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Trial registered on ANZCTR


Registration number
ACTRN12617000058370
Ethics application status
Approved
Date submitted
9/01/2017
Date registered
11/01/2017
Date last updated
11/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of leg resistance training with blood-flow restriction on unrestricted exercising arms: A validation study
Scientific title
The effects of leg resistance training with blood-flow restriction on the muscle size of an unrestricted exercising arm compared with an inactive arm or both an active and inactive arm with traditional resistance leg exercise in healthy males aged 18-25 years.
Secondary ID [1] 284842 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older adult physical/functional performance 292235 0
Condition category
Condition code
Musculoskeletal 292548 292548 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 292572 292572 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a seven-week training program where participants train at the lab three days per week (twenty sessions; 45 minute duration each). Exercises performed are three sets of bicep curls (50% 1 RM) performed by the dominant arm followed by four sets of bilateral knee flexion and leg extension exercises (30% 1 RM). 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 by an exercise physiologist to ensure safety and adherence to the protocol.
Attendance is registered for all training sessions.
Intervention code [1] 289619 0
Treatment: Other
Intervention code [2] 289639 0
Rehabilitation
Comparator / control treatment
A training control group that performs an identical protocol to the intervention group without applied BFR.
Control group
Active

Outcomes
Primary outcome [1] 292424 0
Muscle cross-sectional area of the exercised arm - assessed via peripheral quantitative computed tomography (pQCT) scan at 50% Humerus length
Timepoint [1] 292424 0
Seven weeks following training commencement (20 sessions)
Primary outcome [2] 292425 0
Muscle strength of the exercised arm - assessed via 1-RM method for unilateral bicep curl exercise.
Timepoint [2] 292425 0
Seven weeks following training commencement (20 sessions)
Secondary outcome [1] 308909 0
Muscle cross-sectional area of the dominant leg - assessed via pQCT scan at 25% Femur length.
Timepoint [1] 308909 0
Seven weeks following training commencement (20 sessions)
Secondary outcome [2] 308911 0
Leg muscle strength - assessed via 1-RM method for bilateral leg extension and leg flexion exercises.
Timepoint [2] 308911 0
Seven weeks following training commencement (20 sessions)
Secondary outcome [3] 330691 0
Muscle cross-sectional area of the inactive arm - assessed via peripheral quantitative computed tomography (pQCT) scan at 50% Humerus length
Timepoint [3] 330691 0
7 weeks following training commencement (20 sessions)
Secondary outcome [4] 330692 0
Muscle strength of the inactive arm - assessed via 1-RM method for unilateral bicep curl exercise.
Timepoint [4] 330692 0
7 weeks following training commencement (20 sessions).

Eligibility
Key inclusion criteria
Young healthy males (18-25 years)
Minimum age
18 Years
Maximum age
25 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 that have performed regular resistance training in the last six months
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)
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
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
1/05/2016
Date of last data collection
Anticipated
Actual
5/07/2016
Sample size
Target
26
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289447 0
University
Name [1] 289447 0
Centre for Physical Activity and Nutrition research, School of Exercise and Nutrition Sciences, Deakin University
Country [1] 289447 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] 288139 0
Individual
Name [1] 288139 0
Anthony May
Address [1] 288139 0
Centre for Physical Activity and Nutrition research
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC, 3125
Country [1] 288139 0
Australia
Other collaborator category [1] 278013 0
Individual
Name [1] 278013 0
Aaron Russell
Address [1] 278013 0
Centre for Physical Activity and Nutrition research
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC, 3125
Country [1] 278013 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291205 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 291205 0
Ethics committee country [1] 291205 0
Australia
Date submitted for ethics approval [1] 291205 0
Approval date [1] 291205 0
20/01/2014
Ethics approval number [1] 291205 0
HEAG-H 2013-296

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

Contacts
Principal investigator
Name 49222 0
Dr Stuart Warmington
Address 49222 0
Deakin University, 221 Burwood Hwy, Burwood, VIC 3125
Country 49222 0
Australia
Phone 49222 0
+61 3 9251 7013
Fax 49222 0
Email 49222 0
stuart.warmington@deakin.edu.au
Contact person for public queries
Name 49223 0
Stuart Warmington
Address 49223 0
Deakin University, 221 Burwood Hwy, Burwood, VIC 3125
Country 49223 0
Australia
Phone 49223 0
+61 3 9251 7013
Fax 49223 0
Email 49223 0
stuart.warmington@deakin.edu.au
Contact person for scientific queries
Name 49224 0
Stuart Warmington
Address 49224 0
Deakin University, 221 Burwood Hwy, Burwood, VIC 3125
Country 49224 0
Australia
Phone 49224 0
+61 3 9251 7013
Fax 49224 0
Email 49224 0
stuart.warmington@deakin.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.