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Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training (HIIT-VA)

19 de mayo de 2022 actualizado por: VA Office of Research and Development
Frailty is a clinical condition of poor physiological reserve that increases risks for adverse health outcomes including falls, hospitalization and mortality. Exercise is beneficial for the prevention and even reversal of frailty, yet participation among older individuals is limited. Short session high intensity interval training (HIIT) is emerging as a promising exercise strategy that achieves performance gains with lower time commitment. The goal of this pilot proposal is to establish the feasibility of HIIT exercise training protocols in 65-85 year old individuals, as well as to demonstrate the ability to detect functional and physiologic benefits. The investigators anticipate the preliminary research findings will lay the foundation for future human clinical studies that will permit us to significantly improve the health of Veterans.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Enhancing functional capacity in older adults with short session high intensity interval training

Frailty is a condition of poor physiological reserve that increases susceptibility to falls, hospitalization, disability and mortality. The incidence of frailty rapidly increases after the age 65, growing from 10% to as many as 50% of those 85 years or older; therefore over 9 million Veterans are either frail or at risk for frailty. Exercise has proven benefits for frailty, yet older adults rarely attain the recommended 150 minutes a week of moderate intensity exercise. High intensity interval training (HIIT) is emerging as an alternative as it delivers similar or better gains than moderate intensity exercise in less time. Recently, the investigators published that a 3-day-a-week, 10-minute HIIT regimen in aged mice not only reduces frailty, but leads to both strength and endurance benefits. In addition, the preliminary data demonstrate significant changes in microRNA (miRNA) profiles. Despite the potential of short session HIIT to improve functional capacity and lead to better adherence, the modality has not been tested in individuals 65-85 years of age, and in particular, frail individuals. The goals of this proposal are to: 1) investigate the feasibility of recruiting and administering short session HIIT to frail, pre-frail, and non-frail older Veterans and 2) to characterize the physical performance benefits and serum microRNA (miRNA) profiles in those participants.

To accomplish these goals the investigators will administer a short session HIIT regimen totaling only 10-minutes, 3-days-a-week for 3 months, using recumbent exercise cycles, to 65-85 year old participants. The investigators will also utilize next generation RNA sequence technology to assess HIIT impacts upon microRNA profiles in serum samples. The investigators anticipate this project will demonstrate the feasibility of administering short session HIIT to older individuals, including vulnerable frail and pre-frail populations as well as demonstrate the ability to collect and analyze serum miRNA profiles. The advantages to this program are the ability to maintain or build muscle mass and improve aerobic conditioning, especially in older patients where frailty and sarcopenia are so prevalent. This pilot project will therefore lay the foundation for future clinical trials that further explore the utility of HIIT to prevent or delay the onset of frailty in larger cohorts, and ultimately lead to the enhancement of functional capacity and quality of life in aging Veteran populations.

Tipo de estudio

Intervencionista

Inscripción (Actual)

43

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

  • Estados Unidos
    • New York
      • Buffalo, New York, Estados Unidos, 14215
        • VA Western New York Healthcare System, Buffalo, NY

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

60 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Male or female
  • Any race
  • Frail, pre-frail, and non-frail
  • Medical clearance for exercise

Exclusion Criteria:

  • Severe co-morbidity (e.g. - CHF (class III), COPD (GOLD stage IV), CKD (stage 3))
  • VAMC SLUMS score 20
  • Physical impairment that prevents use of a recumbent exercise bike

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: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: HIIT intervention
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Conductual: Short session HIIT
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline VO2 Max at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months
VO2 max, also known as maximal oxygen uptake, will be assessed.
baseline and at participant completion, an average of 3 months
Change from baseline in physical activity enjoyment at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months
Physical Activity Enjoyment Scale (PACES) that provides a valid instrument for assessing enjoyment in physical activity. There are 18 subscales, each of which can receive a score from 1 to 7. Therefore the total range of the test spans summed scores from 18 to 126.
baseline and at participant completion, an average of 3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in the SPPB at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months
Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons, including balance, side-by-side/semi-tandem/tandem stands, and gait speed. There are 3 subscales, each of which can receive up to 4 points. Therefore the total range of the test spans summed scores from 1 to 12.
baseline and at participant completion, an average of 3 months
Change from baseline in frailty phenotype at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months

Fried frailty phenotype assessment including: gait speed, grip strength, endurance, activity level, weight loss.

