Effects of Clinical Pilates and Whole Body Vibration Exercises in Postmenopausal Osteoporotic Women

Not Applicable

• Conditions: Osteoporosis
• Interventions: Other: Clinical pilates; Other: Whole body vibration

• Registration Number: NCT04259697
• Lead Sponsor: Dokuz Eylul University

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.

Study Timeline

• Study Start: 2018-01-15
• Status Verified: 2020-02
• Study First Submitted: 2020-02-02
• Study First Submitted QC: 2020-02-05
• Last Update Submitted: 2020-02-05
• Study First Posted: 2020-02-06
• Last Update Posted: 2020-02-06
• Primary Completion: 2020-04-15
• Study Completion: 2020-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinical pilates	Clinical pilates	Exercises will be performed two times per week for twelve weeks.
Whole body vibration	Whole body vibration	Exercises will be performed two times per week for twelve weeks.

Primary Outcome Measures

Name	Time	Method
The maximum hold time on unipedal stance and on tandem stance.	Change in the maximum hold time from baseline to twelve weeks	The maximum hold time will be calculated to assess static balance.
Plasma sclerostin concentration	Change in plasma sclerostin concentration from baseline to twelve weeks	Plasma sclerostin concentration will be measured to assess the process of bone resorption and formation.
Timed up and go test	Change in Timed up and go test from baseline to twelve weeks	Timed up and go test will be used to assess dynamic balance.
Dual-energy X-ray absorptiometry of hip and lumbar spine	Change in the Dual-energy X-ray absorptiometry of hip and lumbar spine from baseline to twelve weeks	Dual-energy X-ray absorptiometry of hip and lumbar spine will be measured to assess bone density.
Strength	Change in strength measures from baseline to twelve weeks	The strength of the extensor muscles of the hip, knee, back, elbow will be assessed with a hand-held dynamometer.
Tetrax fall index	Change in Tetrax fall index from baseline to twelve weeks	Tetrax fall index will be calculated to determine fall risk.
The short form-12 questionnaire	Change in quality of life measure from baseline to twelve weeks	The short form-12 questionnaire will be used to assess quality of life. The total score can range from 0 to 100. Lower SF-12 score indicated poorer physical and mental health.
Urinary deoxypyridinoline	Change in urinary deoxypyridinoline level from baseline to twelve weeks	Urinary deoxypyridinoline level will be measured to assess bone resorption.
Flexibility	Change in flexibility measures from baseline to twelve weeks	Flexibility wil be assessed measuring the fingertip-to-floor distance in flexion and lateral bending.

Trial Locations

Locations (1)

Dokuz Eylul University, School of Physical Therapy and Rehabilitation; 🇹🇷 Izmir, Turkey