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Effects of Whole-Body Vibration and High Impact Exercises in Postmenopausal Women

Primary Purpose

Osteoporosis, Postmenopausal, Exercise Therapy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole-body vibration exercise
High-impact exercise
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Postmenopausal women aged 40-65 years old
  • Bone mineral density T-scores between -2.0 and -3.0 at the L1-L4, L2-L4, femoral neck, trochanter and/or total hip regions
  • Serum 25(OH)vitamin D level ≥ 30 ng/ml.

Exclusion Criteria:

  • The use of any medications and/or disease that affect bone metabolism
  • Neuromuscular performance, and/or balance; presence of cardiovascular, pulmonary, neuromuscular, and/or chronic diseases that affect exercise training
  • Presence of an osteoporotic fracture
  • Presence of a musculoskeletal disease, such as an acute lumbar herniated disc and/or spondylolisthesis
  • Presence of gall or kidney stones, prostheses, intraocular lenses, and/or implants
  • Body mass index ≥35 kg/m²
  • Thrombosis history

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Whole body vibration exercise

    High-impact exercise

    Control

    Arm Description

    The WBV training consisted of a high frequency (30-40 Hz) vibration stimulus at a low setting (2-4mm peak to peak) on a Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA). Each patient received the vibrations under supervision using five different static positions: squat, deep squat, widestep squat, lunge, and hands-front lunge. The exercise programs for each experimental groups consisted of 20 to 60-minute sessions on three days per week for 24 weeks, and they were performed under the supervision.

    Depending on their individual calcium and vitamin D intakes, each patient advised to receive supplemental calcium and vitamin D to ensure a total daily intake of 1,500 mg of calcium and 880 IU of vitamin D.

    Depending on their individual calcium and vitamin D intakes, each patient received supplemental calcium and vitamin D to ensure a total daily intake of 1,500 mg of calcium and 880 IU of vitamin D. The demographic characteristics of the participants were obtained at the baseline assessment.

    Outcomes

    Primary Outcome Measures

    Change from Baseline Bone Mineral Density at 6 months
    The bone mineral density of the lumbar spine, femoral neck were measured with a dual energy x-ray absorptiometry

    Secondary Outcome Measures

    Change from Baseline Bone Formation Marker at 3-months and 6-months
    The serum osteocalcin (OC) level
    Change from Baseline Bone Resorption Marker- at 3-months and 6-months
    The serum C-terminal telopeptide of type I collagen (CTx) levels
    Change from Baseline Fall risk at 3-months and 6-months
    A computerized static posturography device was used to measure the fall index
    Change from Baseline Functional Balance at 3-months and 6-months
    Timed Up and Go (TUG) test
    Change from Baseline Health-related Quality of Life at 6 months
    Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
    Change from Baseline Depressive Symptoms at 6 months
    Beck Depression Inventory

