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

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoporosis
• Intervention / Treatment: Other: Clinical pilates; Other: Whole body vibration

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 Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 340
    • Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Clinical pilates; Exercises will be performed two times per week for twelve weeks.	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.
EXPERIMENTAL: Whole body vibration; Exercises will be performed two times per week for twelve weeks.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Tetrax fall index	Tetrax fall index will be calculated to determine fall risk.	Change in Tetrax fall index from baseline to twelve weeks
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
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
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
Urinary deoxypyridinoline	Urinary deoxypyridinoline level will be measured to assess bone resorption.	Change in urinary deoxypyridinoline level from baseline to twelve weeks

Collaborators and Investigators

• Sponsor: Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2018
• Primary Completion (ANTICIPATED): April 15, 2020
• Study Completion (ANTICIPATED): May 15, 2020

Study Registration Dates

• First Submitted: February 2, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (ACTUAL): February 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 5, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; balance; strength; whole body vibration; flexibility; postmenopausal osteoporosis; bone turnover markers; clinical pilates
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: Ece Korkmaz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No