Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000182695
Ethics application status
Approved
Date submitted
3/02/2023
Date registered
21/02/2023
Date last updated
25/08/2024
Date data sharing statement initially provided
21/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the impact of walking with inflatable cuffs on fitness and function of older people
Scientific title
Assessing the impact of walking with inflatable cuffs on fitness and function of older people
Secondary ID [1] 308911 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 328911 0
Falls 329107 0
Condition category
Condition code
Musculoskeletal 325901 325901 0 0
Other muscular and skeletal disorders
Injuries and Accidents 326029 326029 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a 12-week supervised walking program for older adults (aged >60 yrs). The walking will be performed while wearing inflatable cuffs on the legs to cause moderate blood flow restriction (BFR).

This will be a two-armed RCT. Older people will be recruited to undertake a 12-week walking exercise intervention. Participants will also be followed up at 6 and 12 months after the exercise intervention has concluded. Participants will be randomly allocated to one of two arms for the duration of the study:

ARM 1 - Traditional walking (TW):
Participants fill follow a walking program for 12 weeks. This will be supervised by an Exercise Scientist with >4 years experience in prescribing and implementing exercise programs, and will take place around the campus of Murdoch University (Perth, Australia). The walking will be performed 3 times per week for 50 minutes each session, and will be of a moderate intensity (approximately 3-6 km/hr), totalling 150 minutes of physical activity (i.e. following the standard guidelines for cardiovascular exercise from the American College of Sports Medicine).

ARM 2 - Walking with blood flow restriction (BFRW):
The exercise interventions in this group will be similar to ARM 1, in that participants will perform a 12-week supervised walking intervention at moderate speed. This walking exercise will be completed whilst wearing inflatable BFR cuffs on their upper thighs (inflated to sub-occlusive pressures) for portions of each exercise session. These cuffs are 10cm wide, and similar to a cuff that would be used to assess blood pressure with a GP. They simply wrap around the legs and velcro to themselves to stay in place. The cuffs are inflated with a rubber bulb and pressure gauge, that are then detached to ensure constant pressure during exercise (i.e. are not monitored for pressure changes during exercise). This group will perform 3 sessions per week of 25 minutes (total 75 minutes per week), with the BFR cuffs inflated for 20 minutes of the total 25 minutes. The actual pressure applied will be individualised for each participant as 60% of the pressure required to occlude blood flow at rest (i.e. the arterial occlusion pressure; AOP). The AOP will be determined individually for each participant in their initial training session via gradual cuff inflation whilst auscultating the posterior tibial artery with doppler ultrasound, to determine the pressure required for complete occlusion.

Exercise adherence will be assessed for all participants in the research by an Exercise Scientist who is running the training sessions. The total number of sessions completed will be recorded to indicate adherence to the program and the training dose experienced.
Intervention code [1] 325355 0
Lifestyle
Comparator / control treatment
ARM 1 - performing similar training as ARM 2, but without BFR applied during exercise, and for 150 mins per week (compared to 75 mins per week in ARM 2)
Control group
Active

Outcomes
Primary outcome [1] 333731 0
Functional ability - measured via the timed up-&-go, using a handheld stopwatch.
Timepoint [1] 333731 0
Baseline, mid-point (after 6 weeks of training), post-intervention (after 12 weeks of training; primary time point), and at 6 and 12 months after training cessation (secondary time points).
Primary outcome [2] 333732 0
Functional ability - measured via the timed sit-to-stand, using a handheld stopwatch.
Timepoint [2] 333732 0
Baseline, mid-point (after 6 weeks of training), post-intervention (after 12 weeks of training; primary time point), and at 6 and 12 months after training cessation (secondary time points).
Primary outcome [3] 333733 0
Functional ability - measured via the 6-min walk
Timepoint [3] 333733 0
Baseline, mid-point (after 6 weeks of training), post-intervention (after 12 weeks of training; primary time point), and at 6 and 12 months after training cessation (secondary time points).
Secondary outcome [1] 418085 0
Knee extension torque production - measured via isokinetic dynamometry.
Timepoint [1] 418085 0
Baseline, mid-point (after 6 weeks of training), post-intervention (after 12 weeks of training; primary time point), and at 6 and 12 months after training cessation (secondary time points).
Secondary outcome [2] 418086 0
Functional ability - measured via the maximal gait speed
Timepoint [2] 418086 0
Baseline, mid-point (after 6 weeks of training), post-intervention (after 12 weeks of training; primary time point), and at 6 and 12 months after training cessation (secondary time points).
Secondary outcome [3] 418087 0
Functional ability - measured via the 4-square step test
Timepoint [3] 418087 0
Baseline, mid-point (after 6 weeks of training), post-intervention (after 12 weeks of training; primary time point), and at 6 and 12 months after training cessation (secondary time points).
Secondary outcome [4] 418088 0
Muscle architecture - measured via muscle ultrasound (muscle thickness)
Timepoint [4] 418088 0
Baseline, mid-point (after 6 weeks of training), post-intervention (after 12 weeks of training; primary time point), and at 6 and 12 months after training cessation (secondary time points).
Secondary outcome [5] 418089 0
Cognitive function - measured via Cogstate testing battery
Timepoint [5] 418089 0
Baseline, post-intervention (after 12 weeks of training; primary time point), and at 6 and 12 months after training cessation (secondary time points).
Secondary outcome [6] 418090 0
Perceived exertion Likert-type scales
Timepoint [6] 418090 0
During training sessions across the 12-week program
Secondary outcome [7] 418091 0
Levels of enjoyment via the Physical Activity Enjoyment scale.
Timepoint [7] 418091 0
Baseline, post-intervention (after 12 weeks of training; primary time point), and at 6 and 12 months after training cessation (secondary time points).
Secondary outcome [8] 418092 0
Perceived fatigue via 100mm visual analogue scales.
Timepoint [8] 418092 0
During training sessions across the 12-week program (measured after training sessions conclude)
Secondary outcome [9] 418093 0
Perceived muscle soreness will be assessed via Likert scales.
Timepoint [9] 418093 0
During training sessions across the 12-week program (measured after training sessions conclude)
Secondary outcome [10] 418100 0
Gait characteristics during walking - measured via inertial measurement units
Timepoint [10] 418100 0
During training sessions across the 12-week program (measuring continuously during training sessions)

