The Effect of Yoga Asana 'Vrksasana (Tree Pose)' on Balance in the Patients With Osteoporosis

Study Overview
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Brief Summary
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Patients with T score of bone mineral densitometry less than or equal to -2.5 will be included in the study. Initial evaluation consists of obtaining demographic data, performing international physical activity questionnaire (short form) Additionally; Berg balance test, timed sit and walk test, single leg stance test, tandem walk test, tandem stance test will be performed. Baseline static and dynamic balance scores of patients will be determined by the Corebalance Premiere-19 balance device. After acclimation the device and tests, 3 measurements will be made and the most successful score will be taken. The lowest value will be showing best performance. After the first evaluation, patients will be randomized using windows excel randomization option to two groups by another observer. Patients will be blinded about which exercise group they will be separated to. Both groups will be thought exercise series which will be based on recommendations which is published on October 2016 by UK national osteoporosis foundation. Patients would be encouraged to perform the exercises on recommended basis and handouts will be given to patients in both groups. The yoga group will also be taught tree pose. Patients will be encouraged to note their exercises regularly on daily basis. Patients will be reevaluated after first and third months and balance tests will be re-performed to determine the effect of given exercises. Exclusion criteria Neurological or vestibule dysfunctions which may affect balance Severe mental disturbances effecting communication Locomotor dysfunction which prevents patient to perform balance tests Active musculoskeletal pathology which disrupt performing exercises.

Detailed Description
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Patients with osteoporosis who applied to PMR outpatient clinic of Istanbul Medeniyet University Goztepe Training and Research Hospital will be included in the study. Informed consent detailing the purpose and content of the study will be obtained from patients. Initial evaluation of patients will be performed by the same doctor. Initial evaluation consists of obtaining demographic data and performing international physical activity questionnaire (short form) to evaluate physical activity frequencies of patients. Additionally; Berg balance test, timed sit and walk test, single leg stance test, tandem walk test, tandem stance test will be performed. Baseline static and dynamic balance scores of patients will be determined by the Corebalance Premiere-19 balance device. After acclimation the device and tests, 3 measurements will be made and the most successful score will be taken. The lowest value will be showing best performance. After the first evaluation, patients will be randomized using windows excel randomization option to two groups by another observer. Patients will be blinded about which exercise group they will be separated to. To learn the exercises the patient will be referred to physiatrist Ozge Solakoglu who completed a 200-hour yoga teacher training programme certificated by Yoga Alliance. Both groups will be thought exercise series which will be based on recommendations which is published on October 2016 by UK national osteoporosis foundation. Patients would be encouraged to perform the exercises on recommended basis and handouts will be given to patients in both groups. The yoga group will also be taught tree pose. Patients will be encouraged to note their exercises regularly on daily basis. Patients will be reevaluated after first and third months and balance tests will be re-performed to determine the effect of given exercises. Inclusion criteria - Patients with T score of bone mineral densitometry lower than -2.5.- Exclusion criteria Neurological or vestibule dysfunctions which may affect balance Severe mental disturbances effecting communication Locomotor dysfunction which prevents patient to perform balance tests Active musculoskeletal pathology which disrupt performing exercises.

Official Title
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The Effect of Yoga Asana 'Vrksasana (Tree Pose)' on Balance in the Patients With Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Other: Conservative exercise group
* Other: Tree pose added exercise group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with T score of bone mineral densitometry lower than -2.5. Exclusion Criteria: Neurological or vestibule dysfunctions which may affect balance Severe mental disturbances effecting communication Locomotor dysfunction which prevents patient to perform balance tests Active musculoskeletal pathology which disrupt performing exercises.

Ages Eligible for Study
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Minimum Age: 35 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative exercise group (CEG)<br>Conservative exercise group | Other: Conservative exercise group<br>* The group will be thought exercise series which based on recommendations published on October 2016 by UK national osteoporosis foundation.Handouts including pictures and narrations of the exercises will be given to patients. Patients would be encouraged to perform the exercises 5 days a week. A diary will be given to note the days exercises completed.<br>* Other names: CEG;|
| Experimental: Tree pose added exercise group (TPAEG)<br>Tree pose added exercise group | Other: Conservative exercise group<br>* The group will be thought exercise series which based on recommendations published on October 2016 by UK national osteoporosis foundation.Handouts including pictures and narrations of the exercises will be given to patients. Patients would be encouraged to perform the exercises 5 days a week. A diary will be given to note the days exercises completed.<br>* Other names: CEG;Other: Tree pose added exercise group<br>* The group will be thought exercise series which will be based on recommendations which is published on October 2016 by UK national osteoporosis foundation, also be taught tree pose of yoga. Handouts including pictures and narrations of the exercises will be given to patients. Patients would be encouraged to perform the exercises 5 days a week. A diary will be given to note the days exercises completed.<br>* Other names: TPAEG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static balance score | The Korebalance Premiere-19 device and software will be used to make balance assessment. Static test requires standing steady and balancing on the platform, keeping the cross-hairs of cursor in the center of the test pattern. The score indicates the deviation of user's center of gravity from the center of the pattern. After familirization of the patient to the test, the lowest score of three measurements will be noted. The lowest score gives the most successfull scores of test. | 5 min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic balance score | The Korebalance Premiere-19 device and software will be used to make balance assessment. Dinamic test offers a moving cursor that the user ''follows''. Cursor patterns a clock-wise circle. After familirization of the patient to the test, the lowest score of three measurements will be noted. The lowest score gives the most successfull scores of test. | 5 min. | 
| Berg balance test score | 14-item scale designed to measure balance of the older adult in a clinical setting. A five-point ordinal scale, ranging from 0-4. 0 indicates the lowest level of function and 4 the highest level of function. Total Score is 56. Score of 41-56 indicates low fall risk, 21-40 indicates medium fall risk, 0 -20 indicates high fall risk. It is supported a cut off score of 45/56 for independent safe ambulation. | 10 min. | 
| Timed sit and walk test score | The objective is to determine fall risk and measure the progress of balance, sit to stand and walking. The patient starts in a seated position, the patient stands up upon command, walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. The subject is allowed to use an assistive device. If an assistive device is used, it will be documented. | 1 min. | 
| Single leg stance test score | It is used to test the static balance and postural control. It is performed eyes open and arms on the hips. The patient must stand unassisted on one leg. The time between one foot is flexed off the floor to the time when it touches the ground. If less then 30 second, it will be noted, patients stands with more than 30 seconds accepted succesfull. | 1 min | 
| Tandem walk test score | The patient will asked to walk in a straight line with one foot immediately in front of the other (heel to toe) for 10 footstep for each foot. The time will be documented. | 1 min | 
| Tandem stance test score | The patient will be ask to stand tandem (heel to toe) for 30 seconds. Lower than 30 second will be documented. | 1 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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yoga, osteoporosis, balance, tree pose, asana