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 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
150
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Hsiu Ting Tsai, PhD
- Numéro de téléphone: 6330 886227361661
- E-mail: hsiuting@tmu.edu.tw
Sauvegarde des contacts de l'étude
- Nom: Hsin-Hui Huang, Master's degree
- Numéro de téléphone: 6330 886227361661
- E-mail: d432113014@tmu.edu.tw
Lieux d'étude
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Taipei, Taïwan
- Recrutement
- Taipei Medical University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: 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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Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline in Cancer-Related Fatigue (CRF)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 mars 2025
Achèvement primaire (Estimé)
31 juillet 2027
Achèvement de l'étude (Estimé)
31 juillet 2027
Dates d'inscription aux études
Première soumission
26 août 2026
Première soumission répondant aux critères de contrôle qualité
4 septembre 2026
Première publication (Réel)
8 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 septembre 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- N202404024
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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