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

2026년 11월 3일 업데이트: UMMUHAN BAS ASLAN, Pamukkale University

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

      • Denizli, 터키 (Türkiye)
        • 모병
        • Pamukkale University, Faculty of Physiotherapy and Rehabilitation
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

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.

실험적: 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.

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Tibialis Anterior Muscle Activation
기간: Baseline and after completion of the 8-week intervention

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
기간: Baseline and after completion of the 8-week intervention

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
기간: Baseline and after completion of the 8-week intervention

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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Michigan Neuropathy Screening Instrument Questionnaire Score
기간: Baseline and after completion of the 8-week intervention

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
기간: Baseline and after completion of the 8-week intervention

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
기간: Baseline and after completion of the 8-week intervention

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
기간: Baseline and after completion of the 8-week intervention

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
기간: Baseline and after completion of the 8-week intervention

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
기간: Baseline and after completion of the 8-week intervention

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
기간: Baseline and after completion of the 8-week intervention

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
기간: Baseline and after completion of the 8-week intervention

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 9일

기본 완료 (추정된)

2027년 1월 31일

연구 완료 (추정된)

2027년 1월 31일

연구 등록 날짜

최초 제출

2026년 11월 3일

QC 기준을 충족하는 최초 제출

2026년 11월 3일

처음 게시됨 (실제)

2026년 11월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • E-60116787-020-942958
  • 2025TAP007 (기타 보조금/기금 번호: Pamukkale University Scientific Research Projects Coordination Unit)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

There is no current plan to share individual participant data.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .