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Exercise for Adults Diagnosed With Rectal Cancer

6 de marzo de 2020 actualizado por: Jennifer Brunet, University of Ottawa

Exercise for Adults Diagnosed With Rectal Cancer: A Feasibility Study

Currently, there is no clear indication if exercise is safe and if it confers health benefits for adults across the cancer trajectory (i.e., from diagnosis onward) for rectal cancer - a population who may have limited exercise tolerance and who may be at an increased risk for adverse events associated with exercise. In this prospective single-arm feasibility trial, we aim to examine the safety and feasibility of a 12-week exercise intervention for adults diagnosed with rectal cancer to inform the development of a large-scale randomized controlled trial that will assess the efficacy of exercise administered across the cancer trajectory for for rectal cancer. Adults who have been diagnosed with rectal cancer and are currently undergoing or have completed treatment (within the last five years) will be recruited over a 12-month period into a supervised exercise intervention consisting of aerobic and strength training to be done three times per week. Feasibility, safety, patient-reported outcomes, and physical tests will be performed pre-intervention and post-intervention. This study will provide data on the feasibility of an exercise intervention and will help determine if it is safe to progress with a large-scale randomized controlled trial to test the benefits of exercise for adults diagnosed with rectal cancer. It will also provide initial estimates of the parameters for patient-reported outcomes, which are required to calculate the sample size for the large-scale randomized controlled trial to ensure it is sufficiently powered.

The purpose of this prospective single-arm feasibility trial is to determine if a 12-week exercise intervention offered to adults diagnosed with rectal cancer surviviors is safe and feasible.

The specific objectives are to:

  1. Test the feasibility and safety of a 12-week exercise intervention;
  2. Obtain initial estimates of the parameters of the main outcomes to inform sample size calculations for the main study (i.e., means and standard deviations for patient-reported and physical outcomes);
  3. Determine the opportune time in the cancer trajectory for rectal cancer to deliver a 12-week exercise intervention.

Descripción general del estudio

Estado

Retirado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

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

  • Canadá
    • Ontario
      • Ottawa, Ontario, Canadá, K1N 6N5
        • University of Ottawa

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 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion criteria are:

  1. Men and women 18 to 85 years of age;
  2. Diagnosed and/or completed treatment for stage I-III rectal cancer within the last 5 years;
  3. Able to read/understand English or French;
  4. Ambulatory;
  5. Live <50km of the University of Ottawa;
  6. Approval of healthcare provider to participate in the intervention.

Exclusion criteria are:

  1. Congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, uncontrolled angina, uncontrolled arrhythmia, myocardial infarction, major heart surgery, stroke, or pulmonary embolus;
  2. A diagnosis of hypertension or a resting blood pressure of 160/90 mmHg or higher (i.e., systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg);
  3. The use of supplemental oxygen;
  4. Severe arthritis (i.e., osteoarthritis or rheumatoid arthritis);
  5. History of chest pain or severe shortness of breath either at rest or when engaging in physical activity;
  6. Hip fracture, hip or knee replacement in the past 6 months;
  7. Impairments requiring mobility aids;
  8. Stage V cancer;
  9. Prior cancer diagnosis, excluding non-melanoma skin cancer;
  10. Participating in another exercise trial;
  11. Unwilling/unable to give informed consent.

Of note, in addition to the exclusion criteria listed above, for individuals who are about to begin or are undergoing treatment healthcare providers will also employ clinical judgment concerning participant safety; that is, if the healthcare provider judges the patient to be at high risk for adverse events or medical complications if they participate in the intervention given their health status, they will not approach the patient to obtain permission for research personnel from the University of Ottawa to contact them.