Eligibility
Key inclusion criteria
- Healthy older adult (over 60 yrs)
- Not currently engaged in resistance training, and have not undertaken resistance training in the previous 6 months
- Strength-to-weight ratio (knee extensor force divided by body mass) below 1.71 Nm·kg-1 for males and 1.34 Nm·kg-1 for females
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Body mass index >30 kg·m-2
- Currently engaging in structured exercise training
- Uncontrolled hypertension, neuromuscular disease, terminal disease, myocardial infarction in the past 6 months, unstable cardiovascular disease or a fracture within the last 6 months
- Those unable to satisfy the vigorous exercise requirements of the Adult Pre-exercise Screening System tool
- 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)
Computer-generated randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
46 participants will be required to complete the intervention. This sample was calculated from a priori power analysis to detect differences (power of 0.9, a of 0.05) in the timed up-and-go test for the interventions planned. Data will be assessed via 2-way analysis of variance, with between (i.e. intervention arms) and within (i.e. time points) group factors. Effect size statistics will also be calculated to determine the magnitude of differences observed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/03/2023
Actual
1/05/2023
Date of last participant enrolment
Anticipated
16/09/2024
Actual
Date of last data collection
Anticipated
29/11/2025
Actual
Sample size
Target
46
Accrual to date
43
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 313121 0
Government body
Name [1] 313121 0
National Health and Medical Research Council
Country [1] 313121 0
Australia
Primary sponsor type
Individual
Name
Dr Brendan Scott
Address
Discipline of Exercise Science
School of Allied Health
Murdoch University
90 South Street,
Murdoch 6150
WA
Country
Australia
Secondary sponsor category [1] 314821 0
Individual
Name [1] 314821 0
A/Prof Jeremiah Peiffer
Address [1] 314821 0
Office of Graduate Studies,
Murdoch University
90 South Street,
Murdoch 6150
WA
Country [1] 314821 0
Australia
Secondary sponsor category [2] 314822 0
Individual
Name [2] 314822 0
Prof Keith Hill
Address [2] 314822 0
Rehabilitation Ageing and Independent Living (RAIL) Research Centre
School of Primary and Allied Health Care,
Peninsula Campus,
Monash University,
McMahons Road, Frankston, 3199, VIC
Country [2] 314822 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312367 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 312367 0
Ethics committee country [1] 312367 0
Australia
Date submitted for ethics approval [1] 312367 0
09/02/2023
Approval date [1] 312367 0
23/02/2023
Ethics approval number [1] 312367 0

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

Contacts
Principal investigator
Name 124406 0
Dr Brendan Scott
Address 124406 0
Discipline of Exercise Science
School of Allied Health
Murdoch University
90 South Street,
Murdoch 6150
WA
Country 124406 0
Australia
Phone 124406 0
+61 8 9360 6575
Fax 124406 0
Email 124406 0
[email protected]
Contact person for public queries
Name 124407 0
Brendan Scott
Address 124407 0
Discipline of Exercise Science
School of Allied Health
Murdoch University
90 South Street,
Murdoch 6150
WA
Country 124407 0
Australia
Phone 124407 0
+61 8 9360 6575
Fax 124407 0
Email 124407 0
[email protected]
Contact person for scientific queries
Name 124408 0
Brendan Scott
Address 124408 0
Discipline of Exercise Science
School of Allied Health
Murdoch University
90 South Street,
Murdoch 6150
WA
Country 124408 0
Australia
Phone 124408 0
+61 8 9360 6575
Fax 124408 0
Email 124408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.