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The Effects of Low-Intensity Endurance Exercise on Improving Fatigue, Sleep, Quality of Life, Mitochondrial Function, Cellular Bioelectrical Impedance Phase Angle, and Predictors of Exercise Adherence in Patients With Lung Cancer

26 août 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.

Objective 3: To investigate the correlation between personality traits and adherence to low-intensity endurance exercise in lung cancer patients.

Objective 4: To investigate whether a low-intensity endurance exercise intervention can effectively improve sleep quality in lung cancer patients with cancer-related fatigue.

Objective 5: To investigate whether a low-intensity endurance exercise intervention can effectively reduce stress in lung cancer patients with cancer-related fatigue.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

After enrollment, participants will be randomly assigned to one of the following three groups:

  1. Control Group Participants assigned to the control group will not receive any exercise intervention and will be instructed to maintain their usual daily lifestyle and physical activity throughout the study period.

  2. Low-Intensity Continuous Endurance Exercise Training Group (Level 2) Participants will perform Level 2 low-intensity continuous endurance exercise for at least 30 consecutive minutes per day, 5 days per week. Exercise intensity will be maintained at 75-80% of peak heart rate (HRpeak), corresponding to a Rating of Perceived Exertion (RPE) of 11-12 (light). At this intensity, participants should perceive the exercise as relatively easy, with an increased breathing rate but still be able to carry on a conversation comfortably, although occasional pauses for breathing may be required.

    Each exercise session will consist of:

    • a 5-minute warm-up,
    • 30 minutes of continuous low-intensity endurance exercise, and
    • a 10-minute cool-down, during which exercise intensity will be gradually reduced until cessation.
  3. Low-Intensity Interval Endurance Exercise Training Group

Participants will perform 30 minutes of interval endurance exercise per day, 5 days per week. Each session will consist of five alternating cycles, with each cycle including:

  • 3 minutes of Level 2 low-intensity endurance exercise at 75-80% HRpeak (RPE 11-12), followed by
  • 3 minutes of Level 1 very low-intensity endurance exercise at 65-75% HRpeak, corresponding to an RPE <11 (very light), during which participants should perceive the exercise as very easy.

Each exercise session will begin with a 5-minute warm-up and conclude with a 10-minute cool-down, during which exercise intensity will be gradually reduced until exercise cessation.

Type d'étude

Interventionnel

Inscription (Estimé)

450

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

  • Taïwan
      • Taipei, Taïwan, 110
        • Recrutement
        • Taipei Medical University
        • Contact:

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:

  1. Individuals diagnosed with lung cancer by a physician.
  2. Aged 20 years or older.
  3. Education level of elementary school graduation or above.

Exclusion Criteria:

  1. Individuals who are unable to communicate in Mandarin Chinese, Taiwanese, or Hakka.
  2. Individuals whose physical condition is determined by a physician to be 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
Aucune intervention: Control Group
Participants assigned to the control group will not receive any exercise intervention and will be instructed to maintain their usual daily lifestyle and physical activity throughout the study period.
Expérimental: continuous exercise group
Participants will perform Level 2 low-intensity continuous endurance exercise for at least 30 consecutive minutes per day, 5 days per week. Exercise intensity will be maintained at 75-80% of peak heart rate (HRpeak), corresponding to a Rating of Perceived Exertion (RPE) of 11-12 (light). Each exercise session will consist of a 5-minute warm-up, 30 minutes of continuous low-intensity endurance exercise, and a 10-minute cool-down.
Comportemental: Low-Intensity Continuous Endurance Exercise Training
Participants will perform Level 2 low-intensity continuous endurance exercise for at least 30 consecutive minutes per day, 5 days per week. Intensity at 75-80% HRpeak (RPE 11-12).
Expérimental: low-intensity exercise group
Participants will perform 30 minutes of interval endurance exercise per day, 5 days per week. Each session will consist of five alternating cycles, with each cycle including 3 minutes of Level 2 low-intensity endurance exercise at 75-80% HRpeak (RPE 11-12), followed by 3 minutes of Level 1 very low-intensity endurance exercise at 65-75% HRpeak (RPE <11). Each exercise session will begin with a 5-minute warm-up and conclude with a 10-minute cool-down.
Comportemental: Low-Intensity Interval Endurance Exercise Training
Participants will perform 30 minutes of interval endurance exercise per day, 5 days per week. Five alternating cycles (3 mins Level 2 at 75-80% HRpeak + 3 mins Level 1 at 65-75% HRpeak).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline in Cancer-Related Fatigue (CRF)
Délai: Baseline, Week 6, Week 12, and monthly up to 15 months.
Evaluated by the Brief Fatigue Inventory-Taiwan (BFI-T) and the ICD-10 diagnostic criteria for cancer-related fatigue. The BFI-T total score ranges from 0 to 90, with higher scores indicating greater fatigue severity and interference with daily life.
Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from baseline in leukocyte mitochondrial DNA copy number and mitochondrial function
Délai: Baseline, Week 6, Week 12, and monthly up to 15 months.
Leukocyte mitochondrial DNA (mtDNA) copy number will be quantified using real-time quantitative PCR (qPCR) by calculating the relative mtDNA-to-nuclear DNA ratio. Mitochondrial function will be evaluated by measuring the oxygen consumption rate (OCR) and ATP coupling efficiency using the Seahorse XFp extracellular flux analyzer.
Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from Baseline in Cellular Bioelectrical Impedance Phase Angle and Skeletal Muscle Mass
Délai: Baseline, Week 6, Week 12, and monthly up to 15 months.
Measured by the InBody S10 multi-frequency bioelectrical impedance analyzer. Higher phase angle values indicate better cellular integrity and cell function.
Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from Baseline in Quality of Life (QoL)
Délai: Baseline, Week 6, Week 12, and monthly up to 15 months.
Evaluated using the Functional Assessment of Cancer Therapy-General (FACT-G) Taiwan version. The total score ranges from 0 to 108, with higher scores representing better health-related quality of life.
Baseline, Week 6, Week 12, and monthly up to 15 months.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from Baseline in Sleep Quality
Délai: Baseline, Week 6, Week 12, and monthly up to 15 months.
Assessed by the Pittsburgh Sleep Quality Index (PSQI) Taiwan form. Total scores range from 0 to 21, where a score > 5 indicates poor sleep quality.
Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from Baseline in Perceived Stress
Délai: Baseline, Week 6, Week 12, and monthly up to 15 months.
Measured by the 10-item Perceived Stress Scale (PSS-10). Total scores range from 0 to 40, with higher scores indicating higher levels of perceived stress.
Baseline, Week 6, Week 12, and monthly up to 15 months.
Predictors of Exercise Adherence (Personality Traits)
Délai: Baseline, Week 6, Week 12, and monthly up to 15 months.
Evaluated using the International English Big-Five Mini-Markers (Chinese version) at baseline to explore its correlation with the 12-week low-intensity endurance exercise adherence rate.
Baseline, Week 6, Week 12, and monthly up to 15 months.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Taipei Medical University

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)

1 juillet 2026

Achèvement primaire (Estimé)

1 juillet 2028

Achèvement de l'étude (Estimé)

1 juillet 2029

Dates d'inscription aux études

Première soumission

26 août 2026

Première soumission répondant aux critères de contrôle qualité

26 août 2026

Première publication (Réel)

31 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

31 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 août 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

  • N20261110

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

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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