Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

Effects of Whole-Body Vibration Training on Ankle Muscle Activation and Functional Performance in Adults With Obesity With and Without Type 2 Diabetes

This study will examine changes in ankle muscle activity and functional performance following whole-body vibration training in women with obesity, with and without type 2 diabetes. It will also compare the responses to training between these two groups.

Participants will attend supervised training twice a week for eight weeks. During training, they will perform exercises on a platform that produces mechanical vibrations. The exercises will progress gradually and will be adapted to each participant's abilities and tolerance. Each session will include warm-up and cool-down exercises.

Before and after the training program, researchers will assess muscle activity during normal walking, heel-to-toe walking, and standing with one foot directly in front of the other. Small sensors placed on the skin will record activity from three muscles around each ankle. Walking and functional performance will also be assessed.

The study aims to help researchers understand whether women with obesity with and without type 2 diabetes show different changes in muscle activity and functional performance after the same training program.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Whole-Body Vibration Training

Detailed Description

This study will be conducted at Pamukkale University to investigate responses to an eight-week whole-body vibration training program in women with obesity, with and without type 2 diabetes. The study will evaluate changes from baseline to the end of training and compare these changes between groups defined by diabetes status.

The neuromuscular assessment will include bilateral recordings from the tibialis anterior, soleus, and medial gastrocnemius muscles. Evaluating both ankle dorsiflexors and plantar flexors during walking and balance tasks will provide information about muscle activation under different functional demands.

Surface electromyography will be recorded using a wireless, multichannel system during level walking, tandem walking, and tandem standing. Electrode placement, skin preparation, testing positions, rest intervals, and signal processing procedures will be standardized. Muscle activation amplitudes will be normalized to muscle- and side-specific maximal voluntary isometric contraction reference values. Three valid trials will be obtained for each functional task.

Whole-body vibration training will be delivered using a side-alternating platform under physiotherapist supervision, twice weekly for eight weeks. The program will progress through three stages covering weeks 1-2, 3-5, and 6-8. Exercise-specific vibration settings and application durations will follow the approved protocol. Exercise position, range of motion, support, and rest periods will be adapted to the participant's functional capacity and tolerance within the protocol limits. Sessions will include walking for warm-up and mat-based exercises for cool-down.

The Borg 6-20 Rating of Perceived Exertion scale will be administered at the end of each session to monitor overall perceived effort and guide subsequent exercise adjustments. Attendance, individual adaptations, and any adverse events will be recorded.

Assessments will be performed before and after the eight-week intervention. Five individuals previously participated in preliminary procedures to refine the assessment and intervention protocols. These individuals were not enrolled in the main study, and their data will not be included in the main study analysis.

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

Contacts and Locations

• Study Contact: Name: Ummuhan Baş Aslan, Prof.; Phone Number: +902582964295; Email: umbaslan@pau.edu.tr

Study Locations

• Turkey (Türkiye)
  • Denizli, Turkey (Türkiye)
    • Recruiting
    • Pamukkale University, Faculty of Physiotherapy and Rehabilitation
    • Contact: Raziye Şavkın, Assoc. Prof.; Phone Number: +902582964253; Email: raziyesavkin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female.
• Aged 18 to 65 years.
• Body mass index (BMI) ≥30 kg/m².
• Willing to participate and provide informed consent.
• For Group 1: Presence of type 2 diabetes mellitus.
• For Group 2: Absence of type 2 diabetes mellitus.

Exclusion Criteria:

