Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women
9 de setembro de 2021 atualizado por: Agustín Aibar Almazán, University of Jaén
Effects of a Program of Pilates Exercises on Obesity, Sarcopenic, Risk of Falls and Health in Spanish Postmenopausal Women
To analyze the effects of a Pilates exercise program on obesity, sarcopenic, risk of falls and health in Spanish postmenopausal women.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.
The study will define two groups:
- A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
- An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.
Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.
Tipo de estudo
Intervencional
Inscrição (Real)
107
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Jaén, Espanha, 23002
- Center of active participation of seniors of Jaén "Catedral"
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
50 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- No menstrual activity for at least 12 months.
- Present obesity and / or sarcopenic.
- Do not participate in a weight loss program.
- Be able to understand the instructions, programs and protocols of this project.
Exclusion Criteria:
- Contraindications for conducting physical tests.
- Diseases that limit the static and dynamic balance and physical activity. -
- Central or peripheral vestibular or nerve alterations.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Grupo pilates
Este grupo recebe treinamento físico baseado em exercícios de pilates
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Training based on a basic level Pilates exercise program will be as follows: A duration of weeks with a frequency of 2 sessions a week and with a duration of 55 minutes each. The exercises to be performed will be divided into three distinct phases: warm-up, lasting 15 minutes; Main part with a duration of 30 minutes and the return to calm, based mostly on stretching and with a duration of 10 minutes. The repetitions of the exercises will be between 5 and 10 according to the difficulty. |
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Sem intervenção: Nenhum grupo de intervenção
Este grupo não recebe nenhum tratamento
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Massa Muscular Esquelética (kg)
Prazo: No início e aos três meses
|
É calculado com base na massa muscular dos membros, que é quase composta por músculo esquelético e ocupa cerca de 70% do músculo esquelético total do corpo
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No início e aos três meses
|
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TUG (teste Timed Up and Go)
Prazo: No início e aos três meses
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É um teste simples usado para avaliar a mobilidade e a função física de uma pessoa
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No início e aos três meses
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X significa
Prazo: No início e aos três meses
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Valor médio das oscilações laterais do Centro de Pressão
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No início e aos três meses
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Y quer dizer
Prazo: No início e aos três meses
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Valor médio das oscilações ântero-posteriores do Centro de Pressão
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No início e aos três meses
|
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Dynamometer
Prazo: At the beginning and at three months
|
Dynamometer will be employed to assess hand grip stregth.
|
At the beginning and at three months
|
|
ABC-16 (Activities Specific Balance Confidence Scale)
Prazo: At the beginning and at three months
|
Questionnaire that assesses balance confidence in performing activities of daily living.
|
At the beginning and at three months
|
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FES-I (Falls Efficacy Scale-International)
Prazo: At the beginning and at three months
|
Questionnaire that evaluates the fear of falling.
|
At the beginning and at three months
|
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Barthel index
Prazo: At the beginning and at three months
|
Measures disability or dependence in activities of daily living
|
At the beginning and at three months
|
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KATZ INDEX
Prazo: At the beginning and at three months
|
Is a widely used tool to assess the level of independency in older adults.
|
At the beginning and at three months
|
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FSS (Fatigue Severity Scale)
Prazo: At the beginning and at three months
|
A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living.
|
At the beginning and at three months
|
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PSQI (Pittsburgh Sleep Quality Index)
Prazo: At the beginning and at three months
|
A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.
|
At the beginning and at three months
|
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HADS (The Hospital Anxiety And Depression)
Prazo: At the beginning and at three months
|
A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non- patients.
|
At the beginning and at three months
|
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SF-36 (The Short Form-36 Health Survey)
Prazo: At the beginning and at three months
|
Used extensively for assessing health-related quality of life.
|
At the beginning and at three months
|
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MRS (Menopause Rating Scale):
Prazo: At the beginning and at three months
|
Assesses the severity of menopause-related complaints and the impact on health-related quality of life.
|
At the beginning and at three months
|
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FSFI (Female Sexual Function Index)
Prazo: At the beginning and at three months
|
Is a brief questionnaire that evaluates sexual functioning in women.
|
At the beginning and at three months
|
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INBODY
Prazo: At the beginning and at three months
|
Valid and reliable tool to quantify and measure the 4 major components of body composition: Water, Protein, Minerals and Fat.
|
At the beginning and at three months
|
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Bone Mineral Content (BMC)
Prazo: At the beginning and at three months
|
Is mineral mass in bone.
|
At the beginning and at three months
|
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Body Weight
Prazo: At the beginning and at three months
|
Is the sum of Body Fat and Fat Free Mass.