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

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Exercise
Participants will be asked to complete a 12-week exercise intervention and all study assessments.
Conductual: Exercise
Participants will engage in supervised exercise 3 times per week for 60-75 minutes/session for 12 weeks. Sessions will include a warm-up (aerobic activity less than < 60% of heart rate reserve), aerobic training (30 minutes of exercise at 60-75% of heart rate reserve, using cycle ergometers/treadmills), strength training (8 exercises; upper body, lower body, and core), and a cool-down (aerobic activity less than < 60% of heart rate reserve) component.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment Rates
Periodo de tiempo: Through study completion, an average of 12 weeks
The number of eligible participants who enrol in the study out of the number who are referred.
Through study completion, an average of 12 weeks
Retention Rates
Periodo de tiempo: Through study completion, an average of 12 weeks
The number of participants completing the intervention and all scheduled assessments.
Through study completion, an average of 12 weeks
Adherence Rates
Periodo de tiempo: Through study completion, an average of 12 weeks
The number of exercise sessions completed out of 36.
Through study completion, an average of 12 weeks
Number of Participants with Adverse Events
Periodo de tiempo: Through study completion, an average of 12 weeks
The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the exercise sessions and/or its assessments.
Through study completion, an average of 12 weeks

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Socio-Demographic and Medical Information Questionnaire
Periodo de tiempo: Baseline (week 0)
The socio-demographic and medical information collected will be used to describe the sample.
Baseline (week 0)
Quality of Life: Functional Assessment of Cancer Therapy - Colorectal (Ward et al., 1999; Yost et al., 2005)
Periodo de tiempo: Baseline (week 0) and post-intervention (week 12)
Change in self-reported quality of life from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Cognitive Functioning: Functional Assessment of Cancer Therapy - Cognitive Function (Wagner et al., 2004)
Periodo de tiempo: Baseline (week 0) and post-intervention (week 12)
Change in self-reported cognitive function from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Symptoms of Fatigue: the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (Yellen et al., 1997)
Periodo de tiempo: Baseline (week 0) and post-intervention (week 12)
Change in self-reported fatigue from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Affect: Positive and Negative Affect Schedule (Watson et al., 1988)
Periodo de tiempo: Baseline (week 0) and post-intervention (week 12)
Change in self-reported affect from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Periodo de tiempo: Baseline (week 0) and post-intervention (week 12)
Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Resting Heart Rate: Heart Rate Monitor (Polar A300)
Periodo de tiempo: Baseline (week 0) and post-intervention (week 12)
Change in resting heart rate from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Blood Pressure: Blood Pressure Monitor (HealthSmart Digital Blood Pressure Monitor)
Periodo de tiempo: Baseline (week 0) and post-intervention (week 12)
Change in resting blood pressure from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Body Mass Index: Tanita Scale (TBF-310 GS)
Periodo de tiempo: Baseline (week 0) and post-intervention (week 12)
Change in body mass index from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Aerobic Capacity: 6-Minute Walk Test (Canadian Society for Exercise Physiology, 2013; Irwin, 2012)
Periodo de tiempo: Baseline (week 0) and post-intervention (week 12)
Change in aerobic capacity (i.e., total distance walked in 6 minutes) from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Musculoskeletal Strength: Combined Grip Strength Using a Handheld Dynamometer (Canadian Society for Exercise Physiology, 2013, 2013; Irwin, 2012)
Periodo de tiempo: Baseline (week 0) and post-intervention (week 12)
Change in musculoskeletal strength (i.e., force exerted in kilograms on the handheld dynamometer) from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)

Colaboradores e Investigadores

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

Patrocinador

University of Ottawa

Investigadores

  • Investigador principal: Jennifer Brunet, PhD, University of Ottawa

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.

Publicaciones Generales

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 noviembre de 2017

Finalización primaria (Actual)

4 de diciembre de 2019

Finalización del estudio (Actual)

4 de diciembre de 2019

Fechas de registro del estudio

Enviado por primera vez

7 de febrero de 2017

Primero enviado que cumplió con los criterios de control de calidad

8 de febrero de 2017

Publicado por primera vez (Estimar)

9 de febrero de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de marzo de 2020

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

6 de marzo de 2020

Última verificación

1 de marzo de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RectalCaEx-JB-MV-KC

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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