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- Ensaio Clínico NCT07924436
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ummuhan Baş Aslan, Prof.
- Número de telefone: +902582964295
- E-mail: umbaslan@pau.edu.tr
Locais de estudo
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Denizli, Turquia (Türkiye)
- Recrutamento
- Pamukkale University, Faculty of Physiotherapy and Rehabilitation
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Contato:
- Raziye Şavkın, Assoc. Prof.
- Número de telefone: +902582964253
- E-mail: raziyesavkin@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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. |
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. |
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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. |
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Tibialis Anterior Muscle Activation
Prazo: Baseline and after completion of the 8-week intervention
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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
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Change in Soleus Muscle Activation
Prazo: Baseline and after completion of the 8-week intervention
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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
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Change in Medial Gastrocnemius Muscle Activation
Prazo: Baseline and after completion of the 8-week intervention
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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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Michigan Neuropathy Screening Instrument Questionnaire Score
Prazo: Baseline and after completion of the 8-week intervention
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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
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Change in Michigan Neuropathy Screening Instrument Physical Examination Score
Prazo: Baseline and after completion of the 8-week intervention
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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
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Change in Timed Up and Go Test Performance
Prazo: Baseline and after completion of the 8-week intervention
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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
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Change in Body Mass Index
Prazo: Baseline and after completion of the 8-week intervention
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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
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Change in Total Body Fat Percentage
Prazo: Baseline and after completion of the 8-week intervention
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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
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Change in Total Fat-Free Mass
Prazo: Baseline and after completion of the 8-week intervention
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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
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Change in Segmental Predicted Muscle Mass
Prazo: Baseline and after completion of the 8-week intervention
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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
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Change in Body Weight
Prazo: Baseline and after completion of the 8-week intervention
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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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Distúrbios Nutricionais
- Doenças Metabólicas
- Supernutrição
- Peso corporal
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Excesso de peso
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Obesidade
- Diabetes Mellitus, Tipo 2
Outros números de identificação do estudo
- E-60116787-020-942958
- 2025TAP007 (Número de outro subsídio/financiamento: Pamukkale University Scientific Research Projects Coordination Unit)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
There is no current plan to share individual participant data.
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