| Registry | NCT05060380 |
|---|---|
| Status | Withdrawn - The study was never started. |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Sponsor | University of Alabama at Birmingham (Other) |
| Conditions | Osteopenia, Osteoporosis, Postmenopausal Osteoporosis, Sarcopenia |
| Interventions | Exercise training (Other) |
| Dates | start 2026-12-01 (estimated), primary completion 2028-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2021-09-29, last updated 2026-07-01 |
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All trials for Osteopenia All trials for Osteoporosis All trials of Exercise training
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Exercise training | Experimental | Other: Exercise training | 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. |
Sex: Female, ages: 55 Years to 70 Years
Inclusion Criteria: * independent ambulatory * diagnosed with low bone mass Exclusion Criteria: * uncontrolled hypertension * secondary osteoporosis * fragility fracture, * clinical or laboratory evidence of hepatic * renal disease, * uncontrolled disorders of the parathyroid * thyroid glands, * a history of cancer in the past 5 years, * any structured resistance training within the previous year, and * past therapy with any drug for osteoporosis, * any current therapy for osteoporosis except zoledronic acid, * inability to walk independently or * any other medical conditions which could restrict the potential participants from full participation as decided by their physician.