- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07806682
The Effects of Low Intensity Endurance Exercise on Improving Mitochondrial Function, Cell Bioelectrical Impedance Phase Angle, Fatigue and Quality of Life in Lung Cancer Patients With Cancer-related Fatigue
To conduct a randomized controlled trial (RCT) targeting lung cancer patients with cancer-related fatigue to achieve the following objectives:
Objective 1: To investigate whether a low-intensity endurance exercise intervention can effectively improve mitochondrial DNA content, mitochondrial function, mitochondrial oxidative phosphorylation complex enzyme concentrations, cellular bioelectrical impedance phase angle, cancer-related fatigue, and quality of life in lung cancer patients with cancer-related fatigue.
Objective 2: To explore whether the low-intensity endurance exercise intervention improves cancer-related fatigue and quality of life in lung cancer patients through direct or indirect effects by modulating mitochondrial DNA content, mitochondrial function, mitochondrial oxidative phosphorylation complex enzyme concentrations, and cellular bioelectrical impedance phase angle.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
After enrollment, subjects will be randomly assigned to three groups:
- Control Group: No exercise intervention will be implemented. Subjects will maintain their usual lifestyle and daily activities.
- Low-Intensity Endurance Continuous Training Group (Level 2 low-intensity continuous endurance exercise): Subjects will perform Level 2 low-intensity endurance exercise training for at least 30 continuous minutes per day, at least 5 days per week (75-80% peak heart rate [HR peak], Rating of Perceived Exertion [RPE] 11-12; the exerciser perceives the exertion as light, but breathing sounds increase, and they can comfortably hold a conversation during exercise but need to pause occasionally for breath). This continuous low-intensity endurance training will last for 12 consecutive weeks. Each exercise session will begin with a 5-minute warm-up, followed by 30 minutes of continuous low-intensity endurance exercise, and conclude with a gradual 10-minute cool-down until completely stopping.
- Low-Intensity Endurance Interval Training Group (Alternating 3 minutes of Level 2 low-intensity endurance exercise and 3 minutes of Level 1 lowest-intensity endurance exercise, for a total of 5 alternating cycles): Subjects will perform alternating Level 2 and Level 1 (65-75% HR peak, RPE <11; the exerciser perceives the exertion as very light) exercise training for at least 30 continuous minutes per day, at least 5 days per week. This low-intensity endurance interval training will last for 12 consecutive weeks. Each exercise session will begin with a 5-minute warm-up, followed by 30 minutes of low-intensity endurance interval training, and conclude with a gradual 10-minute cool-down until completely stopping.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hsiu Ting Tsai, PhD
- Número de teléfono: 6330 886227361661
- Correo electrónico: hsiuting@tmu.edu.tw
Copia de seguridad de contactos de estudio
- Nombre: Hsin-Hui Huang, Master's degree
- Número de teléfono: 6330 886227361661
- Correo electrónico: d432113014@tmu.edu.tw
Ubicaciones de estudio
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Taipei, Taiwán
- Reclutamiento
- Taipei Medical University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients who are diagnosed with lung cancer by a physician ;
- Patients aged 20-70 years;
- Patients who are determined by a physician, after assessment of their physical condition, to be suitable for exercise;
- Patients who have graduated from elementary school or above.
Exclusion Criteria:
- Patients who are unable to communicate in Mandarin, Taiwanese, or Hakka;
- Patients who are determined by a physician to be physically unsuitable for performing any exercise.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control Group
No exercise intervention will be implemented, and participants will carry out their daily activities according to their previous lifestyle habits.
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Experimental: Continuous Training Group
Level 2 low-intensity continuous endurance exercise: Participants will perform Level 2 low-intensity endurance exercise training continuously for at least 30 minutes per day, at least 5 days per week, for 12 consecutive weeks.
The exercise intensity will be 75-80% of peak heart rate, with a rating of perceived exertion of 11-12.
At this intensity, participants will perceive the exercise as easy, but their breathing sound will increase; they will be able to converse comfortably during exercise but may occasionally need to pause for breath
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Participants perform continuous low-intensity endurance exercise for 30 minutes per day, 5 days per week, for 12 weeks at 75%-80% peak heart rate and RPE 11-12.
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Experimental: Intermittent Training Group
Participants will perform alternating training consisting of 3 minutes of Level 2 low-intensity endurance exercise and 3 minutes of Level 1 minimal-intensity endurance exercise, for a total of 5 alternating cycles.
The training will be performed continuously for at least 30 minutes per day, at least 5 days per week, for 12 consecutive weeks.
Level 1 exercise intensity will be 65-75% of peak heart rate, with a rating of perceived exertion below 11, indicating that participants perceive the exercise as very easy.
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Participants perform alternating low-intensity endurance training consisting of 3-minute Level 2 exercise and 3-minute Level 1 exercise for 30 minutes per day, 5 days per week, for 12 weeks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in Cancer-Related Fatigue (CRF)
Periodo de tiempo: Baseline, Week 6, and Week 12
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Evaluated by the Brief Fatigue Inventory-Taiwan (BFI-T).
The total score ranges from 0 to 90, with higher scores indicating greater fatigue severity and interference with daily life.
Higher scores indicate greater fatigue severity.
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Baseline, Week 6, and Week 12
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Change from baseline in mitochondrial oxidative phosphorylation complex enzyme concentrations
Periodo de tiempo: Baseline, Week 6, and Week 12
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Concentrations of mitochondrial complex enzymes (Complex I-V) determined via ELISA at an absorbance wavelength of 600 nm.
Expressed in ng/mL
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Baseline, Week 6, and Week 12
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Change from baseline in Quality of Life (QoL)
Periodo de tiempo: Baseline, Week 6, and Week 12
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Evaluated using the Functional Assessment of Cancer Therapy-General; FACT-G.
The scale comprises four subscales: (1) Physical Well-Being (PWB): 7 items, score range 0-28; (2) Social/Family Well-Being (SWB): 7 items, score range 0-28; (3) Emotional Well-Being (EWB): 6 items, score range 0-24; and (4) Functional Well-Being (FWB): 7 items, score range 0-28.
Higher scores indicate better quality of life
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Baseline, Week 6, and Week 12
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Change from baseline in phase angle and skeletal muscle mass
Periodo de tiempo: Baseline, Week 6, and Week 12
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Measured using the InBody S10 bioelectrical impedance analyzer.
Phase angle is expressed in degrees (°), and skeletal muscle mass is expressed in kilograms (kg).
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Baseline, Week 6, and Week 12
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- N202404024
Información sobre medicamentos y dispositivos, documentos del estudio
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