Clinical trial NCT06937008: Effect Whole Body Vibration on Balance in Post Diabetic Menopause Women
Official title: Effect of Whole Body Vibration on Balance in Post Menopause Diabetic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Postmenopausal Women
Keywords: balance
quality of life
whole body vibration
diabetes
postmenopausal
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: OSI
timeFrame: pre and after 3 months of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Haven Police and El Bagour specialized Hospitals
Study officials:
References: