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

6. ledna 2022 aktualizováno: Fatih Sultan Mehmet Training and Research Hospital

The Effect of Horizontal Whole-body Vibration Therapy on Bone, Quality of Life, Pain, and Balance in Post-menopausal Women

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

In this prospective, randomized controlled 3-month study, 185 post-menopausal women who were diagnosed with osteoporosis and followed up in our outpatient clinic based on the osteoporosis diagnostic criteria by the World Health Organization were analyzed.According to the inclusion and exclusion criteria, 60 patients were included in the study.

The patients included in the study were randomized by the co-researcher into 3 groups of 20 patients each according to the random numbers table. Group 1 received WBV and infrared therapy for 20 minutes per session, 2 days a week for 3 months. Group 2 received only infrared therapy for 20 minutes, 2 days a week for 3 months, in the same bed system. The patients were placed in the supine position with the whole body in contact with the platform/bed during the treatment. In terms of compliance with the WBV therapy, the frequency was increased to 30 Hz in the first week, 40 Hz in the second week, 50 Hz in the third week, and 60 Hz in the fourth week and administered for a total of 20 minutes. Subsequent sessions continued with 60 Hz. The acceleration value administered by the device was 2.0-4.0 m/s², and the amplitude of the applied vibration in the vertical direction was 0.5-2.0 mm.Infrared therapy at a wavelength of 550-950 nm was applied to both groups of patients by means of infrared pads on the bed during the treatment.Group 3 did not receive any treatment. Patients in all 3 groups continued their treatment with 1000 mg Ca and 880 IU vitamin D. The patients were called every week by phone to check whether they were complying with the treatment or not.Bone mineral density (BMD) of the lumbar and femoral regions of all the patients was measured using dual energy x-ray absorptiometry. In addition, osteocalcin and hydroxyproline values were measured. Quality of life was assessed using the Short Form-36 questionnaire, pain was assessed using the visual analog scale, and balance was assessed based on the participants' performance in the Berg Balance test.The scales were applied at the beginning and at the end of the treatment.

Typ studie

Intervenční

Zápis (Aktuální)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Krocan
      • Istanbul, Krocan
        • Feyza Akan BEGOGLU

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

45 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Recent implants (joint, cochlear, or corneal)
  • Recent surgery
  • Recent intrauterine device
  • Acute thrombosis or hernia
  • Acute rheumatoid arthritis
  • Serious cardiovascular event
  • Diabetes
  • Migraine

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Whole Body Vibration and Infrared Therapy Group
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.
Přístroj: Whole Body Vibration and Infrared Therapy
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.
Aktivní komparátor: Infrared Therapy Group
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.
Přístroj: Infrared Therapy
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.
Jiný: Classical Treatment Group
1000 mg Ca and 880 IU vitamin D treatment were given.
Jiný: Classical Treatment
1000 mg Ca and 880 IU vitamin D treatment were given

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Body Mass Density
Časové okno: 3 months
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
Časové okno: 3 months
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
Časové okno: 3 months
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
Časové okno: 3 months
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
Časové okno: 3 months
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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Fatih Sultan Mehmet Training and Research Hospital

Vyšetřovatelé

  • Vrchní vyšetřovatel: Feyza Akan Begoğlu, Fatih Sultan Mehmet Training and Research Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. května 2015

Primární dokončení (Aktuální)

1. srpna 2015

Dokončení studie (Aktuální)

1. srpna 2015

Termíny zápisu do studia

První předloženo

17. prosince 2021

První předloženo, které splnilo kritéria kontroly kvality

6. ledna 2022

První zveřejněno (Aktuální)

10. ledna 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

10. ledna 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. ledna 2022

Naposledy ověřeno

1. prosince 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

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Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Ne

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