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At the beginning and at three months
|
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Lean Body Mass
Prazo: At the beginning and at three months
|
The amount of lean body mass.
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At the beginning and at three months
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Body Fat Mass
Prazo: At the beginning and at three months
|
The standard range of Body Fat Mass is ascertained by calculating an examinee Body Fat Mass as compared to the standard weight and standard Body Fat Mass.
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At the beginning and at three months
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Percent of Body Fat (%)
Prazo: At the beginning and at three months
|
Indicates the percentage of body fat to body weight.
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At the beginning and at three months
|
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BMI (Body Mass Index)
Prazo: At the beginning and at three months
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Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2.
It is a rough indicator of total body fat.
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At the beginning and at three months
|
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Segmental Analysis
Prazo: At the beginning and at three months
|
Is the technology that assumes the body as five cylinders of four limbs and trunk and measures the impedance of these parts separately.
Segmental body composition analysis provides segmental measurement of body water, muscle mass, and fat free mass.
|
At the beginning and at three months
|
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OPTOGAIT
Prazo: At the beginning and at three months
|
Is an innovative system for movement analysis and functional assessment of patients with normal or pathological conditions.
REACTION TEST: This test detects the time between one optical/acoustic impulse and the patient's movement.
It can be used to measure simple reactions or more complex movements
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At the beginning and at three months
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CT10P
Prazo: At the beginning and at three months
|
Test that evaluates the balance by walking along a straight line.
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At the beginning and at three months
|
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STABILOMETRIC PLATFORM
Prazo: At the beginning and at three months
|
Instrument composed of resistive pressure sensors, used to measure the static or postural balance.
The test was performed under both eyes-open and eyes-closed conditions.
|
At the beginning and at three months
|
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RMS X
Prazo: At the beginning and at three months
|
Mean position of the center of pressure in the mediolateral plane.
|
At the beginning and at three months
|
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RMS Y
Prazo: At the beginning and at three months
|
Mean position of the center of pressure in the anteroposterior plane
|
At the beginning and at three months
|
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Length
Prazo: At the beginning and at three months
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Length of the path described by the center of pressure.
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At the beginning and at three months
|
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Area
Prazo: At the beginning and at three months
|
Area of the path described by the center of pressure.
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At the beginning and at three months
|
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Velocity
Prazo: At the beginning and at three months
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Is an estimate of the average velocity of displacement of the center of pressures of the subject during the whole test.
|
At the beginning and at three months
|
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Isaac test
Prazo: At the beginning and at three months
|
Questionnaire that measures verbal fluency.
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At the beginning and at three months
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trail making test part a y b
Prazo: At the beginning and at three months
|
Neuropsychological test of visual attention and task switching.
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At the beginning and at three months
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mmse (mini-mental state examination)
Prazo: At the beginning and at three months
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A tool that can be used to systematically and thoroughly assess mental status.
|
At the beginning and at three months
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chair sit and reach test
Prazo: At the beginning and at three months
|
To test low back and hamstring flexibility.
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At the beginning and at three months
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back scratch test
Prazo: At the beginning and at three months
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To measure general shoulder range of motion.
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At the beginning and at three months
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30-second chair stand test
Prazo: At the beginning and at three months
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To test leg strength and endurance.
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At the beginning and at three months
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height
Prazo: At the beginning and at three months
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The distance between the lowest and highest points of a person standing upright.
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At the beginning and at three months
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waist circumference
Prazo: At the beginning and at three months
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Is used to assess central fat distribution and degree of abdominal obesity.
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At the beginning and at three months
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hip circumference
Prazo: At the beginning and at three months
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It is the greatest circumference of hip
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At the beginning and at three months
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waist-to-hip ratio
Prazo: At the beginning and at three months
|
Is the dimensionless ratio of the circumference of the waist to that of the hips.
This is calculated as waist measurement divided by hip measurement.
|
At the beginning and at three months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de agosto de 2017
Conclusão Primária (Real)
1 de novembro de 2017
Conclusão do estudo (Real)
27 de fevereiro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
22 de junho de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de junho de 2017
Primeira postagem (Real)
28 de junho de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de setembro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de setembro de 2021
Última verificação
1 de setembro de 2021
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UJaen
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .