Effect Whole Body Vibration on Balance in Post Diabetic Menopause Women

NCT ID: NCT06937008

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-28
• Study Completion Date: 2025-01-01

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.

Conditions

Diabetic Peripheral Neuropathy; Postmenopausal Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Whole body vibration

Intervention Type: 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

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

Balance training

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahd Tarek Helmy el Dears

Department of Physical Therapy for Women's Health Faculty of Physical Therapy Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Haven Police and El Bagour specialized Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Cairo university Faculty of PT

Identifier Type: -

Identifier Source: org_study_id