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

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ClinicalTrials.gov Identifier: NCT03910348
Recruitment Status : Completed
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Ekin Ilke Sen, Istanbul University

Study Description
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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

Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Exercise Therapy Device: Whole-body vibration exercise Other: High-impact exercise Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Whole-Body Vibration and High Impact Exercises on the Bone Metabolism and Fall Risk in Postmenopausal Women
Actual Study Start Date : January 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : September 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Whole body vibration exercise
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.
 Device: Whole-body vibration exercise
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).
Experimental: High-impact exercise
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.
 Other: High-impact exercise
In the high-impact exercise program, the patients were asked to jump using a jump-rope at the beginning of each session
No Intervention: Control
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Bone Mineral Density at 6 months [ Time Frame: baseline and 6 month ]
    The bone mineral density of the lumbar spine, femoral neck were measured with a dual energy x-ray absorptiometry


Secondary Outcome Measures :
  1. Change from Baseline Bone Formation Marker at 3-months and 6-months [ Time Frame: baseline, 3-month, 6-month ]
    The serum osteocalcin (OC) level

  2. Change from Baseline Bone Resorption Marker- at 3-months and 6-months [ Time Frame: baseline, 3-month, 6-month ]
    The serum C-terminal telopeptide of type I collagen (CTx) levels

  3. Change from Baseline Fall risk at 3-months and 6-months [ Time Frame: baseline, 3-month, 6-month ]
    A computerized static posturography device was used to measure the fall index

  4. Change from Baseline Functional Balance at 3-months and 6-months [ Time Frame: baseline, 3-month, 6-month ]
    Timed Up and Go (TUG) test

  5. Change from Baseline Health-related Quality of Life at 6 months [ Time Frame: baseline, 6-month ]
    Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)

  6. Change from Baseline Depressive Symptoms at 6 months [ Time Frame: baseline, 3-month, 6-month ]
    Beck Depression Inventory


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910348


Sponsors and Collaborators
Istanbul University
Investigators
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Principal Investigator: Ekin I Sen Istanbul University
More Information
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Responsible Party: Ekin Ilke Sen, Medical doctor, Istanbul University
ClinicalTrials.gov Identifier: NCT03910348    
Other Study ID Numbers: IstanbulU-Ekin Sen
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
 Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases