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Completed

NCT Number: NCT06937008

Effect Whole Body Vibration on Balance in Post Diabetic Menopause 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.

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Key information

Conditions

Diabetic Peripheral Neuropathy Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Postmenopausal Women

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Haven Police and El Bagour specialized Hospitals

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole body vibration

Other

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

Balance training

Other

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

Primary outcomes

  1. OSI

    Time frame: pre and after 3 months of intervention

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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