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A Feasibility Study of Unsupervised, Pre-operative Exercise Program for Patients Scheduled for Lung Cancer Surgery

4 de marzo de 2019 actualizado por: Kathleen Lyons, Dartmouth-Hitchcock Medical Center

The paradigm of pre-operative exercise as a neoadjuvant therapy to reduce morbidity is increasingly promoted within general surgery and surgical oncology.

Patients with lung cancer participating in pre-operative exercise have better aerobic capacity and pulmonary function and shorter hospital length-of-stay after surgery. Additionally, pre-operative exercise may increase the likelihood of resuming exercise post-surgery, thereby accelerating the pace of rehabilitation and recovery.

In order to translate the research findings into sustainable clinical practice, clinician-scientists need to develop pragmatic and effective home-based exercise protocols. Wearable fitness devices offer a way to approximate the supervision that occurs in exercise research.

Before the investigators can develop an intervention in which patients receive tailored support similar to what occurs with supervised exercise, they need to pilot test the monitoring aspect of the wearable fitness device in conjunction with the pre-operative exercise program. The investigators propose a mixed methods, 16 single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device. The proposed study of 30 patients scheduled for lung cancer surgery will identify the strengths, weaknesses, and utility of this approach.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The investigators propose a parallel mixed methods, 16 single arm, pre-post study with 30 participants scheduled for lung cancer surgery. At time of enrollment (at least 3 weeks before their scheduled surgery), participants will complete baseline assessments, receive the uPEP exercise prescription, and be oriented to the wearable fitness device. A research assistant will call the participant to conduct an audiotaped semi-structured interview regarding the acceptability of the electronically-monitored uPEP within 7- 14 days of enrollment. The study team will complete follow-up assessments on the day of surgery, two weeks after surgery, and four months after surgery. Data will also be collected from chart review and the wearable fitness device throughout the study.

Tipo de estudio

Intervencionista

Inscripción (Actual)

30

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

    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756
        • Dartmouth-Hitchcock Medical Center

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • This study will recruit English-speaking patients who:

    1. Are over the age of 18 and diagnosed with Stage I-III lung cancer;
    2. Are able to tolerate surgery (i.e., segmentectomy, lobectomy or bilobectomy) as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiac evaluation (if indicated);
    3. Access to either Wi-Fi or cellular service and permission/ability to download the wearable fitness device app on an apple device, android, or computer (or willingness to use a study-provided iPod to allow the data to be uploaded to the study team);
    4. Are able to provide voluntary, written consent.

Exclusion Criteria:

  • Participants will be excluded based on electronic health record (EHR) review (after obtaining HIPAA waiver) if they:

    1. Have a life expectancy of < 12 months or are receiving hospice services;
    2. Have a psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideation;
    3. Exhibit American College of Sports Medicine contraindications to exercise which include a resting heart rate of >120bpm, blood pressure >180/100mmHg or unstable angina;31
    4. Are unable to walk or to complete the 6-minute walk test. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe.

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
Otro: single arm
exercise
single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adherence to exercise:
Periodo de tiempo: Time 3, day of surgery
number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log
Time 3, day of surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility of recruitment:
Periodo de tiempo: Time 5, 16 weeks post-surgery
number of patients enrolled divided by number of patients eligible
Time 5, 16 weeks post-surgery
Acceptance of technology
Periodo de tiempo: Time 3, day of surgery
number of hours the fitness tracker was worn in pre-operative period
Time 3, day of surgery
Participant perception of exercise program
Periodo de tiempo: Time 2, 3-5 days before surgery
semi-structured interview regarding perceptions of the exercise program
Time 2, 3-5 days before surgery
Participant perception of fitness tracker
Periodo de tiempo: Time 2, 3-5 days before surgery
semi-structured interview regarding perceptions of the fitness tracker
Time 2, 3-5 days before surgery
Subjective minutes spent in exercise
Periodo de tiempo: Time 3, day of surgery
Number of minutes spent in exercise according to exercise log
Time 3, day of surgery
Objective minutes spent in exercise:
Periodo de tiempo: Time 3, day of surgery
Number of minutes spent in exercise according to fitness tracker
Time 3, day of surgery
Aerobic capacity:
Periodo de tiempo: Time 3, day of surgery
Six minute walk test
Time 3, day of surgery
Pulmonary function:
Periodo de tiempo: Time 2, 3-5 days before surgery
Diffusion of lungs for carbon monoxide test
Time 2, 3-5 days before surgery
Subjective physical function:
Periodo de tiempo: Time 2, 3-5 days before surgery
PROMIS (Patient-Reported Outcomes Measurement Information System) physical function scale
Time 2, 3-5 days before surgery
Objective physical function:
Periodo de tiempo: Time 3, day of surgery
Grip strength per dynamometer
Time 3, day of surgery
Length of stay in hospital:
Periodo de tiempo: Time 4, 2 weeks post-surgery
Number of days from surgery to discharge home
Time 4, 2 weeks post-surgery
Feasibility of Retention
Periodo de tiempo: 16 weeks post-surgery
Number of patients completing all study assessments divided by the number enrolled
16 weeks post-surgery

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Kathleen D Lyons, ScD, Dartmouth-Hitchcock Medical Center
  • Investigador principal: David J Finley, MD, Dartmouth-Hitchcock Medical Center

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)

14 de septiembre de 2017

Finalización primaria (Actual)

5 de febrero de 2019

Finalización del estudio (Actual)

5 de febrero de 2019

Fechas de registro del estudio

Enviado por primera vez

4 de mayo de 2017

Primero enviado que cumplió con los criterios de control de calidad

19 de mayo de 2017

Publicado por primera vez (Actual)

22 de mayo de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de marzo de 2019

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

4 de marzo de 2019

Última verificación

1 de marzo de 2019

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

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. .

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