
Centre for Physical Activity and Nutrition research
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC, 3125
Country
Australia
Secondary sponsor category [1] 290618 0
Individual
Name [1] 290618 0
Aaron Russell
Address [1] 290618 0
Centre for Physical Activity and Nutrition research
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC, 3125
Country [1] 290618 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293446 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 293446 0
Ethics committee country [1] 293446 0
Australia
Date submitted for ethics approval [1] 293446 0
Approval date [1] 293446 0
13/11/2014
Ethics approval number [1] 293446 0
HEAG-H 2014-229

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

Contacts
Principal investigator
Name 59962 0
Dr Stuart Warmington
Address 59962 0
Deakin University
221 Burwood Hwy,
Burwood, VIC 3125
Country 59962 0
Australia
Phone 59962 0
+61 3 9251 7013
Fax 59962 0
Email 59962 0
[email protected]
Contact person for public queries
Name 59963 0
Stuart Warmington
Address 59963 0
Deakin University
221 Burwood Hwy,
Burwood, VIC 3125
Country 59963 0
Australia
Phone 59963 0
+61 3 9251 7013
Fax 59963 0
Email 59963 0
[email protected]
Contact person for scientific queries
Name 59964 0
Stuart Warmington
Address 59964 0
Deakin University
221 Burwood Hwy,
Burwood, VIC 3125
Country 59964 0
Australia
Phone 59964 0
+61 3 9251 7013
Fax 59964 0
Email 59964 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
No additional documents have been identified.