    Full Information

    First Posted
    April 8, 2019
    Last Updated
    April 9, 2019
    Sponsor
    Istanbul University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03910348
    Brief Title
    Effects of Whole-Body Vibration and High Impact Exercises in Postmenopausal Women
    Official Title
    Effects of Whole-Body Vibration and High Impact Exercises on the Bone Metabolism and Fall Risk in Postmenopausal Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (Actual)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    September 2011 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    We investigated the effects of whole body vibration (WBV) and high-impact (HI) exercises in postmenopausal women with low bone mineral density. In summary, WBV exercises are effective in preventing bone loss and WBV and HI exercise programs are effective in decreasing fall risk, increasing health-related quality of life and improving depressive symptoms
    Detailed Description
    Purpose: The aim of this study was to determine the effects of six months of supervised whole-body vibration (WBV) and high-impact (HI) exercises on bone mineral density (BMD), serum bone turnover markers, fall risk, health-related quality of life (HRQoL) and depressive symptoms in postmenopausal women, additionally, to evaluate the advantage of each training program to another. Methods: In a prospective, randomized controlled 6-month interventional trial 58 eligible postmenopausal women were assigned to WBV training group (n=19), HI training group (n=19), or control group (n=20). The patients in both training groups participated in a supervised training program, which consisted of the one-hour exercise session three times a week for six months. The WBV groups received vibration (30-35 Hz, 2-4 mm) in five different static positions. The HI group jumped rope (10-50 jumps/day). All patients received calcium (1000 mg) and vitamin D (880 IU) supplementation per day. In all participants, baseline and six-month BMD at the lumbar spine and femur were measured by Dual-energy X-ray Absorptiometry (DXA). Serum osteocalcin (OC) and C-terminal telopeptide of type I collagen (CTx) were measured at baseline, three- and six-month intervals. Fall risk was assessed by using the Timed Up and Go (TUG) test and fall index measured by static posturography at baseline, three- and six-month intervals. HRQoL and depressive symptoms were assessed using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Beck Depression Inventory (BDI), respectively, at baseline and six-month of the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis, Postmenopausal, Exercise Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Whole body vibration exercise
    Arm Type
    Experimental
    Arm Description
    The WBV training consisted of a high frequency (30-40 Hz) vibration stimulus at a low setting (2-4mm peak to peak) on a Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA). Each patient received the vibrations under supervision using five different static positions: squat, deep squat, widestep squat, lunge, and hands-front lunge. The exercise programs for each experimental groups consisted of 20 to 60-minute sessions on three days per week for 24 weeks, and they were performed under the supervision.
    Arm Title
    High-impact exercise
    Arm Type
    Experimental
    Arm Description
    Depending on their individual calcium and vitamin D intakes, each patient advised to receive supplemental calcium and vitamin D to ensure a total daily intake of 1,500 mg of calcium and 880 IU of vitamin D.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Depending on their individual calcium and vitamin D intakes, each patient received supplemental calcium and vitamin D to ensure a total daily intake of 1,500 mg of calcium and 880 IU of vitamin D. The demographic characteristics of the participants were obtained at the baseline assessment.
    Intervention Type
    Device
    Intervention Name(s)
    Whole-body vibration exercise
    Intervention Description
    The WBV training consisted of a high frequency (30-40 Hz) vibration stimulus at a low setting on a Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA).
    Intervention Type
    Other
    Intervention Name(s)
    High-impact exercise
    Intervention Description
    In the high-impact exercise program, the patients were asked to jump using a jump-rope at the beginning of each session
    Primary Outcome Measure Information:
    Title
    Change from Baseline Bone Mineral Density at 6 months
    Description
    The bone mineral density of the lumbar spine, femoral neck were measured with a dual energy x-ray absorptiometry
    Time Frame
    baseline and 6 month
    Secondary Outcome Measure Information:
    Title
    Change from Baseline Bone Formation Marker at 3-months and 6-months
    Description
    The serum osteocalcin (OC) level
    Time Frame
    baseline, 3-month, 6-month
    Title
    Change from Baseline Bone Resorption Marker- at 3-months and 6-months
    Description
    The serum C-terminal telopeptide of type I collagen (CTx) levels
    Time Frame
    baseline, 3-month, 6-month
    Title
    Change from Baseline Fall risk at 3-months and 6-months
    Description
    A computerized static posturography device was used to measure the fall index
    Time Frame
    baseline, 3-month, 6-month
    Title
    Change from Baseline Functional Balance at 3-months and 6-months
    Description
    Timed Up and Go (TUG) test
    Time Frame
    baseline, 3-month, 6-month
    Title
    Change from Baseline Health-related Quality of Life at 6 months
    Description
    Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
    Time Frame
    baseline, 6-month
    Title
    Change from Baseline Depressive Symptoms at 6 months
    Description
    Beck Depression Inventory
    Time Frame
    baseline, 3-month, 6-month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Postmenopausal women aged 40-65 years old Bone mineral density T-scores between -2.0 and -3.0 at the L1-L4, L2-L4, femoral neck, trochanter and/or total hip regions Serum 25(OH)vitamin D level ≥ 30 ng/ml. Exclusion Criteria: The use of any medications and/or disease that affect bone metabolism Neuromuscular performance, and/or balance; presence of cardiovascular, pulmonary, neuromuscular, and/or chronic diseases that affect exercise training Presence of an osteoporotic fracture Presence of a musculoskeletal disease, such as an acute lumbar herniated disc and/or spondylolisthesis Presence of gall or kidney stones, prostheses, intraocular lenses, and/or implants Body mass index ≥35 kg/m² Thrombosis history
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ekin I Sen
    Organizational Affiliation
    Istanbul University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effects of Whole-Body Vibration and High Impact Exercises in Postmenopausal Women

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