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

Primary Purpose

Osteoporosis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Clinical pilates
Whole body vibration
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring postmenopausal osteoporosis, clinical pilates, whole body vibration, bone turnover markers, strength, flexibility, balance, quality of life

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Clinical pilates

Whole body vibration

Arm Description

Exercises will be performed two times per week for twelve weeks.

Exercises will be performed two times per week for twelve weeks.

Outcomes

Primary Outcome Measures

Strength
The strength of the extensor muscles of the hip, knee, back, elbow will be assessed with a hand-held dynamometer.
Flexibility
Flexibility wil be assessed measuring the fingertip-to-floor distance in flexion and lateral bending.
Timed up and go test
Timed up and go test will be used to assess dynamic balance.
The maximum hold time on unipedal stance and on tandem stance.
The maximum hold time will be calculated to assess static balance.
Tetrax fall index
Tetrax fall index will be calculated to determine fall risk.
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.
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.
Plasma sclerostin concentration
Plasma sclerostin concentration will be measured to assess the process of bone resorption and formation.
Urinary deoxypyridinoline
Urinary deoxypyridinoline level will be measured to assess bone resorption.

Secondary Outcome Measures

Full Information

First Posted
February 2, 2020
Last Updated
February 5, 2020
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04259697
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
April 15, 2020 (Anticipated)
Study Completion Date
May 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
postmenopausal osteoporosis, clinical pilates, whole body vibration, bone turnover markers, strength, flexibility, balance, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A controlled study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical pilates
Arm Type
Experimental
Arm Description
Exercises will be performed two times per week for twelve weeks.
Arm Title
Whole body vibration
Arm Type
Experimental
Arm Description
Exercises will be performed two times per week for twelve weeks.
Intervention Type
Other
Intervention Name(s)
Clinical pilates
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Whole body vibration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Strength
Description
The strength of the extensor muscles of the hip, knee, back, elbow will be assessed with a hand-held dynamometer.
Time Frame
Change in strength measures from baseline to twelve weeks
Title
Flexibility
Description
Flexibility wil be assessed measuring the fingertip-to-floor distance in flexion and lateral bending.
Time Frame
Change in flexibility measures from baseline to twelve weeks
Title
Timed up and go test
Description
Timed up and go test will be used to assess dynamic balance.
Time Frame
Change in Timed up and go test from baseline to twelve weeks
Title
The maximum hold time on unipedal stance and on tandem stance.
Description
The maximum hold time will be calculated to assess static balance.
Time Frame
Change in the maximum hold time from baseline to twelve weeks
Title
Tetrax fall index
Description
Tetrax fall index will be calculated to determine fall risk.
Time Frame
Change in Tetrax fall index from baseline to twelve weeks
Title
The short form-12 questionnaire
Description
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.
Time Frame
Change in quality of life measure from baseline to twelve weeks
Title
Dual-energy X-ray absorptiometry of hip and lumbar spine
Description
Dual-energy X-ray absorptiometry of hip and lumbar spine will be measured to assess bone density.
Time Frame
Change in the Dual-energy X-ray absorptiometry of hip and lumbar spine from baseline to twelve weeks
Title
Plasma sclerostin concentration
Description
Plasma sclerostin concentration will be measured to assess the process of bone resorption and formation.
Time Frame
Change in plasma sclerostin concentration from baseline to twelve weeks
Title
Urinary deoxypyridinoline
Description
Urinary deoxypyridinoline level will be measured to assess bone resorption.
Time Frame
Change in urinary deoxypyridinoline level from baseline to twelve weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dokuz Eylul University, School of Physical Therapy and Rehabilitation
City
Izmir
ZIP/Postal Code
340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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