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

NCT03910348 | Completed DMC

• 1 other identifier: IstanbulU-Ekin Sen
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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

Conditions

Osteoporosis, Postmenopausal; Exercise Therapy

Outcome Measures

Primary Outcomes (1)

• 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

  baseline and 6 month

Secondary Outcomes (6)

• Change from Baseline Bone Formation Marker at 3-months and 6-months

  baseline, 3-month, 6-month

• Change from Baseline Bone Resorption Marker- at 3-months and 6-months

  baseline, 3-month, 6-month

• Change from Baseline Fall risk at 3-months and 6-months

  baseline, 3-month, 6-month

• Change from Baseline Functional Balance at 3-months and 6-months

  baseline, 3-month, 6-month

• Change from Baseline Health-related Quality of Life at 6 months

  baseline, 6-month

Study Arms (3)

Whole body vibration exercise

EXPERIMENTAL

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

High-impact exercise

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Whole-body vibration exercise DEVICE

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).

Whole body vibration exercise

High-impact exercise OTHER

In the high-impact exercise program, the patients were asked to jump using a jump-rope at the beginning of each session

High-impact exercise

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

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

Study Officials

• Ekin I Sen

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: January 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 10, 2019

Record last verified: 2019-04