High Intensity Multi-Modal Exercise Training in Postmenopausal Women

Study Overview
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Brief Summary
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in Pakistan 9.9 million people are osteoporotic and 7.2 million amongst them are women. Globally after every 3 seconds there is occurrence of fragility fracture.In Pakistan females carries different risk factors based on distinct culture, environment, diet and lifestyle. So there is dire need to conduct more high quality clinical trials at National level in order to establish strong evidence in favor of low cost but highly effective exercise protocols for such a significant public health issue.

Detailed Description
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In postmenopausal age, women bones get weak and easily fracture after 50years. In Pakistan every other female is silently suffering from this disease leading to bone, joint pain and disability. This project is innovatively designed first time in Pakistan to target weak bones of women with high intensity, progressive exercise training. The objectives of this study are to determine the effects of a high intensity multi-modal exercise training on bone mineral density and functional performance in postmenopausal women. After initial screening based on history, subjective fracture risk calculations and subjective osteoporosis screening. Females fulfilling criteria and willing to participate in exercise trial will be recruited in the study. At baseline, DEXA scan will be done for Femoral and lumbar bone density. All performance based testing for functional performance outcome measures would be done at baseline, after 3 months & after 6 months. Patient will be called twice a week for 8months and DEXA will be repeated after 8months of training. It is hypothesized that supervised exercise training will improve bone mineral density and functional performance in postmenopausal women with low bone mass.

Official Title
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Effects of High Intensity Multi-Modal Exercise Training on Bone Density and Functional Performance in Postmenopausal Women

Conditions
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Postmenopausal Osteoporosis, Postmenopausal Osteopenia

Intervention / Treatment
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* Other: High Intensity Exercises
* Other: General Exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal Women, at least 3 years since last mensuration. Age: 45-70years Body mass index (BMI) <30kg/m2 Community ambulant without walking aid Good general health Willing for exercise therapy Exclusion Criteria: History of fragility fracture in addition to BMD T-score of -2.5 or less MMSE < 20 Taking Hormone replacement therapy or steroids from last 1 year. Had participated in regular exercise for last 1 year Systemic illness: hyperthyroidism, hyperparathyroidism, Diabetes Mellitus, renal failure, any malignancy, extensive radiation exposure Any orthopedic injury/disorder hindering performance of exercise.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 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
Interventional Model Description: This will be a Single factor, Pretest-Postest Control group Design with parallel assignment of patients into two groups.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIT-MMEX Group<br>In this group Supervised High intensity Progressive Resistance Training, High intensity weightbearing/Impact exercises and High challenging Balance Training will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months. | Other: High Intensity Exercises<br>* Supervised High intensity Progressive Resistance Training, High intensity weightbearing/Impact exercises and High challenging Balance Training will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months.<br>|
| Active Comparator: Control Group<br>In this Group Supervised general fitness exercises including general body stretches, treadmill walking, mild to moderate intensity progressive resistance training & balance exercises will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months. | Other: General Exercises<br>* Supervised general fitness exercises including general body stretches, treadmill walking, mild to moderate intensity progressive resistance training & balance exercises will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femoral Neck BMD (FN BMD) | Change from Baseline in Femoral Neck Bone Mineral Density measured by DEXA scan | 8 Months | 
| Lumbar Spine BMD (LS BMD) | Change from Baseline in Lumbar Spine Bone Mineral Density measured by DEXA scan | 8 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 RM for Leg Extensors | Changes from the baseline, 1 RM Is used to assess maximum muscle strength. Patient will be asked to perform leg press that is to extend knee against maximum resistance once. weight will be recorded in Kgs. | 3 Months | 
| 1 RM for Leg Extensors | Changes from 3 Months, 1 RM Is used to assess maximum muscle strength. Patient will be asked to perform leg press that is to extend knee against maximum resistance once. weight will be recorded in Kgs. | 6 Months | 
| 1 RM for Trunk Extensors | Changes Baseline, 1 RM Is used to assess maximum muscle strength. Patient will be asked to perform deadlift, maximum weight lifted will be recorded in Kgs. | 3 Months | 
| 1 RM for Trunk Extensors | Changes from 3 Months, 1 RM Is used to assess maximum muscle strength. Patient will be asked to perform deadlift, maximum weight lifted will be recorded in Kgs. | 6 Months | 
| 30-second sit to stand test (Reps) | Changes from Baseline, It involves counting the number of times the participant can rise to a full standing position from the seated position on a chair without using the arms | 3 Months | 
| 30-second sit to stand test (Reps) | Changes from 3 Months, It involves counting the number of times the participant can rise to a full standing position from the seated position on a chair without using the arms | 6 Months | 
| Time up and Go test | Changes from Baseline, participants will be instructed to walk at usual speed for three meter and then walk back to sit down .Note time on stopwatch .The average of tests trail will be measured as the mean of TUG. | 3 Months | 
| Time up and Go test | Changes from 3 Months, participants will be instructed to walk at usual speed for three meter and then walk back to sit down .Note time on stopwatch .The average of tests trail will be measured as the mean of TUG. | 6 Months | 
| Dynamic Gait Index | Changes from Baseline, DGI was Developed to assess the likelihood of falling in older adults. Designed to test eight facets of gait. A four-point ordinal scale, ranging from 0-3. 0 indicates the lowest level of function and 3 the highest level of function. Total Score is 24 | 3 Months | 
| Dynamic Gait Index | Changes from 3 months, DGI was Developed to assess the likelihood of falling in older adults. Designed to test eight facets of gait. A four-point ordinal scale, ranging from 0-3. 0 indicates the lowest level of function and 3 the highest level of function. Total Score is 24 | 6 Months | 
| Falls Efficacy Scale | Changes from Baseline, On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, patient will be asked how confident are you that you do the given activities without falling. A total score of greater than 70 indicates that the person has a fear of falling. | 3 Months | 
| Falls Efficacy Scale | Changes from 3Months, On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, patient will be asked how confident are you that you do the given activities without falling. A total score of greater than 70 indicates that the person has a fear of falling. | 6 Months | 
| Berg balance scale | Changes from Baseline, The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait. | 3 Months | 
| Berg balance scale | Changes from 3Months, The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait. | 6 Months | 
| Functional Reach Test (FRT) | Changes from Baseline, it is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support. | 3 Months | 
| Functional Reach Test (FRT) | Changes from 3 months, it is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support. | 6 Months |