Effect Whole Body Vibration on Balance in Post Diabetic Menopause Women

Effect of Whole Body Vibration on Balance in Post Menopause Diabetic Women

Postmenopausal diabetic women have significant balance deficits and increased fall risk. Whole-body vibration may improve balance in these population but needs further research. The purpose of the current study was to determine the effect of whole-body vibration on balance in postmenopausal diabetic women.

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy; Postmenopausal Women
• Intervention / Treatment: Other: Whole body vibration; Other: Balance training

Detailed Description

Background: Menopause is characterized by reduced androgens produced by ovaries, which negatively affect women health including metabolism and quality of life (QoL) and sexual function. Purpose: This study investigates the effect of whole-body vibration on balance and QoL in postmenopausal diabetic women. Methods: Forty postmenopausal women with diabetic neuropathy will participate in this study aged from 50 to 65 years. They will be randomly distributed into two equal groups: Group A (study group): will receive whole body vibration (WBV) and balancing exercise. Group B (control group): will receive the same balancing exercises as group A. The treatment will be performed 3 times per week for 12 weeks. Dynamic balance will be assessed by Biodex Balance System (BBS) that assesses (Overall stability index [OSI], anteroposterior stability index [APSI] and mediolateral stability index [MLSI)], Berg Balance test (BBT) and Time up and go test (TUG). Quality of life will be assessed by menopous specific in Quality of Life questionnaire before and after the treatment.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Haven Police and El Bagour specialized Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inclusion Criteria:

Patients were examined by a gynaecologist before the study and were selected according to the following criteria:

• Diabetic postmenopausal women who suffered from peripheral neuropathy
• Their ages ranged from 50 to 65 years.
• Body Mass Indices (BMI) ≤ 30kg/m2
• They were medically stable.

Exclusion Criteria:

• Patients were examined by a gynaecologist before the study and were excluded if they had:

  • Inner ear disturbance.
  • Musculoskeletal problems.
  • Active tuberculosis and tumours.
  • Implanted cardiac rhythm devices.
  • Any hormonal replacement therapy or drug treatment that could affect normal metabolism of musculoskeletal system.
  • Habitual exercise or participate in any supervised exercise.
  • Hypo- or hyperparathyroidism, renal, liver, or chronic disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WBV group; consisted of twenty postmenopausal women with diabetic neuropathy who received whole body vibration and balancing exercise (three times per week for 12 weeks).	Other: Whole body vibration; All women in group (A) received whole body vibration and balance board training, three times per week for three months. Parameters: The WBV was performed by using whole body vibration which is a side-alternating vibration device working as a teeterboard with amplitude of 0 to 5.3 mm (medial to distal) and a variable frequency of 5 to 30 Hz. The amplitude was controlled by adjusting the foot position from 1 to 3, with the larger the position, the greater the amplitude. Before the treatment, procedures of using the Galileo 900 were instructed by the research assistant and its safety issues explained. Patient's position: The patient was asked to stand on WBV device by Hold hand support for those elderly women. the vibrating platform in a 100 to 110° squat position, the oscillating platform operating at 20Hz in bare feet at the second foot position for 15 minutes a day for 3 days a week for 3 months. All unusual or uncomfortable complaints from subjects during the WBV treatment were docu; Other: Balance training; Balance training exercises treatment: All women in both group (A, B) received balance training exercises on balance ball, half ball and balance board exercises three times per week for 3 months
Active Comparator: Balance group; consisted of twenty postmenopausal women with diabetic neuropathy who received the same balancing exercises as for group A (three times per week for 12 weeks).	Other: Balance training; Balance training exercises treatment: All women in both group (A, B) received balance training exercises on balance ball, half ball and balance board exercises three times per week for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSI	TThe BBS measures, in degrees, the tilt about each axis during dynamic conditions and calculates a medial-lateral stability index (MLSI), anterior-posterior stability index (APSI), and an overall stability index (OSI). The OSI score is believed to be the best indicator of the overall ability.	pre and after 3 months of intervention

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: diabetes; quality of life; postmenopausal; balance; whole body vibration
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: Cairo university Faculty of PT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No