These scales report summed scores of 0 to 5. If gait speed or grip strength (m/sec or kg) falls within the lowest quintile (20%) fof the age and gender adjusted range, then it is given a score of "1". If both questions on the endurance or activity measures are positive then then it is given a score of "1". If weight loss is greater than 5% over the past year, then it is given a score of "1".
baseline and at participant completion, an average of 3 months
Change from baseline in Quality of Life at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). There are 14 subscales with scores of 1 to 5. Therefore the total range of the test spans scores from 14 to 70.
baseline and at participant completion, an average of 3 months
Change from baseline in cognition at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months
VA-SLUMS: VA Saint Louis University Mental Status screen.
baseline and at participant completion, an average of 3 months
Change from baseline in Activities of Daily Living & Instrumental Activities of Daily Living at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months
ADLs: dressing, eating, ambulation, toileting, and hygiene IADLs: shopping, housework, accounting, food preparation, transportation/telephone
baseline and at participant completion, an average of 3 months
Change from baseline in microRNA profiling at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months
Next Generation Sequencing of microRNA species from serum.
baseline and at participant completion, an average of 3 months
serum 25-hydroxy-vitamin D
Periodo de tiempo: baseline
serum 25-hydroxy-vitamin D
baseline
Change from baseline in C-reactive protein level at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months
C-reactive protein
baseline and at participant completion, an average of 3 months
Change from baseline in quadriceps strength at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months
Maximal quadriceps strength. This will be measured with the MicroFET2 dynamometer with a readout in newtons.
baseline and at participant completion, an average of 3 months
Change from baseline in 6 minute walk distance at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months
6 minute walk distance
baseline and at participant completion, an average of 3 months
Change from baseline in FRAIL scale at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months
FRAIL scale: fatiguability, resistance, ambulation, illnesses, loss of weight. If the answers to any of the questions is yes, then given score is "1" with a total survey range of 0 to 5.
baseline and at participant completion, an average of 3 months
Change from baseline in interleukin-6 level at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months
Interleukin-6
baseline and at participant completion, an average of 3 months
Change from baseline in interleukin-10 level at 3 months
Periodo de tiempo: baseline and at participant completion, an average of 3 months
Interleukin-10
baseline and at participant completion, an average of 3 months
fNIRS
Periodo de tiempo: baseline and at participant completion, an average of 3 months
functional near infra-red spectroscopy to analyze muscle blood flow in the quadriceps during VO2max test
baseline and at participant completion, an average of 3 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

VA Office of Research and Development

Colaboradores

Roswell Park Cancer Institute
University at Buffalo
VA Western New York Healthcare System

Investigadores

  • Investigador principal: Bruce R. Troen, MD, VA Western New York Healthcare System, Buffalo, NY

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)

3 de diciembre de 2018

Finalización primaria (Actual)

31 de diciembre de 2021

Finalización del estudio (Anticipado)

31 de diciembre de 2022

Fechas de registro del estudio

Enviado por primera vez

9 de noviembre de 2018

Primero enviado que cumplió con los criterios de control de calidad

20 de noviembre de 2018

Publicado por primera vez (Actual)

21 de noviembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de mayo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

19 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • E2902-P
  • RX002902 (Otro número de subvención/financiamiento: Veteran Affairs)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Sí

Descripción del plan IPD

Thus, the investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (a) a commitment to using the data only for research purposes and not to identify any individual participant; (b) a commitment to securing the data using appropriate computer technology; (c) restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource, and (d) a commitment to destroying or returning the data after analyses are completed. De identified data will be maintained on a VA server and will only be shared via encrypted devices. Co-Investigators will have access to the data collected as part of their aims. Investigators working on the grant will have access to the data through the PI. The data will be monitored routinely to maintain safety and productivity, as well as to assist with research dissemination annually.

Marco de tiempo para compartir IPD

Six months after publication.

Criterios de acceso compartido de IPD

Final data sets will be made available upon specific request and under an authorized Data Use Agreement. This, in addition to the publications being made available via PubMed Central, will enable validation of results by recipients.

Tipo de información de apoyo para compartir IPD

  • Protocolo de estudio
  • Plan de Análisis Estadístico (SAP)
  • Formulario de consentimiento informado (ICF)
  • Informe de estudio clínico (CSR)
  • Código analítico

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

producto fabricado y exportado desde los 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. .

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