The Effect of Horizontal Whole-body Vibration Therapy in Post-menopausal Women

NCT05182281 | Completed

• 1 other identifier: feyzaakan
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoporosis is an important public health issue that may result in a high fracture risk in the elderly population. There is general consensus that physical exercise decreases the risk of osteoporotic fractures by reducing the risk of falls and increasing bone strength. Although long-term high-intensity exercise programs have been shown to be successful in early post-menopausal women, a high-intensity exercise program appears to be less attractive to older post-menopausal women and may cause a lack of compliance in the long term and result in injury. Some studies have described falls and fractures as side effects of exercise.Whole-body vibration (WBV) therapy is an easy-to-apply alternative therapy for those who do not wish to initiate or continue pharmacological treatments and cannot perform high-impact exercises and is associated with high patient compliance. WBV therapy is among the promising new interventions for the prevention and treatment of osteoporosis and is defined as mechanical vibration applied in a standing or supine position without any restrictions on frequency (hertz), amplitude (millimeters), magnitude (vibration acceleration due to gravity, g) and cumulative WBV dose. The evidence obtained from animal studies have shown that WBV can be an effective method for increasing bone mass and improving bone structure and strength. Some human studies have shown that WBV can positively affect BMD and improve neuromuscular parameters associated with falls in post-menopausal women.Small changes in posture can have a significant effect on the extent to which a plantar-based mechanical stimulus is actually transmitted to the spine or hip; the stimulus is likely to be weakened by the inevitable changes in posture, which occur due to aging and osteoporosis. For these reasons, we aimed to examine the effect of high frequency and low-magnitude horizontal vibration therapy in post-menopausal women without being affected by posture in the present study.

Conditions

Osteoporosis; Whole Body Vibration

Keywords

Osteoporosis; Whole-body vibration; Bone mineral density; Quality of life

Outcome Measures

Primary Outcomes (5)

• Body Mass Density

  BMD (g/cm²) of the lumbar, femoral neck, and entire femoral regions of all patients was measured at the onset and end of the treatment using dual energy x-ray absorptiometry (General Electric LUNAR Prodigy Advance).

  3 months

• Bone Turnover Markers

  Serum samples were taken from all patients between 08:00 and 10:00 in the morning after 12 hours of fasting. Urine samples were analyzed in the first morning urine. We checked the values of osteocalcin (OC) as a bone formation marker and hydroxyproline/creatinine values as a bone resorption marker.

  3 months

• The Short Form-36

  The Short Form-36 (SF-36) is a widely used health-related quality of life scale. It is not specific to any age, disease, or treatment group. It includes general health concepts. It is a questionnaire containing 36 questions in 8 subscales. SF-36 scale can be examined under 2 main sections as physical and mental health. Patients are scored out of 100 points in the SF-36 scale and the scores obtained vary between 0 and 100 points for each component. High scores on this scale indicate a better level of health, whereas low scores indicate deterioration of health.

  3 months

• Visual analog scale

  Pain was evaluated according to the visual analog scale (0: no pain; 10 very severe pain). They were asked to describe their back pain on the scale choosing a number from 0 to 10 (10-cm VAS).

  3 months

• Berg Balance Test

  Berg Balance test (BBT) assesses whether people can maintain their balance during 14 different activities. The level of competence in the activity for each item is scored between 0 and 4 with 0 indicating the lowest score (incapable of doing) and 4 indicating the highest score (doing it independently and safely). The maximum score obtainable is 56. Higher scores indicate better balance .

  3 months

Study Arms (3)

Whole Body Vibration and Infrared Therapy Group

EXPERIMENTAL

Patients in the whole body vibration and infrared group received vibration therapy with a frequency of 60 Hz and amplitude of 0.5-2 mm and infrared therapy at a wavelength of 550-950 nm 20 minutes daily session, 2 days per weeks for 3 months.1000 mg Ca and 880 IU vitamin D treatment were given.

Device: Whole Body Vibration and Infrared Therapy

Infrared Therapy Group

ACTIVE COMPARATOR

Patients in infrared therapy group received infrared therapy at a wavelength of 550-950 nm 20 minutes daily session, 2 days per weeks for 3 months.1000 mg Ca and 880 IU vitamin D treatment were given.

Device: Infrared Therapy

Classical Treatment Group

OTHER

1000 mg Ca and 880 IU vitamin D treatment were given.

Other: Classical Treatment

Interventions

Whole Body Vibration and Infrared Therapy DEVICE

Patients in the whole body vibration and infrared group received vibration therapy with a frequency of 60 Hz and amplitude of 0.5-2 mm and infrared therapy at a wavelength of 550-950 nm. Whole body vibration and infrared treatment were applied with the Power Andullator (HHP, CE0197, Germany) device.

Whole Body Vibration and Infrared Therapy Group

Infrared Therapy DEVICE

Patients in infrared therapy group received infrared therapy at a wavelength of 550-950 nm.Infrared treatment were applied with the Power Andullator (HHP, CE0197, Germany) device.

Infrared Therapy Group

Classical Treatment OTHER

1000 mg Ca and 880 IU vitamin D treatment were given

Classical Treatment Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal female patients
• Aged 45-65 years
• L2-L4 and/or femoral neck BMD T-scores of -2.5 to-3.

You may not qualify if:

• Osteoporotic fractures
• Metabolic bone disease
• Hyperparathyroidism
• Presence of hyperthyroidism
• History of steroids or current use of steroids
• History of bisphosphonate consumption over the previous year
• Women with lumbar disk herniation, spondylolisthesis or narrow spinal canal
• Conditions that constitute a contraindication for vibration therapy;
• Kidney stones
• Gallstones
• Pregnancy
• Epilepsy
• Cancer
• Pacemaker
• Treatment of orthostatic hypotension

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Feyza Akan BEGOGLU

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Feyza Akan Begoğlu

  Fatih Sultan Mehmet Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 10, 2022
• Study Start: May 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)