OsteoporosisNCT03882853
The Effect of Yoga Asana 'Vrksasana (Tree Pose)' on Balance in the Patients With Osteoporosis
A study testing Conservative exercise group and Tree pose added exercise group in people with Osteoporosis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 85 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Conservative exercise group and Tree pose added exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with T score of bone mineral densitometry lower than -2.5.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
Istanbul, 34732
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Conservative exercise group, Tree pose added exercise group
- Keywords
- yoga, osteoporosis, balance, tree pose, asana
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative exercise groupOther
Also called CEG
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.
Tree pose added exercise groupOther
Also called TPAEG
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.
| Study group | Role | What they receive |
|---|---|---|
| Conservative exercise group (CEG) | Active comparator | Conservative exercise group Receives: Other: Conservative exercise group |
| Tree pose added exercise group (TPAEG) | Experimental | Tree pose added exercise group Receives: Other: Conservative exercise group; Other: Tree pose added exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 min.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start30 Mar 2019
- Primary completion30 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
- Investigators
- Ozge Solakoglu, MD, Principal investigator, Istanbul Medeniyet University Physical Medicine and Rehaiblitation Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882853
- Sponsor's protocol ID
- FTR OP
- Status last verified
- Sep 2020
- First submitted
- 19 Mar 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33990483
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga Asana 'Vrksasana (Tree Pose)' on Balance in the Patients With Osteoporosis
- ClinicalTrials.gov ID
- NCT03882853
- Acronym / sponsor ID
- FTR OP
- Conditions
- Osteoporosis
- Keywords
- yoga, osteoporosis, balance, tree pose, asana
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative exercise group (CEG) | Active comparator | Other: Conservative exercise groupConservative exercise group |
| Tree pose added exercise group (TPAEG) | Experimental | Other: Conservative exercise group, Other: Tree pose added exercise groupTree pose added exercise group |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with T score of bone mineral densitometry lower than -2.5.
Key exclusion criteria (4 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative exercise groupAlso: CEGThe 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 | Conservative exercise group (CEG), Tree pose added exercise group (TPAEG) |
| Tree pose added exercise groupAlso: TPAEGThe 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 | Tree pose added exercise group (TPAEG) |
Primary outcome
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.
6 secondary outcomes
Dynamic balance score
Time frame: 5 min.
Berg balance test score
Time frame: 10 min.
Timed sit and walk test score
Time frame: 1 min.
Single leg stance test score
Time frame: 1 min
Tandem walk test score
Time frame: 1 min
Tandem stance test score
Time frame: 1 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 33990483Solakoglu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozge Solakoglu, MD principal investigator
Istanbul Medeniyet University Physical Medicine and Rehaiblitation Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative exercise group and Tree pose added exercise group in people with Osteoporosis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance score (time frame: 5 min.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03882853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.