Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000344493
Ethics application status
Approved
Date submitted
14/03/2016
Date registered
16/03/2016
Date last updated
29/11/2021
Date data sharing statement initially provided
27/09/2019
Date results information initially provided
27/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The LIFTMOR for Men trial: Is heavy resistance training or a machine-based isometric exercise program more effective at reducing risk of fracture in older men with reduced bone mass?
Scientific title
A randomised controlled trial to determine the effectiveness of heavy progressive resistance training versus high load machine-based isometric resistance training to reduce the risk of osteoporotic fracture in older men with low bone mass
Secondary ID [1] 288752 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
LIFTMOR (for Men): Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteopenia 297999 0
Osteoporosis 298022 0
Vertebral fracture 298023 0
Kyphosis 298024 0
Condition category
Condition code
Musculoskeletal 298152 298152 0 0
Osteoporosis
Injuries and Accidents 298179 298179 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a three-arm, semi-randomised controlled exercise intervention trial. Eligible volunteers will be randomly allocated to one of two eight month, twice-weekly, 30-minute exercise programs; either supervised heavy progressive resistance training and impact loading, or machined-based isometric resistance training using the bioDensity system.
Arm 1 – supervised heavy progressive resistance training and weight-bearing impact loading.
Three compound movement exercises (deadlift, overhead press, and squat) using olympic weights will be completed. For each exercise, 5 sets of 5 repetitions, corresponding to an intensity of 80-85 % of 1 repetition maximum will be performed. 5 sets of 5 repetitions of weight-bearing impact loading exercises (i.e. drop jumps) will also be performed, with height of the jump progressively increasing across the intervention period.
Arm 2 – supervised high-load isometric exercise using the bioDensity system.
A single set of four isometric exercises (chest press, leg press, core and arm pull, and vertical lift) will be performed according to bioDensity device specifications. For each exercise, one repetition of a self-initiated 75%-maximum contraction will be held for 5 seconds.
Sessions are supervised by a single qualified trainer (Bachelor of Exercise Science with Honours, Level 1 Sports Trainer, Certificate III in Fitness), a PhD candidate in the School of Allied Health Sciences.
Training diaries will be used to record participant attendance at exercise sessions, and the completion of each element of the training session. Compliance will be determined as the number of sessions attended as a percentage of total possible sessions.
Intervention code [1] 294188 0
Treatment: Other
Intervention code [2] 294208 0
Prevention
Comparator / control treatment
Arm 3 – the comparator will be a non-randomised sample of men, recruited independently but sex- and age-matched to the exercise arms. They will simply continue with their usual activities for 8 months, but will undergo the identical testing protocol at baseline and follow-up as the two randomised arms. Weekly email contact will be maintained to approximate investigator exposure and track alterations to habitual diet or physical activity levels over the 8 month period.

Diaries will be provided and all participants will be encouraged to record any changes to medication, medical conditions and general health.
Control group
Active

