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NCT Number: 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.

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Key information

Conditions

Lung Cancer (Diagnosis) Disease Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, Taiwan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-Intensity Endurance Continuous Exercise

Behavioral

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.

Low-Intensity Endurance Interval Exercise

Behavioral

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.

Primary outcomes

  1. Change from baseline in Cancer-Related Fatigue (CRF)

    Time frame: Baseline, Week 6, and Week 12

    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.

  2. Change from baseline in mitochondrial oxidative phosphorylation complex enzyme concentrations

    Time frame: Baseline, Week 6, and Week 12

    Concentrations of mitochondrial complex enzymes (Complex I-V) determined via ELISA at an absorbance wavelength of 600 nm. Expressed in ng/mL

  3. Change from baseline in Quality of Life (QoL)

    Time frame: Baseline, Week 6, and Week 12

    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

  4. Change from baseline in phase angle and skeletal muscle mass

    Time frame: Baseline, Week 6, and Week 12

    Measured using the InBody S10 bioelectrical impedance analyzer. Phase angle is expressed in degrees (°), and skeletal muscle mass is expressed in kilograms (kg).

Study contacts

Contact information is provided by the study sponsor or research team.

Hsin-Hui Huang, Master's degree

CONTACT

[email protected]

886227361661 ext. 6330

Hsiu Ting Tsai, PhD

CONTACT

[email protected]

886227361661 ext. 6330

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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