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Trial registered on ANZCTR


Registration number
ACTRN12614000649617
Ethics application status
Approved
Date submitted
12/06/2014
Date registered
20/06/2014
Date last updated
6/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the Effect of Blood Flow Restriction Walking Training on Measures of Physical Function
Scientific title
In male and female older adults aged 60 to 80 years is 6 w x 4d/w blood flow restriction walking exercise more effective in improving performance in functional physical assessments compared with unrestricted walking exercise (placebo).
Secondary ID [1] 284787 0
HEAG-H 60_2014
Universal Trial Number (UTN)
U1111-1157-9757
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older adult physical/functional performance 292162 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292499 292499 0 0
Other physical medicine / rehabilitation
Musculoskeletal 292500 292500 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Blood flow restriction (BFR) exercise
Training period: 6 weeks
Training frequency: 4 days per week
Exercise mode: Walking
Training intensity/duration: 4 km/h, 10 min

BFR is initiated via pneumatic cuffs placed around the limb proximal to the exercising muscle/muscle group that produce an individualized restriction to limb blood flow, but NOT total occlusion to flow. No adverse reactions are noted and participants are supervised/monitored throughout all training sessions to ensure safety and adherence to the protocol.
Intervention code [1] 289577 0
Treatment: Other
Intervention code [2] 289578 0
Rehabilitation
Comparator / control treatment
Intervention: Active/Unrestricted exercise
Training period: 6 weeks
Training frequency: 4 days per week
Exercise mode: Walking
Training intensity/duration: 4 km/h, 10 min

The Active/Unrestricted group will undertake exercise without a restriction to limb blood flow, and without application of the BFR cuffs so as to represent the normal expected walking training stimulus.
Control group
Active

Outcomes
Primary outcome [1] 292359 0
Performance on 6 min Walk Test
Timepoint [1] 292359 0
Baseline, 3 w and 6 w
Primary outcome [2] 292360 0
Performance on Timed Up and Go test
Timepoint [2] 292360 0
Baseline, 3 w and 6 w
Primary outcome [3] 292361 0
Performance on 30 s Sit to Stand test
Timepoint [3] 292361 0
Baseline, 3 w and 6 w
Secondary outcome [1] 308767 0
Performance on Queens College Step Test
Timepoint [1] 308767 0
Baseline, 3 w and 6 w

Eligibility
Key inclusion criteria
Age: 60-80 years
Weekly Physical Activity: <150 min
Minimum age
60 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed cardiovascular disease/uncontrolled hypertension
Smokers
Weekly Physical Activity: >150 min
Obesity

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)
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289403 0
University
Name [1] 289403 0
Centre for Physical Activity and Nutrition research
School of Exercise and Nutrition Sciences
Deakin University
Address [1] 289403 0
221 Burwood Highway
Burwood, VIC 3125
Country [1] 289403 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] 288085 0
Individual
Name [1] 288085 0
Matthew Clarkson
Address [1] 288085 0
Centre for Physical Activity and Nutrition research
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC, 3125
Country [1] 288085 0
Australia
Other collaborator category [1] 277998 0
Individual
Name [1] 277998 0
Louise Conway
Address [1] 277998 0
Clinical Exercise Learning Centre
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC, 3125
Country [1] 277998 0
Australia
Other collaborator category [2] 277999 0
Individual
Name [2] 277999 0
Anthony Barnett
Address [2] 277999 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC, 3125
Country [2] 277999 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291163 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 291163 0
Secretary HEAG-H
Pro Vice-Chancellor's Office
Faculty of Health
he3.018
221 Burwood Hwy
Burwood VIC 3125
Ethics committee country [1] 291163 0
Australia
Date submitted for ethics approval [1] 291163 0
Approval date [1] 291163 0
26/05/2014
Ethics approval number [1] 291163 0
HEAG-H 60_2014

Summary
Brief summary
This is a student project contributing to a Bachelor of Exercise and Sport Science (Honours) degree.
The purpose of this project is to investigate the application of blood flow restriction during exercise, and the training effects that result. There is a body of evidence that demonstrates benefits in muscle size and strength following low-intensity blood flow restriction training, equivalent to that of high-intensity exercise without the blood flow restriction. Studies have utilised several modes of exercise: walking, cycling, and resistance training and a large proportion of this research involves younger, apparently healthy participants, while research into its application in older adults is lacking.
It is likely that the benefits would be similar in older adults, and that this would directly improve performance in functional outcome measures representative of improved everyday function. Training with blood flow restriction cuffs at a low-intensity can produce these functional benefits while eliminating the intimidation, potential risk and negative stigma that surrounds high-intensity exercise in populations unlikely to adhere to it, such as older adults and frail adults.
This study will utilise functional outcome measures to gauge improvements in lower limb muscle strength following a 6-week blood flow restriction walking program.
Trial website
Trial related presentations / publications
Part of the data set for this trial was presented by a Deakin University Honours student in Oct 2014 as part of the requirements for students completing their Honours year of study.
In addition, part of the data set was used as the foundation for the students Honours thesis for submission for grading in Oct 2014.
Public notes

Contacts
Principal investigator
Name 49158 0
Dr Stuart Warmington
Address 49158 0
Centre for Physical Activity and Nutrition research
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country 49158 0
Australia
Phone 49158 0
+61392517013
Fax 49158 0
Email 49158 0
stuart.warmington@deakin.edu.au
Contact person for public queries
Name 49159 0
Mr Matthew Clarkson
Address 49159 0
Centre for Physical Activity and Nutrition research
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country 49159 0
Australia
Phone 49159 0
+61400225116
Fax 49159 0
Email 49159 0
mclarks@deakin.edu.au
Contact person for scientific queries
Name 49160 0
Mr Matthew Clarkson
Address 49160 0
Centre for Physical Activity and Nutrition research
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country 49160 0
Australia
Phone 49160 0
+61400225116
Fax 49160 0
Email 49160 0
mclarks@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary