Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001775101
Ethics application status
Approved
Date submitted
3/12/2019
Date registered
13/12/2019
Date last updated
13/12/2019
Date data sharing statement initially provided
13/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Novel exercise to maintain bone strength in postmenopausal women undergoing weight loss: The HALTMOR Trial
Scientific title
The HALTMOR Trial: Home-based And Lifting Training for Maintenance of Osteo Reserves. A novel exercise to maintain bone strength in postmenopausal women undergoing weight loss.
Secondary ID [1] 299209 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
HALTMOR: Home-based And Lifting Training for Maintenance of Osteo Reserves
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 314321 0
Osteopenia 314322 0
Obesity 314323 0
Overweight 314324 0
Condition category
Condition code
Musculoskeletal 312671 312671 0 0
Osteoporosis
Musculoskeletal 312672 312672 0 0
Osteoarthritis
Diet and Nutrition 312673 312673 0 0
Obesity
Physical Medicine / Rehabilitation 313814 313814 0 0
Other physical medicine / rehabilitation
Reproductive Health and Childbirth 313815 313815 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a two-arm, randomised controlled exercise intervention trial. Eligible volunteers will be randomly allocated to one of the two eight-month, twice-weekly, 30-minute exercise programs; either a supervised high-intensity progressive resistance training and impact loading group, or an unsupervised home-based low intensity resistance training and flexibility training group.

Arm 1 - Supervised high-intensity progressive resistance and impact training (HiRIT).

Sessions will be supervised by a qualified trainer in a group setting with a maximum trainer to participant ratio of 1:6. Three compound movement exercises using Olympic weights (deadlifts, squats, and presses), along with a weight-bearing impact loading exercise (drop jumps) as per the LIFTMOR protocol (Watson et al., Journal of Bone and Mineral Research, 2017). Five sets of five repetitions will be performed for each exercise and intensity will be progressed to maintain 80-85% 1 repetition maximum and when deemed safe and appropriate by the trainer. Participants will be afforded up to 3 minutes rest between sets.

Training diaries will be used to record participant attendance to training session and to track the weights lifted over the duration of the intervention. Compliance to the training programs will be determined by the number of sessions attended as a percentage of the total number of possible sessions.
Intervention code [1] 315509 0
Treatment: Other
Comparator / control treatment
Arm 2 - Unsupervised low intensity home-based exercise (LoHBE).

Sessions are unsupervised and consist of a 10-minute walking warm-up, followed by four stretches (neck, shoulder, side and leg), the neck and side stretches will be performed for 10 seconds each side 2 times while the shoulder and leg stretches will be performed for 60 seconds each side 2 times. The low-load resistance exercises (lunges, sit to stands, calf raises, standing forward raise, toe walks and shrugs), increase with the addition of hand weights (to a maximum of 3 kg) and will be progressed by 1 kg every 12 weeks and performed for 3 sets of 10-20 repetitions. Single leg balance will also be performed by each leg and the complexity will be increased every 6 weeks wither through increase in duration of hold by 10 seconds, an increase in working sets or progressing to eyes closed. The session will finish with a 5-minute walking warm-down. The warm-up and warm-down will be completed between the range of 11-13/20 on the Borg RPE scale. As the training program is home-based participant will be taught all exercises by a qualified trainer in the initial testing session and will be contacted via email monthly to ensure regular contact and adequate progression of the program.

Training diaries will be used to record participant completion of training sessions and to assist the participants to track the progressions of their training. Compliance to the training programs will be determined by the number of sessions completed as a percentage of the total number of possible sessions.
Control group
Active

Outcomes
Primary outcome [1] 321322 0
Proximal femur (femoral neck and total hip regions of interest) bone mineral density determined by Dual-energy X-ray Absorptiometery (DXA).
Timepoint [1] 321322 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Primary outcome [2] 322236 0
Lumbar spine bone mineral density determined by Dual-energy X-ray Absorptiometery (DXA).
Timepoint [2] 322236 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Primary outcome [3] 322237 0
Fat mass and percentage determined from whole body Dual-energy X-ray Absorptiometry (DXA).
Timepoint [3] 322237 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [1] 377818 0
Lean mass determined from whole body Dual-energy X-ray Absorptiometry (DXA) – Primary Outcome.
Timepoint [1] 377818 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [2] 377819 0
Indices of bone and muscle strength of the forearm determined by peripheral Quantitative Computed Tomography (pQCT).
Timepoint [2] 377819 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [3] 377820 0
Indices of bone and muscle strength of the leg determined by peripheral Quantitative Computed Tomography (pQCT).
Timepoint [3] 377820 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [4] 377821 0
Bone quality of the calcaneus determined by Quantitative Ultrasonometry (QUS).
Timepoint [4] 377821 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [5] 377822 0
Muscle strength of the back extensors will be determined through the use of hand-held dynamometry.
Timepoint [5] 377822 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [6] 377823 0
Muscle strength of the lower limbs will be determined through the use of dynamometry.
Timepoint [6] 377823 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [7] 377825 0
Balance will be determined through the validated functional reach test (FRT).
Timepoint [7] 377825 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [8] 377827 0
Calcium intake determined from validated questionnaire (AusCal)
Timepoint [8] 377827 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [9] 377828 0
Bone-specific physical activity determined from validated questionnaire (BPAQ).
Timepoint [9] 377828 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [10] 377829 0
Physical activity enjoyment determined from validated questionnaire (PACES).
Timepoint [10] 377829 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [11] 377831 0
Safety (adverse events and injuries) of the program through self reporting, training diary records and monitoring throughout the intervention period.
Timepoint [11] 377831 0
HiRIT = twice weekly for the 8 month duration of the intervention
LoHBE = monthly monitoring for the 8 month duration of the intervention
Secondary outcome [12] 377832 0
Compliance to the program through training diary records and monitoring throughout the intervention period.
Timepoint [12] 377832 0
HiRIT = twice weekly for the 8 month duration of the intervention
LoHBE = monthly monitoring for the 8 month duration of the intervention
Secondary outcome [13] 377958 0
Physical function will be determined through the use of the timed up and go (TUG) test
Timepoint [13] 377958 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [14] 377959 0
Physical function will be determined through the 5 time sit to stand (5 x STS) test.
Timepoint [14] 377959 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [15] 377960 0
Lower limb muscle power will be determined through the maximal vertical jump (VJ) test.
Timepoint [15] 377960 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [16] 377961 0
Joint-related pain and disability determined from the validated WOMAC questionnaire.
Timepoint [16] 377961 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [17] 377962 0
Joint-related pain and disability will be determined from the validated ICOAP questionnaire .
Timepoint [17] 377962 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [18] 377963 0
Weight will be measured using a mechanical beam scale.
Timepoint [18] 377963 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [19] 377964 0
Waist circumference will be measured with an anthropometric tape in accordance with NIH guidelines.
Timepoint [19] 377964 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)
Secondary outcome [20] 377965 0
Waist-to-hip ratio will be measured with an anthropometric tape in accordance with NIH guidelines.
Timepoint [20] 377965 0
T0 - Baseline (prior to 8 month exercise intervention)
T8 - Follow-up (post 8 month exercise intervention)

Eligibility
Key inclusion criteria
Overweight (body fat > 35% or BMI > 30) post-menopausal women (>60 years) with low bone mass (>1SD below age-matched mean BMD) who are otherwise in good general health, community ambulant without a walking aid, and currently attempting to lose weight via non-exercise means (e.g. diet) that are willing to undertake an 8-month exercise program twice per week.
Minimum age
60 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent and regular participation in high intensity resistance or impact training
Less than five years post menopause
Recent fracture or musculoskeletal condition/s (e.g. low back pain or osteoarthritis) or joint surgery preventing physical activity
Contraindications for participating in heavy physical activity (i.e. uncontrolled cardiovascular disease)
Metallic implants (e.g. staples, joint replacement) or foreign bodies (e.g. shrapnel)
More than two x-ray examinations in the past year or radiation treatment
Cancer
Cognitive impairment
Certain types of current physical activity
Medications and/or conditions know to influence bone health (e.g. Paget’s Disease)

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/12/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 303754 0
Government body
Name [1] 303754 0
Queensland Health
Country [1] 303754 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
School of Allied Health Sciences
Parklands Drive, Southport
Gold Coast campus
Griffith University QLD 4222
Country
Australia
Secondary sponsor category [1] 303870 0
None
Name [1] 303870 0
N/A
Address [1] 303870 0
N/A
Country [1] 303870 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304272 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 304272 0
Ethics committee country [1] 304272 0
Australia
Date submitted for ethics approval [1] 304272 0
Approval date [1] 304272 0
10/08/2019
Ethics approval number [1] 304272 0
GU Ref 2019/543

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

Contacts
Principal investigator
Name 96362 0
Dr Benjamin Weeks
Address 96362 0
School of Allied Health Sciences
Gold Coast campus
Parklands Drive, Southport
Griffith University QLD 4222
Country 96362 0
Australia
Phone 96362 0
+61 7 5552 9336
Fax 96362 0
Email 96362 0
[email protected]
Contact person for public queries
Name 96363 0
Benjamin Weeks
Address 96363 0
School of Allied Health Sciences
Gold Coast campus
Parklands Drive, Southport
Griffith University QLD 4222
Country 96363 0
Australia
Phone 96363 0
+61 7 5552 9336
Fax 96363 0
Email 96363 0
[email protected]
Contact person for scientific queries
Name 96364 0
Benjamin Weeks
Address 96364 0
School of Allied Health Sciences
Gold Coast campus
Parklands Drive, Southport
Griffith University QLD 4222
Country 96364 0
Australia
Phone 96364 0
+61 7 5552 9336
Fax 96364 0
Email 96364 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
IPD will not be available


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.