The Effect of Exercise in Postmenopausal Women With Low Bone Density

Study Overview
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Brief Summary
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This clinical trial aims to evaluate the effects of a 12 month gym- and home-based exercise program on bone density and falls risk factors in postmenopausal women with low bone density. It is hypothesised that the exercise program will lead to improvements in bone density and falls risk factors such as balance and muscle strength compared with usual care.

Official Title
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The Effect of Exercise in Postmenopausal Women With Low Bone Density

Conditions
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Osteoporosis, Osteopenia

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be aged greater than 50 years Be at least 5 years post menopause (defined as the last normal menstrual bleed) Have osteopenia of the hip defined as a DXA T-score between -1 and -2.5 in one or more regions of the proximal femur (total hip, neck or trochanter regions). Have primary osteopenia Be community dwelling (not in residential care) Be able to attend an exercise program 3 times per week over the 12-month period Be able to read and write English Exclusion Criteria: Secondary causes of bone loss such as osteomalacia, glucocorticoid medication Co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition Physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise Spinal osteoporosis defined as DXA T-score <-2.5 A past vertebral fracture Body mass index > 35 or < 18. Currently on hormone replacement therapy (HRT) Current smoker Past use of HRT within the past 3 years and for more than 6 months duration Taking medication known to affect bone including oestrogen or steroid hormones Known clinically significant liver or renal disease Cancer within the past 5 years Doing regular strength training and/or weight-bearing exercise at least once per week in past 6 months Unlikely to comply with the intervention protocol

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Exercise performed at the gym and at home | Behavioral: Exercise<br>* Exercise performed at gym and at home comprising strength, balance and impact exercise<br>|
| No Intervention: 2<br>Usual care no additional exercise | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density measured using DXA at the lumbar spine and proximal femur |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls risk factors |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Exercise, Low bone density, Falls