Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001444471
Ethics application status
Approved
Date submitted
14/10/2016
Date registered
17/10/2016
Date last updated
19/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The OPTIMA-Ex trial: Osteoporosis Prevention Through Impact and Muscle-loading Approaches to Exercise
Scientific title
A comparison of the bone response to impact loading versus resistance training: a randomised controlled trial of upper and lower limb responses in young heathy women with lower than average bone mass.
Secondary ID [1] 290329 0
None
Universal Trial Number (UTN)
Trial acronym
OPTIMA-Ex
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low bone mass 300593 0
Osteopenia 300595 0
Osteoporosis 300596 0
Condition category
Condition code
Musculoskeletal 300446 300446 0 0
Osteoporosis
Physical Medicine / Rehabilitation 300447 300447 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a three-arm, single blind randomised controlled exercise intervention trial. Eligible participants are randomized to 10-month, twice-weekly, either supervised high intensity resistance training, high intensity impact training or a “sham active” control group.

Arm 1 – supervised heavy progressive resistance training.
Participants allocated to the resistance training intervention group attend twice-weekly 45 minute instructor-led sessions performed on non-consecutive days. Six compound exercises (deadlift, back squat, bench press, overhead press, bent over row and calf raise) using olympic weights will be completed each session. For each exercise, 5 sets of 3-5 repetitions, corresponding to an intensity of 85 % of 1 repetition maximum will be performed under the supervision of a physiotherapist. Measurements of 1 RM will take place every 12 weeks to ensure sufficient progression of resistance training exercises. Compliance and weight lifted is monitored via training diaries which each participant completes at the end of each session.

Arm 2 – supervised high-intensity impact loading exercise.
Participants allocated to the impact training intervention group attend twice-weekly 40 minute instructor-led high intensity impact training sessions performed on non-consecutive days. Participants will be taught three fundamental upper limb loading exercises in the form of punches (jab, cross and lead hook) as well as complete three fundamental lower limb impact exercises (jump, hop and drop jump) under the supervision of a physiotherapist. The fundamental exercises will be performed throughout the remainder of the intervention period with progressively increasing height and complexity of jumps and force of landing with participants progressing from shod to barefoot after the familiarisation phase as well as the power and complexity of punching combinations to maintain an RPE of greater than 8 out of 10. Measures of punch kinematics will take place at 2, 4, 12, 24, 36 and 44 weeks using a GymAware device to ensure that participants continue to increase the loading and speed of their punches throughout the training intervention. Compliance is monitored via training diaries which each participant completes at the end of each session.
Intervention code [1] 296140 0
Prevention
Intervention code [2] 296141 0
Lifestyle
Comparator / control treatment
Arm 3 –
A low load, home-based unsupervised exercise program will serve as a positive control. Participants will be asked to exercise twice per week for approximately 30 minutes. The sessions consist of shadow boxing and low load and body weight exercises in a low intensity circuit training format. Participants are instructed on how to perform all exercises at the initial testing session; they are also provided with an exercise handout and have access to a private YouTube channel, as well as contacted weekly via email. Compliance is monitored via training diaries which each participant completes at the end of each session.
Control group
Active

