Clinical trial NCT04259697: Effects of Clinical Pilates and Whole Body Vibration Exercises in Postmenopausal Osteoporotic Women
Official title: Comparison of the Effects of Clinical Pilates and Whole Body Vibration Exercises on Strength, Flexibility, Balance, Bone Turnover Markers and Quality of Life in Postmenopausal Osteoporotic Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Keywords: postmenopausal osteoporosis
clinical pilates
whole body vibration
bone turnover markers
strength
flexibility
balance
quality of life
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 34
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A controlled study
Primary purpose: TREATMENT

Brief summary: The aim is to compare the effects of clinical pilates and whole body vibration exercises in postmenopausal osteoporotic women on strength, flexibility, balance, bone turnover markers and quality of life.

Detailed description: The aim of this study is to compare the effects of clinical pilates and whole body vibration exercises in postmenopausal osteoporotic women in terms of strength, flexibility, balance, bone turnover markers and quality of life. Thirty-four women who are diagnosed with postmenopausal osteoporosis will be recruited into the study. Participants will be divided into two groups: (1) clinical pilates group, (2) vibration exercises group. Exercise programs will be performed two times per week for twelve weeks. The strength of the extensor muscles of the hip, knee, back, elbow will be measured with a hand-held dynamometer. Flexibility will be assessed measuring the fingertip-to-floor distance in flexion and lateral bending. The balance performance will be assessed using the timed up and go test, Tetrax fall index and the maximum hold time on unipedal stance and on tandem stance. The short form-12 questionnaire will be used to assess the quality of life. Also, bone turnover markers will be measured. All assessments will be performed before and after exercise programs.

Eligibility criteria: Inclusion Criteria:

* Being in the postmenopausal period
* Having body mass index equal to or greater than 18,5 kg/m²
* A lack of regular exercise
* Having been diagnosed with osteoporosis
* Having the ability to walk independently

Exclusion Criteria:

* Having a cardiopulmonary problem that may prevent participating in exercise programs
* Having kidney stones
* Being diagnosed with diabetes
* Presence of epilepsy
* Having cardiological problems such as arrhythmia, using a pacemaker, hypertension
* Having neurological disorders such as Parkinson, stroke, multiple sclerosis, neuropathy
* Having surgery in the last 6 months

Primary outcomes:
measure: Strength
timeFrame: Change in strength measures from baseline to twelve weeks
measure: Flexibility
timeFrame: Change in flexibility measures from baseline to twelve weeks
measure: Timed up and go test
timeFrame: Change in Timed up and go test from baseline to twelve weeks
measure: The maximum hold time on unipedal stance and on tandem stance.
timeFrame: Change in the maximum hold time from baseline to twelve weeks
measure: Tetrax fall index
timeFrame: Change in Tetrax fall index from baseline to twelve weeks
measure: The short form-12 questionnaire
timeFrame: Change in quality of life measure from baseline to twelve weeks
measure: Dual-energy X-ray absorptiometry of hip and lumbar spine
timeFrame: Change in the Dual-energy X-ray absorptiometry of hip and lumbar spine from baseline to twelve weeks
measure: Plasma sclerostin concentration
timeFrame: Change in plasma sclerostin concentration from baseline to twelve weeks
measure: Urinary deoxypyridinoline
timeFrame: Change in urinary deoxypyridinoline level from baseline to twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University, School of Physical Therapy and Rehabilitation
Study officials:
References: