Resistance Training in Patients With Morbid Obesity (ExinMO)
16 de abril de 2019 actualizado por: Universidad de Los Lagos
Preventing Metabolic Syndrome in Patients With Morbid Obesity by Resistance Training: Reporting Non-responder Prevalence
The researchers will conduct a study for avoiding the metabolic syndrome in morbid obese patients.
Thus, the aim of the present will be determine the effects of a resistance training programme (RT) in preventing or attenuating metabolic syndrome (MetS) in patients with morbid obesity.
A second aim will be report the prevalence of non-responders in terms of improvements in MetS markers and other co-variables considered.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The prevalence of metabolic syndrome (MetS) and cardiovascular disease is expected to rise along with the global obesity epidemic. MetS is a cluster of clinical risk factors, including abdominal (visceral) obesity, hypertension, elevated serum triglycerides, low serum high-density lipoprotein (HDL) and hyperglycaemia.The MetS for example, significantly decreases the life expectancy of individuals with morbid obesity and increases the disease burden and economic costs associated with healthcare. In this sense, more recently, there was reported that body mass index (BMI) and fat distribution showed higher associations with inflammation, fat indices, and more prevalence of MetS in morbidly obese subjects, claiming for an early prevention of the MetS in the morbid obese state.
Exercise training has proven to be effective in inducing a clinically significant weight loss and reducing cardiovascular risk. Exercise have reported to be associated with increased muscle mass, decreased body fat, and improved metabolic profile (i.e., improved glucose control and lipid levels). In addition, supervised RT improved muscle strength and functional capacity in patients with obesity undergoing bariatric surgery. However, although RT has been widely studied in obesity, there is little information in the morbid obesity. On the other hand, there is poor knowledge similarly, about the interindividual variability to exercise training in terms of responders and non-responders (NR). Thus, considering the poor knowledge about the MetS prevention in morbid obese patients, as well as the little information about Responders and Non-Responders for improving MetS outcomes, the aim of this study will be determine the effects of a RT program on cardio-metabolic outcomes of MetS in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of the effects of resistance training on MetS markers and other health-related variables.
Tipo de estudio
Intervencionista
Inscripción (Actual)
39
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Llanquihue
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Osorno, Llanquihue, Chile, 5290000
- Cristian ALvarez
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
Inclusion Criteria:
- Older than 18 and younger and ≤65 years of age.
- With risk factors to Metabolic syndrome
- With obesity and morbid obesity condition
- Medical authorization by a physician.
Exclusion Criteria:
- Physical limitations (e.g., restricting injuries of the musculoskeletal system, or dependent of a third person).
- Exercise-related dyspnoea or respiratory alterations.
- Chronic heart disease with any worsening in the last month.
- Adherence rate of less than 80% of the total interventions.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Active comparator
Control group with obesity under Resistant Training
|
The 20-week RT program will consist of three sessions per week, each lasting for 1 hour that will be applied to both control obese (CG) and morbid obese (MO) group.
All sessions will start with 15 minutes warm-up with continuous walking and joint mobility and flexibility exercises, 5 minutes of cool down and stretching, in order for preventing injuries.
Sessions will include 4 to 8 RT exercises targeting different muscle groups; 1. forearm, 2. knee flexors and 3. extensors, 3. trunk, 4. chest, 5. shoulder elevators, 6. horizontal shoulder flexors and 7. extensors, and 8. plantar flexors.
The exercises for each muscle group will be performed in 3 sets of as many repetitions (continuous concentric/eccentric voluntary contraction) possible in 1 minute followed by 2.0 minutes of passive recovery.
Before the RT program, each participant will be measure using the subjective modified Borg scale (1-10 points), in order of identifying the muscle failure into 1 minute of exercise.
Otros nombres:
|
|
Experimental: Experimental group with morbid obesity
Experimental group with morbid obesity under Resistant Training
|
The 20-week RT program will consist of three sessions per week, each lasting for 1 hour that will be applied to both control obese (CG) and morbid obese (MO) group.
All sessions will start with 15 minutes warm-up with continuous walking and joint mobility and flexibility exercises, 5 minutes of cool down and stretching, in order for preventing injuries.
Sessions will include 4 to 8 RT exercises targeting different muscle groups; 1. forearm, 2. knee flexors and 3. extensors, 3. trunk, 4. chest, 5. shoulder elevators, 6. horizontal shoulder flexors and 7. extensors, and 8. plantar flexors.
The exercises for each muscle group will be performed in 3 sets of as many repetitions (continuous concentric/eccentric voluntary contraction) possible in 1 minute followed by 2.0 minutes of passive recovery.
Before the RT program, each participant will be measure using the subjective modified Borg scale (1-10 points), in order of identifying the muscle failure into 1 minute of exercise.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fasting glucose
Periodo de tiempo: Change from Baseline Fasting glucose at 20-weeks of Resistant Training
|
Component of the Metabolic Syndrome
|
Change from Baseline Fasting glucose at 20-weeks of Resistant Training
|
|
High density lipoprotein
Periodo de tiempo: Change from Baseline High density lipoprotein at 20-weeks of Resistant Training
|
Component of the Metabolic Syndrome
|
Change from Baseline High density lipoprotein at 20-weeks of Resistant Training
|
|
Systolic blood pressure and diastolic blood pressure
Periodo de tiempo: from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training
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Component of the Metabolic Syndrome
|
from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training
|
|
Waist circumference
Periodo de tiempo: Change from Baseline Waist circumference at 20-weeks of Resistant Training
|
Component of the Metabolic Syndrome
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Change from Baseline Waist circumference at 20-weeks of Resistant Training
|
|
Triglycerides
Periodo de tiempo: Change from Baseline Triglycerides at 20-weeks of Resistant Training
|
Component of the Metabolic Syndrome
|
Change from Baseline Triglycerides at 20-weeks of Resistant Training
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body mass index
Periodo de tiempo: Change from Baseline Body mass index at 20-weeks of Resistant Training
|
Anthropometric
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Change from Baseline Body mass index at 20-weeks of Resistant Training
|
|
Body mass
Periodo de tiempo: Change from Baseline Body mass at 20-weeks of Resistant Training
|
Anthropometric
|
Change from Baseline Body mass at 20-weeks of Resistant Training
|
|
Total cholesterol
Periodo de tiempo: Change from Baseline Total cholesterol at 20-weeks of Resistant Training
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Measured by plasma sample
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Change from Baseline Total cholesterol at 20-weeks of Resistant Training
|
|
Low density lipoprotein
Periodo de tiempo: Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training
|
Measured by plasma sample
|
Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training
|
|
Six minutes walking test
Periodo de tiempo: Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training
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Endurance performance
|
Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training
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One maximum repetition of biceps curl
Periodo de tiempo: Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training
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Strength Performance
|
Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training
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|
Handgrip muscle strength
Periodo de tiempo: Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training
|
Muscle strength
|
Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Cristian ALvarez, PhD, Universidad de Los Lagos
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2018
Finalización primaria (Actual)
4 de abril de 2018
Finalización del estudio (Actual)
30 de abril de 2018
Fechas de registro del estudio
Enviado por primera vez
8 de abril de 2019
Primero enviado que cumplió con los criterios de control de calidad
16 de abril de 2019
Publicado por primera vez (Actual)
19 de abril de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
16 de abril de 2019
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RP08042019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
The participants information will be available by e-mail according with researchers requirements.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .