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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conservative exercise group
Tree pose added exercise group
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring yoga, osteoporosis, balance, tree pose, asana

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conservative exercise group (CEG)

Tree pose added exercise group (TPAEG)

Arm Description

Conservative exercise group

Tree pose added exercise group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 19, 2019
Last Updated
September 15, 2020
Sponsor
Istanbul Medeniyet University
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1. Study Identification

Unique Protocol Identification Number
NCT03882853
Brief Title
The Effect of Yoga Asana 'Vrksasana (Tree Pose)' on Balance in the Patients With Osteoporosis
Official Title
The Effect of Yoga Asana 'Vrksasana (Tree Pose)' on Balance in the Patients With Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 30, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
yoga, osteoporosis, balance, tree pose, asana

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative exercise group (CEG)
Arm Type
Active Comparator
Arm Description
Conservative exercise group
Arm Title
Tree pose added exercise group (TPAEG)
Arm Type
Experimental
Arm Description
Tree pose added exercise group
Intervention Type
Other
Intervention Name(s)
Conservative exercise group
Other Intervention Name(s)
CEG
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tree pose added exercise group
Other Intervention Name(s)
TPAEG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Static balance score
Description
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.
Time Frame
5 min.
Secondary Outcome Measure Information:
Title
Dynamic balance score
Description
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.
Time Frame
5 min.
Title
Berg balance test score
Description
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.
Time Frame
10 min.
Title
Timed sit and walk test score
Description
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.
Time Frame
1 min.
Title
Single leg stance test score
Description
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.
Time Frame
1 min
Title
Tandem walk test score
Description
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.
Time Frame
1 min
Title
Tandem stance test score
Description
The patient will be ask to stand tandem (heel to toe) for 30 seconds. Lower than 30 second will be documented.
Time Frame
1 min

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozge Solakoglu, MD
Organizational Affiliation
Istanbul Medeniyet University Physical Medicine and Rehaiblitation Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
City
Istanbul
ZIP/Postal Code
34732
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33990483
Citation
Solakoglu O, Dogruoz Karatekin B, Yumusakhuylu Y, Mesci E, Icagasioglu A. The Effect of Yoga Asana "Vrksasana (Tree Pose)" on Balance in Patients With Postmenopausal Osteoporosis: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Mar 1;101(3):255-261. doi: 10.1097/PHM.0000000000001785.
Results Reference
derived

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

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