NCT03882853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

March 30, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

March 19, 2019

Last Update Submit

September 15, 2020

Conditions

Keywords

yogaosteoporosisbalancetree poseasana

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Dynamic balance score

    5 min.

  • Berg balance test score

    10 min.

  • Timed sit and walk test score

    1 min.

  • Single leg stance test score

    1 min

  • Tandem walk test score

    1 min

  • +1 more secondary outcomes

Study Arms (2)

Conservative exercise group (CEG)

ACTIVE COMPARATOR

Conservative exercise group

Other: Conservative exercise group

Tree pose added exercise group (TPAEG)

EXPERIMENTAL

Tree pose added exercise group

Other: Conservative exercise groupOther: Tree pose added exercise group

Interventions

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.

Also known as: CEG
Conservative exercise group (CEG)Tree pose added exercise group (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.

Also known as: TPAEG
Tree pose added exercise group (TPAEG)

Eligibility Criteria

Age35 Years - 85 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with T score of bone mineral densitometry lower than -2.5.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, 34732, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ozge Solakoglu, MD

    Istanbul Medeniyet University Physical Medicine and Rehaiblitation Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Research Assistant of PMR

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 20, 2019

Study Start

March 30, 2019

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations