Clinical trial NCT03882853: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: yoga
osteoporosis
balance
tree pose
asana
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 32
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Static balance score
timeFrame: 5 min.
Secondary outcomes:
measure: Dynamic balance score
timeFrame: 5 min.
measure: Berg balance test score
timeFrame: 10 min.
measure: Timed sit and walk test score
timeFrame: 1 min.
measure: Single leg stance test score
timeFrame: 1 min
measure: Tandem walk test score
timeFrame: 1 min
measure: Tandem stance test score
timeFrame: 1 min
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
Study officials:
affiliation: Istanbul Medeniyet University Physical Medicine and Rehaiblitation Clinic
name: Ozge Solakoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.