Development and Evaluation of an Exercise Intervention for Prevention of Vertebral Osteoporosis and Deformity in Postmenopausal Women
Condition: Osteoporosis; Osteoporotic Fracture of Vertebra; Postural, Thoracic Kyphosis
MeSH terms: Osteoporosis; Kyphosis; Osteoporotic Fractures; Spinal Fractures
Study type: Interventional

Summary: 
      Osteoporotic fractures of the vertebrae (bones in the back) cause substantial pain and
      disability. Exercise could help to prevent these fractures by increasing bone strength and
      improving posture. Unfortunately, not all exercises strengthen bone. Exercises that do work
      (e.g. heavy weight lifting) are not popular with women at risk of osteoporosis. The
      investigators will develop a feasible exercise programme that can be done at a community
      centre or at home, using resistance bands. The investigators will involve women in designing
      the programme and incorporate strategies to support behaviour change. The investigators will
      then examine whether the programme improves bone density, posture or muscle strength in
      eighty women. Half the women, chosen at random, will take up exercise whilst the remaining
      half act as a control group. The investigators will take bone scans to determine bone
      density, and measure spinal curvature and strength, before and after the six- month
      programme. Findings will be useful in making recommendations as to which types of exercise
      increase spine bone density and will help to design future research on maximising vertebral
      strength. If significant benefits are seen, the investigators will develop resources such as
      booklets and videos so that the intervention can be widely available.
    

Detailed description: 
      Healthy, post-menopausal elderly women without other conditions restricting them from
      completing an exercise intervention. Inclusion criteria will be: Aged 60-80 and
      postmenopausal for at least 5 years, not taking/eligible for osteoporosis medication.
      Exclusion criteria will be: regular (>once per week) participation in high impact or high
      load resistance training, any disease or medication that contraindicates exercise or affects
      bone metabolism, meet UK criteria for pharmaceutical treatment of osteoporosis (will be
      referred to GP for treatment). The primary outcome measure will be AP lumbar spine (L1-4)
      BMD, measured by DXA using a GE Lunar iDXA densitometer. Secondary outcomes will include: BMD
      at femoral neck and lateral BMD of vertebra and hip structural parameters by DXA. Vertebral
      morphometry and dimensions, and total and regional body composition (bone, fat and lean
      masses), spinal curvature will be assessed from lateral DXA scans using statistical shape
      modelling (SSM) and the Cobb angle will be calculated as a measure of kyphosis, previous and
      current bone relevant physical activity will be assessed using a validated questionnaire,
      physical performance will be assessed using the Short Physical Performance Battery and
      functional mobility will be assessed using the Senior Fitness Test (SFT), peak force
      developed during exercises will be assessed by performing exercise using a resistance band of
      the current weight instrumented using a spring balance, postural sway will be assessed by
      measuring the movement of the centre of mass (COM), centre of foot pressure (COP), body
      segment through force platforms.

      The intervention group will be asked to take up a six-month programme of muscle strengthening
      exercises using resistance bands. Exercises will be introduced through group sessions run
      three times per week, some of which could be substituted by home exercise supported by an
      exercise booklet and video. The intervention will consist of initial spinal extension and
      core strengthening exercises to ensure good posture and form (e.g. thoracic spine extension
      and abdominal exercise avoiding spinal flexion). Exercises that increased BMD will be adapted
      for resistance bands, initially at low intensity to allow development of good technique.
      Intensity will be increased gradually by employing bands of greater stiffness until
      participants can only complete 8 repetitions without a break. Once participants can attain 12
      repetitions, intensity will be progressed by using a higher strength band. Participants will
      be advised in technique and progression at group sessions, to support transition to
      independent exercise by the end of the study.

      The intervention will include a behaviour change component that considers capability,
      opportunity and motivation using the Behaviour Change Wheel framework by using the taxonomy
      of behaviour change interventions to identify the most appropriate strategies for
      facilitating behaviour change. The nature of the intervention considers the social and
      physical limitations to opportunity to exercise, and physical and psychological capability as
      identified in the qualitative phase by incorporating a group component to exercise and
      avoiding settings such as a gym. To accord with the practical and environmental factors
      identified, sessions will be offered at a variety of times of day. Explanations of safety of
      exercise with low BMD and purpose of the exercises in the group class and booklet/video will
      underpin knowledge aspects. Participants will be encouraged to be involved in goal setting
      and action planning. This will be supported using text reminders and motivational messages or
      other support strategies. Feedback in group sessions will also reinforce reflective
      motivation. Support and implementation strategies will be continuously reviewed based upon
      findings in initial participants. The control group will be asked to continue their usual
      exercise and dietary habits as if they were not participating in the study.
    

Intervention name(s): A resistance band exercise programme; Control
Intervention type(s): Other; Other
Intervention description(s): A resistance band based exercise programme lasting six months; Maintained usual physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will be a randomised controlled trial of a six-month exercise intervention. Following screening and baseline measurements, participants will be randomly assigned to exercise or control groups, allocated in 2:1 ratio. Randomisation will conducted using computer algorithm. The exercise group will be requested to complete the intervention as detailed below whilst the control group maintain their usual lifestyle.
Participants will complete a six-month programme of muscle-strengthening exercises using resistance bands. Exercises will be introduced through group sessions run three times per week, some of which could be substituted by home exercise supported by an exercise booklet and video.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Resistance band exercise; High intensity; Osteoporosis; DXA; Bone; Exercise