- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02129855
Metabolic Costs of Daily Activities in Older Adults (CHORES-XL)
6 de junio de 2019 actualizado por: University of Florida
The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments.
The project will simultaneously conduct a cross-sectional and a case-control study.
The primary aim will investigate cross-sectional association between older age and the energy expenditure of daily activities by recruiting approximately 25 adults in each of 7 age groups (20-30,30-40,40-50,50-60,60-70,70-80,80+) for a total of 180 individuals.
A secondary aim will investigate the effect of functional impairments on the energy expenditure of daily activities by conducting a case-control study.
An additional 25 older adults with functional impairment will be recruited in each age decade (60-70, 70-80, and 80+ years old) to accomplish this aim.
Additional outcomes will evaluate rating of perceived exertion differences in daily activities.
A tertiary aim will investigate using accelerometers to predict the metabolic costs of daily activities.
Tipo de estudio
De observación
Inscripción (Actual)
269
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
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Florida
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Gainesville, Florida, Estados Unidos, 32611
- UF Institute on Aging Clinical and Translational Research Building
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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
20 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Community dwelling population
Descripción
Inclusion Criteria:
- Age 20+ years old
- Community dwelling adults without significant health issues
- Willingness to undergo all testing procedures
- Weight stable for at least three months
- Able to understand and speak English
Exclusion Criteria:
- Failure to provide informed consent
- A 10% enrollment limit will be applied to avid exercisers in each age decade. Avid exercises will be defined as doing structured exercise 3 or more days per week (e.g. jogging, sports etc., walkers will be permitted in the study). Based on our experience, avid exercisers volunteer for this type of research at a high rate and thus the investigators will limit these individuals to prevent a biased comparison
- Use of walker (use of a cane is permitted)
- Lower extremity amputation
- Develops chest pain or severe shortness of breath during physical stress
- Post-stroke syndrome causing ambulatory deficits (other stroke survivors permitted)
- Pacemaker
- Needs assistance with basic activities of daily living: feeding, dressing, continence, bathing, toileting, and transferring from a bed to a chair or from a chair to walking
- Lives in a nursing home; persons living in assisted or independent housing are not excluded
- For adults over the age of 60: >2 errors on the Short, portable mental status questionnaire administered after written informed consent
- Excessive alcohol or substance abuse within six months or consumption of >14 alcohol drinks/week
- For women who are child-bearing age (up to 62 years of age): pregnant or breast-feeding
- Participation in a structured weight loss program or fad diet in the last month;
- Weight reduction surgery in the past year
- Known neuromuscular disorder (Rhabdomyolysis, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, chronic fatigue syndrome etc.)
- Diagnosed neuropathy that causes pain
- Symptomatic peripheral arterial disease
- Unable to communicate because of severe hearing loss or speech disorder
- Severe visual impairment, which would preclude completion of the assessments
- Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, Multiple Sclerosis, Amyotrophic lateral sclerosis
- Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease; self-reported severe osteoarthritis
- Terminal illness, as determined by the participant
- Severe pulmonary disease, requiring the use of supplemental oxygen or steroid therapy
- Severe cardiac disease, including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- Other significant comorbid disease discovered during medical screening, e.g. renal failure on hemodialysis, psychiatric disorder (e.g. bipolar, schizophrenia); chronic fatigue syndrome etc…
- Liver diseases: chronic hepatitis, an inflammatory disease, or cirrhosis
- Pregnancy. Participants within childbearing age will have a pregnancy test.
- Contraindications to graded exercise testing according to the American Thoracic Society:
- Acute myocardial infarction (<6 months since event)
- Unstable angina
- Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- Syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarction
- Thrombosis of lower extremity
- Suspected dissecting aneurysm
- Uncontrolled asthmas
- Pulmonary edema
- Room air desaturation at rest < 85%
- Respiratory failure
- Acute non cardiopulmonary disorder that may affect exercise performance
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
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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MET value
Periodo de tiempo: Participants will attend up to 4 visits within one month of enrollment to attain these data
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MET value of physical activities defined as the oxygen uptake (VO2 = milliliter• min-1•kg-1) during a steady state rate expressed as a function 3.5 milliliter• min-1•kg-1.
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Participants will attend up to 4 visits within one month of enrollment to attain these data
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Metabolic economy
Periodo de tiempo: Participants will attend up to 4 visits within one month of enrollment to attain these data
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Metabolic economy is the energy expended for a given work rate.
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Participants will attend up to 4 visits within one month of enrollment to attain these data
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Relative metabolic cost to peak energy expenditure
Periodo de tiempo: Participants will attend up to 4 visits within one month of enrollment to attain these data
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Relative metabolic cost is function of peak oxygen consumption
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Participants will attend up to 4 visits within one month of enrollment to attain these data
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Relative metabolic cost to resting energy expenditure
Periodo de tiempo: Participants will attend up to 4 visits within one month of enrollment to attain these data
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Relative metabolic cost as a function of resting
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Participants will attend up to 4 visits within one month of enrollment to attain these data
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rating of perceived exertion
Periodo de tiempo: Participants will attend up to 4 visits within one month of enrollment to attain these data
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Ratings of perceived exertion will be collected during all activities.
Investigators will use the Category Ratio scale-10 scale developed by Borg in 1982.
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Participants will attend up to 4 visits within one month of enrollment to attain these data
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Accelerometer signals to predict of energy expenditure
Periodo de tiempo: Participants will attend up to 4 visits within one month of enrollment to attain these data
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A tertiary outcome is to validate body worn monitors (e.g.
accelerometers) to estimate the type and intensity of activity for accurate estimation of energy expenditure.
A predicted metabolic equivalent value will be estimated for each activity.
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Participants will attend up to 4 visits within one month of enrollment to attain these data
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Todd M Manini, PhD, University of Florida
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.
Enlaces Útiles
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
1 de julio de 2014
Finalización primaria (Actual)
6 de junio de 2019
Finalización del estudio (Actual)
6 de junio de 2019
Fechas de registro del estudio
Enviado por primera vez
28 de febrero de 2014
Primero enviado que cumplió con los criterios de control de calidad
30 de abril de 2014
Publicado por primera vez (Estimar)
2 de mayo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
6 de junio de 2019
Última verificación
1 de junio de 2019
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- IRB201501057-N
- 5R01AG042525-05 (Subvención/contrato del NIH de EE. UU.)
- 087-2013 (Otro identificador: Univeristy of Florida)
- OCR15164 (Otro identificador: University of Florida)
Plan de datos de participantes individuales (IPD)
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INDECISO
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