Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000585123
Ethics application status
Approved
Date submitted
15/03/2019
Date registered
16/04/2019
Date last updated
30/11/2023
Date data sharing statement initially provided
16/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Lifting light weights with blood flow restriction to improve muscular fitness and functional abilities in older people
Scientific title
Low-load resistance training with blood flow restriction: a novel approach to improve muscular fitness and functional abilities in older people
Secondary ID [1] 297721 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 312046 0
Age-related functional declines 312047 0
Condition category
Condition code
Musculoskeletal 310608 310608 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 310833 310833 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a two-armed RCT. Older people will be recruited to undertake a 12 week resistance training intervention, with the initial 4-weeks comprising low-load exercise (predominantly body-weight while participants learn exercise techniques) and the remaining 8 weeks including traditional moderate-load training (lifting weights equivalent to 8-12 repetition maximum). Participants will also be followed up at 4 weeks after the exercise intervention has concluded (i.e. at 16 weeks). Participants will be randomly allocated to one of two arms for the duration of the study:

ARM 1 - Traditional resistance training (RT):
During the initial 4-week phase of training, participants will lift light weights for lower-body-based exercises. This training phase will aim to teach appropriate technique for lower-body exercises (variations of squats, deadlifts, lunges and step-ups). Training will occur 3x per week at Murdoch University's exercise science laboratory, and will always be supervised directly by an accredited exercise physiologist with a PhD under review and 4+ yrs experience implementing exercise training for older adults.

In the following 8 weeks, participants will use the same exercises from the initial 4-week phase, but they will now lift heavier weights following current recommendations from the American College of Sports Medicine. During this phase, training will occur under the same conditions as the introductory phase (directly supervised at Murdoch University, 3x per week). It is anticipated that all training sessions will last 30-60 minutes throughout the study.

ARM 2 - Resistance training with blood flow restriction (RTBFR):
The exercise interventions in this group will be identical to ARM 1, with the exception that the introductory 4-week phase of training will be performed with thin inflatable cuffs applied to the top of the thighs, and inflated to a sub-occlusive pressure during all training sessions. 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 Accredited Exercise Physiologist who is running the training sessions. The total number of sessions completed, as well as the number of repetitions and weight lifted for each set, will be recorded to indicate adherence to the program and the training dose experienced.
Intervention code [1] 313962 0
Treatment: Other
Intervention code [2] 313963 0
Rehabilitation
Comparator / control treatment
ARM 1 - performing the same training as ARM 2, but without BFR applied during exercise..
Control group
Active

Outcomes
Primary outcome [1] 319461 0
Muscle strength of the exercised limbs - assessed via 1-RM method for the leg press exercise
Timepoint [1] 319461 0
Baseline, after first 4 weeks of training (primary time point), and at 8 and 12 weeks into the training program, and finally at 4 weeks after training cessation (secondary time points).
Primary outcome [2] 319463 0
Functional ability - measured via the timed up-&-go, using a handheld stopwatch.
Timepoint [2] 319463 0
Baseline, after first 4 weeks of training (primary time point), and at 8 and 12 weeks into the training program, and finally at 4 weeks after training cessation (secondary time points).
Primary outcome [3] 319670 0
Functional ability - measured via the timed sit-to-stand, using a handheld stopwatch.
Timepoint [3] 319670 0
Baseline, after first 4 weeks of training (primary time point), and at 8 and 12 weeks into the training program, and finally at 4 weeks after training cessation (secondary time points).
Secondary outcome [1] 368268 0
Whole body composition and muscle mass - measured via duel-energy X-ray absorptiometry.
Timepoint [1] 368268 0
Baseline, after first 4 weeks of training, and at 8 and 12 weeks into the training program, and finally at 4 weeks after training cessation.
Secondary outcome [2] 368269 0
Knee extension maximal torque - measured via isokinetic dynamometry.
Timepoint [2] 368269 0
Baseline, after first 4 weeks of training, and at 8 and 12 weeks into the training program, and finally at 4 weeks after training cessation.
Secondary outcome [3] 368271 0
Perceived exertion Likert-type scales.
Timepoint [3] 368271 0
During all training sessions across the 12-week program.
Secondary outcome [4] 368272 0
Levels of enjoyment via the Physical Activity Enjoyment scale.
Timepoint [4] 368272 0
Baseline, after first 4 weeks of training, and at 8 and 12 weeks into the training program, and finally at 4 weeks after training cessation.
Secondary outcome [5] 369108 0
PRIMARY OUTCOME: Functional ability - measured via the maximal gait speed
Timepoint [5] 369108 0
Baseline, after first 4 weeks of training (primary time point), and at 8 and 12 weeks into the training program, and finally at 4 weeks after training cessation (secondary time points).
Secondary outcome [6] 369109 0
PRIMARY OUTCOME: Functional ability - measured via the 6-min walk
Timepoint [6] 369109 0
Baseline, after first 4 weeks of training (primary time point), and at 8 and 12 weeks into the training program, and finally at 4 weeks after training cessation (secondary time points).
Secondary outcome [7] 369110 0
PRIMARY OUTCOME: Functional ability - measured via the 4-square step test
Timepoint [7] 369110 0
Baseline, after first 4 weeks of training (primary time point), and at 8 and 12 weeks into the training program, and finally at 4 weeks after training cessation (secondary time points).
Secondary outcome [8] 369111 0
Knee extension rate of force development - measured via isokinetic dynamometry.
Timepoint [8] 369111 0
Baseline, after first 4 weeks of training, and at 8 and 12 weeks into the training program, and finally at 4 weeks after training cessation.
Secondary outcome [9] 369113 0
Perceived fatigue via 100mm visual analogue scales.
Timepoint [9] 369113 0
During all training sessions across the 12-week program.
Secondary outcome [10] 369114 0
Perceived muscle soreness will be assessed via Likert scales.
Timepoint [10] 369114 0
During all training sessions across the 12-week program.