Outcomes
Primary outcome [1] 299882 0
Bilateral proximal femur (femoral neck, trochanter and total hip regions of interest) bone mineral density and 3D variables determined by Dual-energy X-ray Absorptiometry.
Timepoint [1] 299882 0
All participants, pre (baseline) and post-intervention (10 months).
Primary outcome [2] 299883 0
Lumbar spine (L2-L4) bone mineral density determined by Dual-energy X-ray Absorptiometry.
Timepoint [2] 299883 0
All participants, pre (baseline) and post-intervention (10 months).
Primary outcome [3] 299884 0
Whole body bone mineral density determined by Dual-energy X-ray Absorptiometry .
Timepoint [3] 299884 0
All participants, pre (baseline) and post-intervention (10 months)
Secondary outcome [1] 328381 0
Bilateral leg bone strength variables (trabecular and cortical content, density and area, bone strength index and polar section modulus) determined from peripheral Quantitative Computed Tomography .
Timepoint [1] 328381 0
All participants, pre (baseline) and post-intervention (10 months).
Secondary outcome [2] 328382 0
Bilateral forearms bone strength variables (trabecular and cortical content, density and area, bone strength index and polar section modulus) determined from peripheral Quantitative Computed Tomography.
Timepoint [2] 328382 0
All participants, pre (baseline) and post-intervention (10 months).
Secondary outcome [3] 328383 0
Bilateral leg Muscle volume and density determined from peripheral Quantitative Computed Tomography.
Timepoint [3] 328383 0
All participants, pre (baseline) and post-intervention (10 months).
Secondary outcome [4] 328384 0
Bilateral forearm Muscle volume and density determined from peripheral Quantitative Computed Tomography.
Timepoint [4] 328384 0
All participants, pre (baseline) and post-intervention (10 months).
Secondary outcome [5] 328387 0
Heel bone quality (Broadband Ultrasound Attenuation, Speed of Sound and Stiffness Index) determined by Quantitative Ultrasonometry.
Timepoint [5] 328387 0
All participants, pre (baseline) and post-intervention (10 months).
Secondary outcome [6] 328389 0
Body composition (lean mass, fat mass, appendicular lean mass and percentage body fat) from whole body Dual-energy X-ray Absorptiometry.
Timepoint [6] 328389 0
All participants, pre (baseline) and post-intervention (10 months).
Secondary outcome [7] 328390 0
Muscle force will be measured via handheld dynamometry using previously validated techniques (maximal isometric leg strength, thoracic extension muscle strength and grip strength).
Timepoint [7] 328390 0
All participants, pre (baseline) and post-intervention (10 months).
Secondary outcome [8] 328391 0
Relative impulse to be determined using vertical jump measure on an in-ground force plate.
Timepoint [8] 328391 0
All participants, pre (baseline) and post-intervention (10 months).
Secondary outcome [9] 328392 0
Physical activity enjoyment using the modified PACES questionnaires.
Timepoint [9] 328392 0
All participants, pre (baseline) and post-intervention (10 months).
Secondary outcome [10] 328393 0
Daily average calcium intake using the validated AusCal questionnaire.
Timepoint [10] 328393 0
All participants, pre (baseline) and post-intervention (10 months).
Secondary outcome [11] 328394 0
Historical bone relevant physical activity using the validated 'Bone-specific Physical Activity' (BPAQ) questionnaire.
Timepoint [11] 328394 0
All participants, pre (baseline) and post-intervention (10 months).
Secondary outcome [12] 328395 0
Quality of life using the validated AQoL-6D questionnaire.
Timepoint [12] 328395 0
All participants, pre (baseline) and post intervention (10 months).
Secondary outcome [13] 328396 0
Safety (adverse events and injuries) and compliance from training diaries across the whole exercise intervention period.
Timepoint [13] 328396 0
Across the intervention period (10 months).

Eligibility
Key inclusion criteria
Female
Apparently healthy
With lower than average bone mineral density (hip or spine BMD T-score less than or equal to 0)
Unaccustomed to resistance training and impact loading exercise
Minimum age
18 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Musculoskeletal or medical conditions affecting the ability to perform high intensity physical activity, , medications or medical conditions known to effect bone health, cancer, uncontrolled cardiovascular disease, greater than 2 X-ray’s in the past 12 months and current participation in a regular exercise program known to influence bone or previous competitive or regular participation (more than 1 x per week for 1 year or one full season) in resistance training or boxing (including other fight sports and martial arts), gymnastics/dance sports (gymnastics, ballet, aerobics, cheerleading), court sports (volleyball, basketball, netball), ball sports (Australian rules, rugby league/union, soccer, touch) or racquet sports (badminton, squash, tennis) over the past 4 years.

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)
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


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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
8/11/2016
Actual
11/11/2016
Date of last participant enrolment
Anticipated
Actual
29/03/2018
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
100
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294708 0
University
Name [1] 294708 0
Griffith University
Country [1] 294708 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] 293556 0
None
Name [1] 293556 0
Address [1] 293556 0
Country [1] 293556 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296132 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 296132 0
Ethics committee country [1] 296132 0
Australia
Date submitted for ethics approval [1] 296132 0
06/10/2015
Approval date [1] 296132 0
28/10/2015
Ethics approval number [1] 296132 0
GU Ref: 2015/775

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

Contacts
Principal investigator
Name 69670 0
Dr Benjamin Weeks
Address 69670 0
Menzies Health Institute QLD
School of Allied Health Sciences
Gold Coast campus
Griffith University
Parklands Drive
Southport, Gold Coast,
Queensland, 4222
Country 69670 0
Australia
Phone 69670 0
+61 7 5552 9336
Fax 69670 0
Email 69670 0
[email protected]
Contact person for public queries
Name 69671 0
Benjamin Weeks
Address 69671 0
Menzies Health Institute QLD
School of Allied Health Sciences
Gold Coast campus
Griffith University
Parklands Drive
Southport, Gold Coast,
Queensland, 4222
Country 69671 0
Australia
Phone 69671 0
+61 7 5552 9336
Fax 69671 0
Email 69671 0
[email protected]
Contact person for scientific queries
Name 69672 0
Benjamin Weeks
Address 69672 0
Menzies Health Institute QLD
School of Allied Health Sciences
Gold Coast campus
Griffith University
Parklands Drive
Southport, Gold Coast,
Queensland, 4222
Country 69672 0
Australia
Phone 69672 0
+61 7 5552 9336
Fax 69672 0
Email 69672 0
[email protected]

No information has been provided regarding IPD availability


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.