• Cardiopulmonary, orthopedic, or neurological conditions that prevent participation in physical activity.
• Congenital musculoskeletal deformities.
• Cognitive impairment that prevents effective communication.
• Presence of osteoporosis or osteopenia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole-Body Vibration Training in Women With Obesity and Type 2 Diabetes; Women with obesity and type 2 diabetes will receive supervised whole-body vibration training twice weekly for eight weeks, totaling 16 sessions. Training will be delivered using a side-alternating vibration platform and will progress through three stages: weeks 1-2, 3-5, and 6-8. Each session will include a walking warm-up, platform-based exercises, and mat-based cool-down exercises. Exercises will be adapted to participants' functional capacity and tolerance within the protocol limits. Perceived exertion will be recorded using the Borg 6-20 scale after each session. Assessments will be performed before and after the intervention.	Device: Whole-Body Vibration Training; Supervised whole-body vibration training will be delivered using a Hypervibe G14 Home V3 side-alternating platform twice weekly for eight weeks (16 sessions). The program comprises three stages: weeks 1-2, 3-5, and 6-8. Exercise-specific frequencies range from 6 to 30 Hz. Planned active vibration exposure per session is 12 minutes, 10.5 minutes, and 15.5 minutes across the three stages, respectively. Sessions include a 5-minute walking warm-up, platform-based exercises and vibration massage, followed by mat-based cool-down exercises. Exercise position, range of motion, support, duration, and rest will be adapted to participant tolerance within protocol limits. Borg 6-20 ratings will be recorded after each session, with a target perceived exertion of 12-14 guiding subsequent adjustments. Both groups will receive the same protocol.
Experimental: Whole-Body Vibration Training in Women With Obesity Without Type 2 Diabetes; Women with obesity without type 2 diabetes will receive the same supervised whole-body vibration training program as participants with type 2 diabetes, twice weekly for eight weeks, totaling 16 sessions. Training will be delivered using a side-alternating vibration platform and will progress through three stages: weeks 1-2, 3-5, and 6-8. Each session will include a walking warm-up, platform-based exercises, and mat-based cool-down exercises. Exercises will be adapted to participants' functional capacity and tolerance within the protocol limits. Perceived exertion will be recorded using the Borg 6-20 scale after each session. Assessments will be performed before and after the intervention.	Device: Whole-Body Vibration Training; Supervised whole-body vibration training will be delivered using a Hypervibe G14 Home V3 side-alternating platform twice weekly for eight weeks (16 sessions). The program comprises three stages: weeks 1-2, 3-5, and 6-8. Exercise-specific frequencies range from 6 to 30 Hz. Planned active vibration exposure per session is 12 minutes, 10.5 minutes, and 15.5 minutes across the three stages, respectively. Sessions include a 5-minute walking warm-up, platform-based exercises and vibration massage, followed by mat-based cool-down exercises. Exercise position, range of motion, support, duration, and rest will be adapted to participant tolerance within protocol limits. Borg 6-20 ratings will be recorded after each session, with a target perceived exertion of 12-14 guiding subsequent adjustments. Both groups will receive the same protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Tibialis Anterior Muscle Activation	Bilateral tibialis anterior muscle activation will be measured using surface electromyography during level walking, tandem walking, and tandem standing. Root mean square (RMS) amplitudes will be normalized to the corresponding muscle- and side-specific maximal voluntary isometric contraction (MVIC) reference and expressed as %MVIC. For each side and task, both mean and maximum normalized RMS amplitudes will be calculated for each valid trial and averaged separately across three valid trials. Mean and maximum amplitudes will be analyzed separately; no composite score will be calculated. Changes will be calculated as the post-intervention value minus the corresponding baseline value and expressed in percentage points of MVIC. Right and left sides and the three tasks will be evaluated separately.	Baseline and after completion of the 8-week intervention
Change in Soleus Muscle Activation	Bilateral soleus muscle activation will be measured using surface electromyography during level walking, tandem walking, and tandem standing. Root mean square (RMS) amplitudes will be normalized to the corresponding muscle- and side-specific maximal voluntary isometric contraction (MVIC) reference and expressed as %MVIC. For each side and task, both mean and maximum normalized RMS amplitudes will be calculated for each valid trial and averaged separately across three valid trials. Mean and maximum amplitudes will be analyzed separately; no composite score will be calculated. Changes will be calculated as the post-intervention value minus the corresponding baseline value and expressed in percentage points of MVIC. Right and left sides and the three tasks will be evaluated separately.	Baseline and after completion of the 8-week intervention
