Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Study Overview
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Brief Summary
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The aim of the 6 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in postmenopausal women with low bone mass.

Detailed Description
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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.

Official Title
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Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Conditions
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Osteopenia, Osteoporosis, Postmenopausal Osteoporosis, Sarcopenia

Intervention / Treatment
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* Other: Exercise training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Postmenopausal women will be randomly assigned to exercise or no exercise group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training<br>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. | Other: Exercise training<br>* Progressive muscle resistive exercise will be performed by the experimental group only. Control group will maintain their normal level of daily activity.<br>|
| No Intervention: Control<br>The control group will be asked to maintain their normal lifestyle and will be advised to continue their standard care of treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density measured by magnetic resonance imaging (MRI) technique | Change in trabecular density assessed using MRI technique. An increase in trabecular density is expected at the end of the study. | Baseline | 
| Bone density measured by magnetic resonance imaging (MRI) technique | Change in trabecular density assessed using MRI technique. An increase in trabecular density is expected at the end of the study. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Change in quadriceps muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study | Baseline | 
| Muscle strength | Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study | 1 month | 
| Muscle strength | Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study. | 3 months | 
| Muscle strength | Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study. | 6 months | 
| Serum bone biomarker: Bone Alkaline Phosphatase (BAP) | Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study. | Baseline | 
| Serum bone biomarker: Bone Alkaline Phosphatase (BAP) | Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study. | 1 month | 
| Serum bone biomarker: Bone Alkaline Phosphatase (BAP) | Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study. | 3 months | 
| Serum bone biomarker: Bone Alkaline Phosphatase (BAP) | Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study. | 6 months | 
| Physical activity: International Physical Activity Questionnaire (IPAQ) | Change in metabolic equivalent (MET)-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study. | baseline | 
| Physical activity: International Physical Activity Questionnaire (IPAQ) | Change in MET-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study. | 1 month | 
| Physical activity: International Physical Activity Questionnaire (IPAQ) | Change in MET-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study. | 3 month | 
| Physical activity: International Physical Activity Questionnaire (IPAQ) | Change in MET-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study. | 6 months | 
| Oxygen uptake (VO2) | Change in VO2 assessed using metabolic cart. A greater value of VO2 is expected at the end of this study. | Baseline | 
| Oxygen uptake (VO2) | Change in VO2 assessed using metabolic cart. A greater value of VO2 is expected at the end of this study. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aging, bone, muscle, exercise