- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01049698
Improving Muscle for Functional Independence Trial (I'MFIT)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Design Overview:
This is a 5-month randomized trial in 130 older, overweight or obese, sedentary men and women. Phase 1 involves recruitment and screening followed by baseline research testing (Phase 2). Next, subjects will be randomly assigned to one of two 5-month treatments (Phase 3): RT intervention alone (RT) or to an RT with caloric restriction (RT+CR) intervention. Subjects will return for visits the completion of their 5 month intervention. A subset of participants (n=30) will return for an 18 month follow up.
Interventions:
Resistance training+ Caloric Restriction:Participants assigned to RT+CR group will be instructed to follow a hypocaloric diet (-600 kcal/d) for 20 weeks, as well as the resistance training program noted below.In addition, all participants will be provided with a daily calcium (1200 mg/d) and vitamin D (800 IU/d) supplement.The intervention will incorporate meal replacements, nutrition education, and lifestyle behavior modifications.
Resistance training: The maximal weight that can be lifted with correct form in a single repetition (1RM) will be used to prescribe intensity. Strength testing will be repeated every 4 wks and the training loads adjusted so that they are consistent with the 70% 1RM goal. Participants will exercise 3 d/wk on Nautilus resistance machines, under the supervision of two exercise leaders who are trained in basic life support and in emergency management procedures. All exercise will take place at Wake Forest University's Department of Health and Exercise Science Clinical Research Center (CRC). Participants will exercise in small groups which will allow a rotation/rest between machines and enhance the social environment. Heart rate and blood pressure will be measured before and after each session. Subjects will warm-up by walking or cycling for 5 minutes at a slow pace followed by large muscle flexibility exercises. The interventionists will ensure that participants adjust the equipment appropriate to their body size and complete the exercises with correct form. Training sessions will end with a cool-down by walking or cycling for 5 minutes at a slow pace followed by light stretching.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Wake Forest University Health Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- BMI=27-34.9 kg/m2
- No resistance training for past 6 mos
- Normal cognitive function (MMSE >24)
- No contraindications for participation in weight loss or resistance exercise including severe arthritis or musculoskeletal disorders, knee or hip replacement or spinal surgery in past year
- No broken bones in the past 6 months
- Able to provide own transportation to study visits and intervention
- Not involved in any other research study and not undergoing physical therapy
- Not dependent on a cane or walker
Exclusion Criteria:
- Weight loss or gain (±5%) in past 6 months
- Body mass >136 kg (DXA limit)
- Current smoker (No nicotine within past year) or evidence of alcohol or drug abuse
- Insulin dependent or uncontrolled diabetes (FBG >140 mg/dL)
- Uncontrolled hypertension (BP>180/100 mmHg)
- Abnormal kidney function or liver blood tests
- Past or current cardiovascular disease, including uncontrolled angina or dysrhythmia, hypertrophic cardiomyopathy, congestive heart failure, PAD, stroke, history of myocardial infarction, use of defibrillator or major heart surgery, or deep vein thrombosis or pulmonary embolus
- Past or current respiratory disease (requiring steroid treatment or supplemental oxygen)
- Past or current clinical diagnoses of neurological or hematological disease
- Use of any medications that could influence study variables (growth/steroid hormones, prescription anti-inflammatory medications, or beta blockers, Coumadin or any other blood thinner, including Plavix, Ticid, and Aggrenox)
- Cancer requiring treatment in past 2 years, except non-melanoma skin cancers
- Clinically evident edema or anemia
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 1. Resistance Training
3 d/wk resistance training
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3 d/wk resistance training
Otros nombres:
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Experimental: 2. Resistance Training + Diet
Resistance training plus caloric restriction
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3 d/w resistance training plus 600 kcal/d deficit
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Skeletal muscle function (muscle quality and muscle power) and overall physical function (SPPB score)
Periodo de tiempo: 5 month study with baseline and 5 and 18 month follow up assessment visits
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5 month study with baseline and 5 and 18 month follow up assessment visits
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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single-fiber contractile force and power, intramyocellular lipid (IMCL), muscle gene and protein expression of interleukin-6 (IL-6) and tumor necrosis factor alpha.
Periodo de tiempo: baseline and 5 and 18-month follow-up
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baseline and 5 and 18-month follow-up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Barbara J Nicklas, PhD, Wake Forest University Health Sciences
Publicaciones y enlaces útiles
Publicaciones Generales
- Bharadwaj MS, Tyrrell DJ, Leng I, Demons JL, Lyles MF, Carr JJ, Nicklas BJ, Molina AJ. Relationships between mitochondrial content and bioenergetics with obesity, body composition and fat distribution in healthy older adults. BMC Obes. 2015 Oct 6;2:40. doi: 10.1186/s40608-015-0070-4. eCollection 2015.
- Jefferson ME, Nicklas BJ, Chmelo EA, Crotts CI, Shaltout HA, Diz DI, Marsh AP, Brinkley TE. Effects of Resistance Training With and Without Caloric Restriction on Arterial Stiffness in Overweight and Obese Older Adults. Am J Hypertens. 2016 Apr;29(4):494-500. doi: 10.1093/ajh/hpv139. Epub 2015 Aug 20.
- Nicklas BJ, Chmelo E, Delbono O, Carr JJ, Lyles MF, Marsh AP. Effects of resistance training with and without caloric restriction on physical function and mobility in overweight and obese older adults: a randomized controlled trial. Am J Clin Nutr. 2015 May;101(5):991-9. doi: 10.3945/ajcn.114.105270. Epub 2015 Mar 11.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00009098
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .
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