Change in Medial Gastrocnemius Muscle Activation	Bilateral medial gastrocnemius muscle activation will be measured using surface electromyography during level walking, tandem walking, and tandem standing. Root mean square (RMS) amplitudes will be normalized to the corresponding muscle- and side-specific maximal voluntary isometric contraction (MVIC) reference and expressed as %MVIC. For each side and task, both mean and maximum normalized RMS amplitudes will be calculated for each valid trial and averaged separately across three valid trials. Mean and maximum amplitudes will be analyzed separately; no composite score will be calculated. Changes will be calculated as the post-intervention value minus the corresponding baseline value and expressed in percentage points of MVIC. Right and left sides and the three tasks will be evaluated separately.	Baseline and after completion of the 8-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Michigan Neuropathy Screening Instrument Questionnaire Score	Neuropathic symptoms will be assessed using the questionnaire section of the Michigan Neuropathy Screening Instrument in women with obesity, with and without type 2 diabetes. The questionnaire contains 15 yes/no items, of which 13 contribute to the total score. Scores range from 0 to 13, with higher scores indicating more neuropathic symptoms. Change will be calculated as the post-intervention score minus the baseline score. Negative changes indicate fewer reported symptoms.	Baseline and after completion of the 8-week intervention
Change in Michigan Neuropathy Screening Instrument Physical Examination Score	Peripheral neuropathy signs will be assessed using the physical examination section of the Michigan Neuropathy Screening Instrument in women with obesity, with and without type 2 diabetes. Both feet will be examined for abnormal appearance, ulceration, ankle reflexes, vibration perception at the great toe, and monofilament sensation. The total score ranges from 0 to 10, with higher scores indicating more abnormal findings. Change will be calculated as the post-intervention score minus the baseline score. Negative changes indicate fewer clinical signs of neuropathy.	Baseline and after completion of the 8-week intervention
Change in Timed Up and Go Test Performance	Functional mobility will be assessed using the Timed Up and Go test. The time required to rise from a chair, walk 3 meters, turn, return to the chair, and sit down will be recorded in seconds. Two trials will be performed at each assessment, and their mean completion time will be used for analysis. Lower values indicate better functional mobility. Change will be calculated as the post-intervention mean time minus the baseline mean time. Negative changes indicate improved performance.	Baseline and after completion of the 8-week intervention
Change in Body Mass Index	Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared and expressed in kg/m². Body weight will be measured using the Tanita BC-418 analyzer. Change will be calculated as post-intervention BMI minus baseline BMI.	Baseline and after completion of the 8-week intervention
Change in Total Body Fat Percentage	Total body fat percentage will be estimated using the Tanita BC-418 segmental bioelectrical impedance analyzer under standardized measurement conditions. Values will be expressed as a percentage of total body weight. Change will be calculated as the post-intervention value minus the baseline value and expressed in percentage points. Negative changes indicate a reduction in body fat percentage.	Baseline and after completion of the 8-week intervention
Change in Total Fat-Free Mass	Total fat-free mass will be estimated using the Tanita BC-418 segmental bioelectrical impedance analyzer under standardized measurement conditions and expressed in kilograms. Fat-free mass includes all non-fat body components and is not equivalent to skeletal muscle mass. Change will be calculated as post-intervention fat-free mass minus baseline fat-free mass.	Baseline and after completion of the 8-week intervention
Change in Segmental Predicted Muscle Mass	Segmental predicted muscle mass will be estimated using the Tanita BC-418 segmental bioelectrical impedance analyzer under standardized measurement conditions. Device-derived estimates will be recorded in kilograms for the right arm, left arm, right leg, left leg, and trunk. Each segment will be evaluated separately. Change will be calculated as the post-intervention value minus the baseline value for each segment.	Baseline and after completion of the 8-week intervention
Change in Body Weight	Body weight will be measured in kilograms using the Tanita BC-418 analyzer under standardized measurement conditions. Change will be calculated as post-intervention weight minus baseline weight. Negative values indicate a reduction in body weight.	Baseline and after completion of the 8-week intervention

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Estimated): November 9, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: November 3, 2026
• First Submitted That Met QC Criteria: November 3, 2026
• First Posted (Actual): November 9, 2026

Study Record Updates

• Last Update Posted (Actual): November 9, 2026
• Last Update Submitted That Met QC Criteria: November 3, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Walking; Postural Balance; Functional Performance; Surface Electromyography; Whole-Body Vibration; Tibialis Anterior; Soleus; Medial Gastrocnemius; Ankle Muscle Activation
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2
• Other Study ID Numbers: E-60116787-020-942958; 2025TAP007 (Other Grant/Funding Number: Pamukkale University Scientific Research Projects Coordination Unit)

Plan for Individual participant data (IPD)

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

IPD Plan Description

There is no current plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No