Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07795580

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

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.

Recruiting

Interested in participating?

Request Info

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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, 110, Taiwan

Location status: Recruiting

Location contact

Wen-Chi Liu, MSc

CONTACT

[email protected]

02-227372181 ext. 1300

About this study

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

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Individuals who are unable to communicate in Mandarin Chinese, Taiwanese, or Hakka.
  • Individuals whose physical condition is determined by a physician to be unsuitable for performing any exercise.

Treatment and study plan

Low-Intensity Continuous Endurance Exercise Training

Behavioral

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).

Low-Intensity Interval Endurance Exercise Training

Behavioral

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).

Primary outcomes

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

    Time frame: 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.

  2. Change from baseline in leukocyte mitochondrial DNA copy number and mitochondrial function

    Time frame: 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.

  3. Change from Baseline in Cellular Bioelectrical Impedance Phase Angle and Skeletal Muscle Mass

    Time frame: 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.

  4. Change from Baseline in Quality of Life (QoL)

    Time frame: 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.

Secondary outcomes

  1. Change from Baseline in Sleep Quality

    Time frame: 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.

  2. Change from Baseline in Perceived Stress

    Time frame: 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.

  3. Predictors of Exercise Adherence (Personality Traits)

    Time frame: 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.

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
2026
Primary completion
2028
Study completion
2029
First posted
Aug 31, 2026
Registry last updated
Aug 31, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.