Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000475448
Ethics application status
Approved
Date submitted
5/04/2016
Date registered
12/04/2016
Date last updated
19/06/2019
Date data sharing statement initially provided
19/06/2019
Date results provided
19/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
High intensity progressive resistance training for postmenopausal women with low to very low bone mass: The LIFTMOR trial
Scientific title
A randomized controlled trial to determine the effectiveness of high intensity progressive resistance training for postmenopausal women with low to very low bone mass
Secondary ID [1] 288871 0
None
Universal Trial Number (UTN)
Trial acronym
LIFTMOR - Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 298163 0
Falls prevention 298164 0
Kyphosis 298165 0
Height loss 298301 0
Condition category
Condition code
Musculoskeletal 298329 298329 0 0
Osteoporosis
Injuries and Accidents 298404 298404 0 0
Fractures
Physical Medicine / Rehabilitation 298427 298427 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention arm consists of a high intensity progressive resistance training program. Participants attend two 30-minute exercise sessions per week. Each sessions is conducted in groups of up to 6 participants and supervised by either a physiotherapist or exercise physiologist. The high intensity exercise program consists of four compound exercises (deadlift, overhead press, jumping chin ups and back squat) for 5 sets of 5 repetitions (>85% 1 repetition maximum). Compliance and weight lifted is monitored via training manuals which each participants completes at the end of each session.
Intervention code [1] 294331 0
Rehabilitation
Intervention code [2] 294418 0
Treatment: Other
Comparator / control treatment
A low load, home-based unsupervised exercise program will serve as a positive control. Controls will undertake two 30-minute sessions per week for a period of 8-months. Light resistance exercises such as sit to stands, single leg balance, lunges and forward raise will be performed with 1-3 kg dumbbells, 3 sets of 10-15 repetitions along with balance training.
Control group
Active

Outcomes
Primary outcome [1] 297802 0
Proximal femur bone mineral density determined by Dual-energy X-ray Absorptiometry.
Timepoint [1] 297802 0
All participants, at baseline and follow-up (8 months)
Primary outcome [2] 297805 0
Lumbar spine bone mineral density determined by Dual-energy X-ray Absorptiometry.
Timepoint [2] 297805 0
All participants, at baseline and follow-up (8 months)
Secondary outcome [1] 322284 0
Whole body lean mass as determined by Dual-energy X-ray Absorptiometry.
Timepoint [1] 322284 0
All participants, at baseline and follow-up (8 months)
Secondary outcome [2] 322290 0
Performance indices of falls risk will be examined by timed up and go test, functional reach test, five times sit to stand, back extensor strength, leg extensor strength and vertical jump
Timepoint [2] 322290 0
All participants, at baseline and follow-up (8 months)
Secondary outcome [3] 322505 0
Kyphosis measured using inclinometer
Timepoint [3] 322505 0
All participants, at baseline and follow-up (8 months)
Secondary outcome [4] 322606 0
Height measured using a stadiometer
Timepoint [4] 322606 0
All participants, at baseline and follow-up (8 months)
Secondary outcome [5] 322607 0
Whole body fat mass as determined by Dual-energy X-ray Absorptiometry.
Timepoint [5] 322607 0
All participants, at baseline and follow-up (8 months)

Eligibility
Key inclusion criteria
Postmenopausal women with low bone mass (T-score < -1.0)
Minimum age
60 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Musculoskeletal or medical conditions affecting the ability to perform exercise, medications or medical conditions known to effect bone health, cancer, recent radiation exposure or fracture and current engagement in resistance training

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator by computer program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Block randomisation based on presence or absence of osteoporosis medications
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be undertaken using SPSS statistical software (Version 21; SPSS Inc., Chicago, IL). Descriptive statistics will be generated for subject characteristics, biometrics, and all dependent measures. A per protocol and intention to treat analyses will be adopted with repeated measures ANOVA to test our hypotheses. All statistical analyses will be conducted using a P-value of 0.05 to determine statistical significance.

Based on a previous similar high intensity resistance training intervention trial in postmenopausal women, to achieve 80% power to detect between-group differences of 2.7% with a standard deviation of 4.5% for femoral neck BMD and 3.5% with a standard deviation of 3.6% for lumbar spine, a total of 68 and 52 participants are required. We recruited one-hundred and one postmenopausal women to account for 20% drop out and account for an accelerated bone loss in the control group in the aforementioned study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/05/2014
Date of last participant enrolment
Anticipated
Actual
5/11/2015
Date of last data collection
Anticipated
Actual
24/08/2016
Sample size
Target
101
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 293223 0
Charities/Societies/Foundations
Name [1] 293223 0
Sports Medicine Australia
Country [1] 293223 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] 292075 0
None
Name [1] 292075 0
Address [1] 292075 0
Country [1] 292075 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294703 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 294703 0
Ethics committee country [1] 294703 0
Australia
Date submitted for ethics approval [1] 294703 0
27/02/2014
Approval date [1] 294703 0
01/04/2014
Ethics approval number [1] 294703 0
AHS/07/14/HREC

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

Contacts
Principal investigator
Name 53230 0
Prof Belinda Beck
Address 53230 0
Menzies Health Institute QLD
School of Allied Health Sciences
Gold Coast campus
Griffith University
Parklands Drive
Southport, Gold Coast,
Queensland, 4222
Country 53230 0
Australia
Phone 53230 0
+61 7 5552 8793
Fax 53230 0
Email 53230 0
[email protected]
Contact person for public queries
Name 53231 0
Belinda Beck
Address 53231 0
Menzies Health Institute QLD
School of Allied Health Sciences
Gold Coast campus
Griffith University
Parklands Drive
Southport, Gold Coast,
Queensland, 4222
Country 53231 0
Australia
Phone 53231 0
+61 7 5552 8793
Fax 53231 0
Email 53231 0
[email protected]
Contact person for scientific queries
Name 53232 0
Belinda Beck
Address 53232 0
Menzies Health Institute QLD
School of Allied Health Sciences
Gold Coast campus
Griffith University
Parklands Drive
Southport, Gold Coast,
Queensland, 4222
Country 53232 0
Australia
Phone 53232 0
+61 7 5552 8793
Fax 53232 0
Email 53232 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
SourceTitleYear of PublicationDOI
Dimensions AIThe 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 mass2017https://doi.org/10.1136/bmjopen-2016-014951
EmbaseHigh-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial.2018https://dx.doi.org/10.1002/jbmr.3284
EmbaseHigh-intensity exercise did not cause vertebral fractures and improves thoracic kyphosis in postmenopausal women with low to very low bone mass: the LIFTMOR trial.2019https://dx.doi.org/10.1007/s00198-018-04829-z
N.B. These documents automatically identified may not have been verified by the study sponsor.