Outcomes
Primary outcome [1] 297662 0
Whole body bone mineral density determined by Dual-energy X-ray Absorptiometry.
Timepoint [1] 297662 0
All participants, pre (baseline) and post-intervention (8 months)
Primary outcome [2] 297686 0
Bilateral proximal femur (femoral neck, trochanter and total hip regions of interest) bone mineral density determined by Dual-energy X-ray Absorptiometry.
Timepoint [2] 297686 0
All participants, pre (baseline) and post-intervention (8 months).
Primary outcome [3] 297687 0
Lumbar spine (L2-L4) bone mineral density determined by Dual-energy X-ray Absorptiometry.
Timepoint [3] 297687 0
All participants, pre (baseline) and post-intervention (8 months).
Secondary outcome [1] 321742 0
Indices of bone strength of the skeletally non-dominant forearm determined from peripheral Quantitative Computed Tomography.
Timepoint [1] 321742 0
All participants, pre (baseline) and post-intervention (8 months).
Secondary outcome [2] 321743 0
Heel bone quality determined by Quantitative Ultrasonometry.
Timepoint [2] 321743 0
All participants, pre (baseline) and post-intervention (8 months).
Secondary outcome [3] 321744 0
Body composition (lean mass, fat mass, appendicular lean mass and percentage body fat) from whole body Dual-energy X-ray Absorptiometry.
Timepoint [3] 321744 0
All participants, pre (baseline) and post-intervention (8 months).
Secondary outcome [4] 321745 0
Muscle strength will be measured via handheld dynamometry using previously validated techniques (maximal isometric leg and thoracic extension muscle strength).
Timepoint [4] 321745 0
All participants, pre (baseline) and post-intervention (8 months).
Secondary outcome [5] 321746 0
Thoracic kyphosis will be determined using an inclinometer.
Timepoint [5] 321746 0
All participants, pre (baseline) and post-intervention (8 months).
Secondary outcome [6] 321747 0
Daily average calcium intake using the validated AusCal questionnaire.
Timepoint [6] 321747 0
All participants, pre (baseline) and post-intervention (8 months).
Secondary outcome [7] 321748 0
Safety (adverse events and injuries) from training diaries across the whole exercise intervention period.
Timepoint [7] 321748 0
Across the intervention period (8 months).
Secondary outcome [8] 321835 0
Quality of life using the validated World Health Organisation 'Quality of Life' questionnaire.
Timepoint [8] 321835 0
All participants, pre (baseline) and post-intervention (8 months).
Secondary outcome [9] 321836 0
Bone-specific physical activity level using the validated 'Bone-specific Physical Activity' (BPAQ) questionnaire.
Timepoint [9] 321836 0
All participants, pre (baseline) and post-intervention (8 months).
Secondary outcome [10] 321837 0
Indices of bone strength of the skeletally non-dominant leg determined from peripheral Quantitative Computed Tomography.
Timepoint [10] 321837 0
All participants, pre (baseline) and post intervention (8 months).
Secondary outcome [11] 321838 0
Muscle density of the skeletally non-dominant forearm determined from peripheral Quantitative Computed Tomography.
Timepoint [11] 321838 0
All participants, pre (baseline) and post-intervention (8 months).
Secondary outcome [12] 321839 0
Muscle density of the skeletally non-dominant leg determined from peripheral Quantitative Computed Tomography.
Timepoint [12] 321839 0
All participants, pre (baseline) and post-intervention (8 months).
Secondary outcome [13] 321840 0
Compliance from training diaries across the whole exercise intervention period.
Timepoint [13] 321840 0
Across the intervention period (8 months)
Secondary outcome [14] 321841 0
Physical function will be determined using previously validated techniques, forming a composite measure (timed up-and-go and five-times sit-to-stand).
Timepoint [14] 321841 0
All participants, pre (baseline) and post-intervention (8 months).

Eligibility
Key inclusion criteria
Men
Apparently healthy
With low bone mineral density (hip or spine BMD T-score less than or equal to -1.0)
Not currently or recently participating in regular resistance training or impact-type exercise
Minimum age
45 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Current participation in resistance training or exercise with an impact-loading component
Uncontrolled cardiovascular disease/respiratory conditions
Neurological conditions which might limit an individual’s ability to perform resistance training
Malignancy
Hernia
Medications know to adversely affect musculoskeletal health such as corticosteroids, anti-convulsants
Medical conditions known to effect musculoskeletal health such as hyperparathyroidism, Paget’s disease, diabetes

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Block randomisation to exercise will occur after participants are stratified by the presence or absence of medications for osteoporosis. The allocation sequence will be generated by a person independent of the trial and filed in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generated by computer program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Intervention assignment parallel
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2016
Actual
1/05/2016
Date of last participant enrolment
Anticipated
1/06/2018
Actual
30/07/2018
Date of last data collection
Anticipated
1/04/2019
Actual
15/04/2019
Sample size
Target
150
Accrual to date
Final
93
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 293108 0
Charities/Societies/Foundations
Name [1] 293108 0
Osteoporosis Australia Equipment award (bioDensity device supplied and installed by Performance Health Systems)
Country [1] 293108 0
Australia
Funding source category [2] 293132 0
Commercial sector/Industry
Name [2] 293132 0
Performance Health Systems
Country [2] 293132 0
United States of America
Funding source category [3] 295685 0
Charities/Societies/Foundations
Name [3] 295685 0
Sports Medicine Australia
Country [3] 295685 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
School of Allied Health Sciences, Griffith University, Gold Coast campus
Parklands Drive, Southport, Gold Coast 4222, Queensland
Country
Australia
Secondary sponsor category [1] 291898 0
None
Name [1] 291898 0
Address [1] 291898 0
Country [1] 291898 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294609 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 294609 0
170 Kessels Road Nathan, QLD 4111
Ethics committee country [1] 294609 0
Australia
Date submitted for ethics approval [1] 294609 0
01/04/2014
Approval date [1] 294609 0
18/01/2016
Ethics approval number [1] 294609 0
AHS/07/14/HREC