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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
22 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 strength changes and performance 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
15/07/2019
Actual
15/07/2019
Date of last participant enrolment
Anticipated
17/06/2024
Actual
Date of last data collection
Anticipated
23/09/2024
Actual
Sample size
Target
22
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302250 0
Government body
Name [1] 302250 0
WA Department of Health
Country [1] 302250 0
Australia
Primary sponsor type
Individual
Name
Dr. Brendan Scott
Address
Discipline of Exercise Science
College of Science, Health, Engineering and Education
Murdoch University
90 South Street,
Murdoch 6150
WA
Country
Australia
Secondary sponsor category [1] 302108 0
Individual
Name [1] 302108 0
A/Prof. Jeremiah Peiffer
Address [1] 302108 0
Discipline of Exercise Science
College of Science, Health, Engineering and Education
Murdoch University
90 South Street,
Murdoch 6150
WA
Country [1] 302108 0
Australia
Secondary sponsor category [2] 302111 0
Individual
Name [2] 302111 0
Mr. Kieran Marston
Address [2] 302111 0
Discipline of Exercise Science
College of Science, Health, Engineering and Education
Murdoch University
90 South Street,
Murdoch 6150
WA
Country [2] 302111 0
Australia
Secondary sponsor category [3] 302113 0
Individual
Name [3] 302113 0
Prof. Keith Hill
Address [3] 302113 0
Faculty of Health Sciences
Curtin University
Kent Street, Bentley, Perth
Western Australia, 6102
Country [3] 302113 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302926 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 302926 0
Ethics committee country [1] 302926 0
Australia
Date submitted for ethics approval [1] 302926 0
21/03/2019
Approval date [1] 302926 0
15/05/2019
Ethics approval number [1] 302926 0
2019/036

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

Contacts
Principal investigator
Name 91870 0
Dr Brendan Scott
Address 91870 0
Discipline of Exercise Science
College of Science, Health, Engineering and Education
Murdoch University
90 South Street,
Murdoch 6150
WA
Country 91870 0
Australia
Phone 91870 0
+61 8 9360 6575
Fax 91870 0
Email 91870 0
[email protected]
Contact person for public queries
Name 91871 0
Brendan Scott
Address 91871 0
Discipline of Exercise Science
College of Science, Health, Engineering and Education
Murdoch University
90 South Street,
Murdoch 6150
WA
Country 91871 0
Australia
Phone 91871 0
+61 8 9360 6575
Fax 91871 0
Email 91871 0
[email protected]
Contact person for scientific queries
Name 91872 0
Brendan Scott
Address 91872 0
Discipline of Exercise Science
College of Science, Health, Engineering and Education
Murdoch University
90 South Street,
Murdoch 6150
WA
Country 91872 0
Australia
Phone 91872 0
+61 8 9360 6575
Fax 91872 0
Email 91872 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
In order to ensure complete anonymity for participants.


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.