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The study was never started.
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The aim of the 2 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in individuals with low bone mass.
In 2008, medical cost of osteoporosis and osteoporosis-related fractures was estimated to be $22 billion. This is further expected to rise because of an increase of 20% in population with osteoporosis, amounting to 12 million adults over the age of 50 years, by 2020, out of which 80% will be postmenopausal women. Unfortunately, benefits due to pharmacological interventions have plateaued. Consequently, there is a critical need to identify complementary therapies to enhance the treatment of low bone mass in older adults. The aim of this study is to examine the feasibility of novel progressive muscle resistance exercise in postmenopausal women with low bone mass. Muscle will be assessed via imaging techniques and isokinetic dynamometer. Physical activity will be assessed via activity monitors. Blood will be collected to assess bone and muscle biomarkers. Balance will be assessed via clinical and biomechanical tests. Testing will be performed at 4 time points: baseline, 1 month, 3 month, and 6 months except imaging which will be done at the baseline and 6 months. The findings from this study will help us to understand the feasibility of resistive muscle exercise program in postmenopausal women with low bone mass.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training | Experimental | The exercise training group will receive progressive muscle resistive exercise, 10 sets of exercises for 2 times per week for a total of 6 months. |
|
| Control | No Intervention | The control group will be asked to maintain their normal lifestyle and will be advised to continue their standard care of treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training | Other | Progressive muscle resistive exercise will be performed by the experimental group only. Control group will maintain their normal level of daily activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone biomarker | bone formation and resorption marker | baseline |
| Bone biomarker | bone formation and resorption marker | 1 month |
| Bone biomarker | bone formation and resorption marker | 2 month |
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Inclusion Criteria:
Exclusion Criteria:
Self-identified as female.
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| Name | Affiliation | Role |
|---|---|---|
| HARSHVARDHAN SINGH, PT, PhD | University of Alabama at Birmingham | Principal Investigator |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| D015663 | Osteoporosis, Postmenopausal |
| D055948 | Sarcopenia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Individuals will be randomly assigned to exercise or no exercise group.
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Outcomes assessor will be blinded to the group assignment.
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |