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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04259697
• Other study ID #: Ece Korkmaz
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: May 15, 2020

Study information

• Verified date: February 2020
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: May 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Clinical pilates
Clinical pilates exercises will be performed progressively. The duration of each exercise session will be an average of 40 minutes initially and then will be increased to 60 minutes as the program progress.
• Whole body vibration
Whole body vibration exercises will be performed using the Power Plate pro5 AIRdaptive machine.The duration of each exercise session will be an average of 20 minutes initially and then will be increased to 30 minutes as the program progress.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University, School of Physical Therapy and Rehabilitation	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

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