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Completed

NCT Number: NCT03882853

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

35 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, 34732, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conservative exercise group

Other

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.

Other names: CEG

Tree pose added exercise group

Other

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.

Other names: TPAEG

Primary outcomes

  1. Static balance score

    Time frame: 5 min.

    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 outcomes

  1. Dynamic balance score

    Time frame: 5 min.

    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.

  2. Berg balance test score

    Time frame: 10 min.

    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.

  3. Timed sit and walk test score

    Time frame: 1 min.

    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.

  4. Single leg stance test score

    Time frame: 1 min

    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.

  5. Tandem walk test score

    Time frame: 1 min

    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.

  6. Tandem stance test score

    Time frame: 1 min

    The patient will be ask to stand tandem (heel to toe) for 30 seconds. Lower than 30 second will be documented.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2019
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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