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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]

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

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Musculoskeletal

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]

Treatment: Other

Intervention code [2]

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]

Performance on 6 min Walk Test

Timepoint [1]

Baseline, 3 w and 6 w

Primary outcome [2]

Performance on Timed Up and Go test

Timepoint [2]

Baseline, 3 w and 6 w

Primary outcome [3]

Performance on 30 s Sit to Stand test

Timepoint [3]

Baseline, 3 w and 6 w

Secondary outcome [1]

Performance on Queens College Step Test

Timepoint [1]

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

Sex

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

23/06/2014

Actual

1/07/2014

Date of last participant enrolment

Anticipated

Actual

24/12/2014

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]

University

Name [1]

Centre for Physical Activity and Nutrition research
School of Exercise and Nutrition Sciences
Deakin University

Address [1]

221 Burwood Highway
Burwood, VIC 3125

Country [1]

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]

Individual

Name [1]

Matthew Clarkson

Address [1]

Centre for Physical Activity and Nutrition research
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC, 3125

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Louise Conway

Address [1]

Clinical Exercise Learning Centre
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC, 3125

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Anthony Barnett

Address [2]

School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC, 3125

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee

Ethics committee address [1]

Secretary HEAG-H
Pro Vice-Chancellor's Office
Faculty of Health
he3.018
221 Burwood Hwy
Burwood VIC 3125

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

26/05/2014

Ethics approval number [1]

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

Attachments [1]

/AnzctrAttachments/366525-Plain Language Statement and Consent.docx

Attachments [2]

/AnzctrAttachments/366525-BFR Walking Fliers_A4.docx

Attachments [3]

/AnzctrAttachments/366525-60_2014_APP_Stuart Warmington.pdf

Contacts

Principal investigator

Name

Dr 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

Phone

+61392517013

Fax

stuart.warmington@deakin.edu.au

Contact person for public queries

Name

Matthew Clarkson

Address

Centre for Physical Activity and Nutrition research
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC 3125

Country

Australia

Phone

+61400225116

Fax

mclarks@deakin.edu.au

Contact person for scientific queries

Name

Matthew Clarkson

Address

Centre for Physical Activity and Nutrition research
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood, VIC 3125

Country

Australia

Phone

+61400225116

Fax

mclarks@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.

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