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

NCT04259697 | Unknown

• 1 other identifier: Ece Korkmaz
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

postmenopausal osteoporosis; clinical pilates; whole body vibration; bone turnover markers; strength; flexibility; balance; quality of life

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Clinical pilates

EXPERIMENTAL

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

Other: Clinical pilates

Whole body vibration

EXPERIMENTAL

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

Other: Whole body vibration

Interventions

Clinical pilates OTHER

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.

Clinical pilates

Whole body vibration OTHER

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.

Whole body vibration

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Izmir, 340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoporosis; Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A controlled study

Study Record Dates

• First Submitted: February 2, 2020
• First Posted: February 6, 2020
• Study Start: January 15, 2018
• Primary Completion: April 15, 2020
• Study Completion: May 15, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Locations

TU (1)