None listed
Conditions
Brief summary
For the many individuals with established osteoporosis who will not, or cannot take medication there are currently no recommended therapeutic alternatives. Calcium and vitamin D are vital but insufficient therapies and are similarly limited by poor patient compliance. Recent evidence suggests high intensity exercise is an effective stimulus for bone. Whole body vibration (WBV) can also be anabolic to the musculoskeletal system. Early research has shown that WBV is a simple, passive therapy with greater appeal to the target population than exercise or drugs. This trial will be the first to use rigorous methods to examine the effects of WBV alone, and in combination with high-intensity exercise, in participants on and off bone medications, to improve risk factors for hip fracture (bone density, balance and muscle strength).
Interventions
Arm 1. WBV: Participants will stand on the 30 Hz WBV device installed in their home for 10-minutes 5 days per week for 9 months. Compliance is recorded by the device.
Arm 2. HiRIT: Participants will attend Griffith University for a 30-minute high intensity resistance and impact training (HiRIT) session, supervised by a trained exercise physiologist or exercise scientist, twice per week for 9 months. A participant diary will be completed every session.
Arm 3. HiRIT + WBV: Participants will stan
Arm 1. WBV: Participants will stand on the 30 Hz WBV device installed in their home for 10-minutes 5 days per week for 9 months. Compliance is recorded by the device. Arm 2. HiRIT: Participants will attend Griffith University for a 30-minute high intensity resistance and impact training (HiRIT) session, supervised by a trained exercise physiologist or exercise scientist, twice per week for 9 months. A participant diary will be completed every session. Arm 3. HiRIT + WBV: Participants will stand on the WBV device installed in their home for 10-minutes 5 days per week for 9 months, and attend Griffith University for a 30-minute high intensity resistance and impact training (HiRIT) session, supervised by a trained exercise physiologist or exercise scientist, twice per week for 9 months. Compliance is recorded by the device, and a participant diary will be completed every session.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1) women 2) at least 5 year post-menopause 3) with low bone mineral density (hip BMD t score less than or equal to -1.0) 4) with or without anti-absorptive osteoporosis drug with no plans to change therapy for the next 21 months 5) willing and able to attend twice-weekly on-campus training and 5 times a week in-home WBV 6) weigh less than 125 kg
Exclusion criteria
1) Fraility 2) Inability to stand unaided 3) Cognitive impairment 4) Moderate to high levels of bone-relevant physical activity in previous 8 months 5) Regular use of vibration plate in last 8 months 6) Malignancy 6) On the following medications, Strontium ranelate or anabolic osteoporosis medication e.g. parathyroid hormone, corticosteroids, thyroxine, thiazide or anti-viral agents 7) Have conditions known to influence bone health e.g. thyrotoxicosis or hyperthyroidism, Paget's disease, renal diseases and diabetes, or to prevent engaging in HiRIT without risk.
Outcome results
None listed