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
4 de setembro de 2026 atualizado por: Taipei Medical University
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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
150
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Hsiu Ting Tsai, PhD
- Número de telefone: 6330 886227361661
- E-mail: hsiuting@tmu.edu.tw
Estude backup de contato
- Nome: Hsin-Hui Huang, Master's degree
- Número de telefone: 6330 886227361661
- E-mail: d432113014@tmu.edu.tw
Locais de estudo
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Taipei, Taiwan
- Recrutamento
- Taipei Medical University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline in Cancer-Related Fatigue (CRF)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
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Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
10 de março de 2025
Conclusão Primária (Estimado)
31 de julho de 2027
Conclusão do estudo (Estimado)
31 de julho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
26 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de setembro de 2026
Primeira postagem (Real)
8 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de setembro de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- N202404024
Informações sobre medicamentos e dispositivos, documentos de estudo
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