None listed
Conditions
Brief summary
Osteopenia and osteoporosis is characterised by low bone mineral density (BMD) and associated with increased fracture risk in older adults. OsteoStrong® provides high-intensity progressive resistance training in a supervised setting, which may improve bone health in older adults with poor bone health. This pilot cohort study will primarily investigate the feasibility and safety of a 8-month exercise intervention undertaken by OsteoStrong® in 44 post-menopausal women with low BMD. The study will also determine if this intervention will result in significant improvements in BMD, bone quality, muscle composition and physical function.
Interventions
OsteoStrong® provides high-intensity progressive resistance training in a supervised setting, which may improve bone health in older adults with poor bone health. This pilot cohort study will investigate the feasibility, safety and efficacy of an 8-month exercise intervention undertaken by OsteoStrong® in postmenopausal women with low bone mineral density. Participants will be provided with a free OsteoStrong® membership for 8 months and will complete supervised, individual training at their pre
OsteoStrong® provides high-intensity progressive resistance training in a supervised setting, which may improve bone health in older adults with poor bone health. This pilot cohort study will investigate the feasibility, safety and efficacy of an 8-month exercise intervention undertaken by OsteoStrong® in postmenopausal women with low bone mineral density. Participants will be provided with a free OsteoStrong® membership for 8 months and will complete supervised, individual training at their preferred OsteoStrong® location (Hawthorn, South Melbourne or Ballarat centre). Exercise prescribed by OsteoStrong® will be individually tailored considering initial fitness, injuries or illness but follow the same procedures. The intensity and force of the exercise will increase progressively over 8 months, while the frequency and duration of the exercise sessions remain constant at once a week. OsteoStrong® utilises four exercise machines that display the force a participant exerts during each activity. Under the supervision of a trained OsteoStrong® technician, participants will be instructed to engage to their perceived maximum force/loading level on each machine while not reaching a point of discomfort. All four exercises are limited-range static load contractions with minimal change in joint angle. Exertion on each machine will last 8 to 10 seconds. The display screen on each machine will report and record participants' maximum effort. A central database will store the force data for each participant on each machine. The total time for this circuit is four to six minutes, with the total amount of exertion per participant being less than one minute. To ensure safe transition to this form of progressive resistance training, participants who are deemed deconditioned or have had previous injuries will be instructed to apply only 50% of their maximum effort for the initial session, to be gradually increased over subsequent exercise sessions. All other participants will be encouraged to exert 70-80% of their 1 repetition maximum (1RM) at the first exercise session. At each session, both trainer and participant can view the maximal force achieved for each machine in the previous session. The participant is encouraged to exceed their previous output at each weekly session or minimally achieve 75% of their previous week's force production.
Sponsors
David Scott
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Experienced menopause - Low bone mineral density (<-1.0 T-score at lumbar spine, non-dominant total hip or femoral neck). Confirmed by DXA scan performed by investigators or self-reported diagnosis in past two years (confirmed by GP) - Community-dwelling - GP approval to participate in progressive resistance training - Body mass index (BMI) <30kg/m2 - <150 minutes of self-reported moderate-vigorous physical activity per week
Exclusion criteria
- Lower- or upper-limb joint injury or surgery in the past 6 months - Participation in more than or equal to 4 weeks of structured exercise regime in the past 3 months (eg. running program, resistance training) - Self-reported inability to walk 400 metres, non-stop and unassisted - Non-English speaking - Unwilling to travel to Monash Medical Centre for screening, baseline and 8 month assessments - Expected travel for >1 month over the next 8 months - Body weight >200kg (upper weight limit for DXA) - DXA T-score less than or equal -3.0 at any site - Use of drugs that interfere with bone metabolism in the past 2 years (eg. bisphosphonates, teriparatide, denosumab, hormone replacement therapy, ranitidine, esomeprazole) - Regular corticosteroid use in the past 3 months - Self-reported knee or hip osteoarthritis (or other musculoskeletal conditions) causing severe pain during exercise - Maximum hand grip strength < 16kg determined by hand dynamometry - Active hernia or recent hernia operation in the past 6 months - Currently diagnosed conditions known to influence bone health (eg. thyrotoxicosis, current primary hyperparathyroidism, Paget’s disease, eGFR<30 mLs/min, osteogenesis imperfecta, immobility etc) - Currently diagnosed conditions known to influence calcium or vitamin D intake (eg. Celiac disease, Inflammatory bowel disease) - Type 1 or 2 Diabetes mellitus - Diet low in calcium (<1000mg/day) or protein (<0.8g/kg/day) as determined from a short food frequency questionnaire - Insufficient vitamin D from sun exposure (For individuals with moderately fair skin, <6 minutes daily in December to January with arms exposed, and <25 minutes daily in July to August at midday, with as much bare skin exposed. Individuals with highly pigmented skin would require 3 times the minimum duration.) - Hypertension (systolic/diastolic blood pressure >140/90) not treated by medication - High-risk alcohol consumption (more than 14 standard drinks per week) - Current smoker - Progressive neurological disorder. (eg. Parkinson’s disease, Alzheimer’s disease, Multiple Sclerosis) - Lung disease requiring supplemental oxygen - Myocardial infarction or severe cardiovascular disease - Any other severe disorder where life expectancy is <12 months - Any other condition (eg. muscular dystrophy, non-functional limb, paraplegia, quadriplegia) that in the opinion of the investigators may affect a person’s ability to reach minimum osteogenic loading target during test period
Outcome results
None listed