Summary
Brief summary
Recent work undertaken at Griffith University (the LIFTMOR trial) has revealed that brief exposure to a bone-targeted heavy progressive resistance training program is both safe, and effective for enhancing musculoskeletal health and function, in postmenopausal women with low to very low bone mass. Similar claims have been made by the developers of the bioDensity system, designed around the premise that low volume machine-based isometric resistance training produces beneficial effects on balance, physical function, muscle strength and bone mass. Whether dynamic or isometric resistance training will be more effective in middle-aged and older men with reduced bone mass at the hip and spine remains to be seen.
Trial website
www.liftmor.org
Trial related presentations / publications
Public notes
Registration for the study has been completed.

Contacts
Principal investigator
Name 63790 0
Prof Belinda Beck
Address 63790 0
School of Allied Health Sciences
Gold Coast campus
Griffith University
Parklands Drive
Southport, Gold Coast,
Queensland, 4222
Country 63790 0
Australia
Phone 63790 0
+61 7 5552 8793
Fax 63790 0
+61 7 5552 8674
Email 63790 0
[email protected]
Contact person for public queries
Name 63791 0
Prof Belinda Beck
Address 63791 0
School of Allied Health Sciences
Gold Coast campus
Griffith University
Parklands Drive
Southport, Gold Coast,
Queensland, 4222
Country 63791 0
Australia
Phone 63791 0
+61 7 5552 8793
Fax 63791 0
+61 7 5552 8674
Email 63791 0
[email protected]
Contact person for scientific queries
Name 63792 0
Prof Belinda Beck
Address 63792 0
School of Allied Health Sciences
Gold Coast campus
Griffith University
Parklands Drive
Southport, Gold Coast,
Queensland, 4222
Country 63792 0
Australia
Phone 63792 0
+61 7 5552 8793
Fax 63792 0
+61 7 5552 8674
Email 63792 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5068Study protocolHarding AT, Weeks BK, Watson SL, et alThe LIFTMOR-M (Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation for Men) trial: protocol for a semirandomised controlled trial of supervised targeted exercise to reduce risk of osteoporotic fracture in older men with low bone massBMJ Open 2017;7:e014951. doi: 10.1136/bmjopen-2016-014951https://bmjopen.bmj.com/content/7/6/e014951 



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo Harding, A. T., Weeks, B. K., Weis, L. J., Lambert... [More Details]
Study results articleYes Harding, A. T., Weeks, B. K., Lambert, C., Watson,... [More Details]
Study results articleYes Harding, A. T., Weeks, B. K., Lambert, C., Watson,... [More Details]
Study results articleYes Harding, A. T., Weeks, B. K., Lambert, C., Watson,... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Comparison of Bone-Targeted Exercise Strategies to Reduce Fracture Risk in Middle-Aged and Older Men with Osteopenia and Osteoporosis: LIFTMOR-M Semi-Randomized Controlled Trial.2020https://dx.doi.org/10.1002/jbmr.4008
EmbaseExploring thoracic kyphosis and incident fracture from vertebral morphology with high-intensity exercise in middle-aged and older men with osteopenia and osteoporosis: a secondary analysis of the LIFTMOR-M trial.2021https://dx.doi.org/10.1007/s00198-020-05583-x
EmbaseEffects of supervised high-intensity resistance and impact training or machine-based isometric training on regional bone geometry and strength in middle-aged and older men with low bone mass: The LIFTMOR-M semi-randomised controlled trial.2020https://dx.doi.org/10.1016/j.bone.2020.115362
N.B. These documents automatically identified may not have been verified by the study sponsor.