The Effect of Horizontal Whole-body Vibration Therapy in Post-menopausal Women
The Effect of Horizontal Whole-body Vibration Therapy on Bone, Quality of Life, Pain, and Balance in Post-menopausal Women
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Istanbul, Turquie
- Feyza Akan BEGOGLU
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Comparateur actif: 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.
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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.
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Autre: Classical Treatment Group
1000 mg Ca and 880 IU vitamin D treatment were given.
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1000 mg Ca and 880 IU vitamin D treatment were given
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Body Mass Density
Délai: 3 months
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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).
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3 months
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Bone Turnover Markers
Délai: 3 months
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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.
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3 months
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The Short Form-36
Délai: 3 months
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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.
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3 months
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Visual analog scale
Délai: 3 months
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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).
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3 months
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Berg Balance Test
Délai: 3 months
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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 .
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3 months
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Feyza Akan Begoğlu, Fatih Sultan Mehmet Training and Research Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- feyzaakan
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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