The OPTIMA-Ex trial: Osteoporosis Prevention Through Impact and Muscle-loading Approaches to Exercise

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001444471
• Date of registration: 17/10/2016
• Prospective Registration: Yes
• Primary sponsor: Griffith University
• 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.
• Date of first enrolment: 11/11/2016
• Target sample size: 100
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12616001444471.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Benjamin Weeks

• Name: Dr Benjamin Weeks

Key inclusion & exclusion criteria

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

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.

Age minimum: 18 Years
Age maximum: 30 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Low bone mass;Osteopenia;Osteoporosis;
Low bone mass
Osteopenia
Osteoporosis

Musculoskeletal - Osteoporosis

Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

Intervention(s)

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 progressi

Primary Outcome(s)

Whole body bone mineral density determined by Dual-energy X-ray Absorptiometry .[All participants, pre (baseline) and post-intervention (10 months)]

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.[All participants, pre (baseline) and post-intervention (10 months).]

Lumbar spine (L2-L4) bone mineral density determined by Dual-energy X-ray Absorptiometry.[All participants, pre (baseline) and post-intervention (10 months).]

Secondary Outcome(s)

Bilateral forearm Muscle volume and density determined from peripheral Quantitative Computed Tomography.[All participants, pre (baseline) and post-intervention (10 months).]

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 .[All participants, pre (baseline) and post-intervention (10 months).]

Physical activity enjoyment using the modified PACES questionnaires.[All participants, pre (baseline) and post-intervention (10 months).]

Body composition (lean mass, fat mass, appendicular lean mass and percentage body fat) from whole body Dual-energy X-ray Absorptiometry.[All participants, pre (baseline) and post-intervention (10 months).]

Daily average calcium intake using the validated AusCal questionnaire.[All participants, pre (baseline) and post-intervention (10 months).]

Quality of life using the validated AQoL-6D questionnaire.[All participants, pre (baseline) and post intervention (10 months).]

Relative impulse to be determined using vertical jump measure on an in-ground force plate.[All participants, pre (baseline) and post-intervention (10 months).]

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.[All participants, pre (baseline) and post-intervention (10 months).]

Bilateral leg Muscle volume and density determined from peripheral Quantitative Computed Tomography.[All participants, pre (baseline) and post-intervention (10 months).]

Muscle force will be measured via handheld dynamometry using previously validated techniques (maximal isometric leg strength, thoracic extension muscle strength and grip strength).[All participants, pre (baseline) and post-intervention (10 months).]

Heel bone quality (Broadband Ultrasound Attenuation, Speed of Sound and Stiffness Index) determined by Quantitative Ultrasonometry.[All participants, pre (baseline) and post-intervention (10 months).]

Historical bone relevant physical activity using the validated 'Bone-specific Physical Activity' (BPAQ) questionnaire.[All participants, pre (baseline) and post-intervention (10 months).]

Safety (adverse events and injuries) and compliance from training diaries across the whole exercise intervention period.[Across the intervention period (10 months).]

Secondary ID(s)

None

Source(s) of Monetary Support

Griffith University

Ethics review

Status: Approved
Approval date:
Contact:

Griffith University Human Research Ethics Committee