Lung Cancer (Diagnosis)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
A study testing Low-Intensity Continuous Endurance Exercise Training and Low-Intensity Interval Endurance Exercise Training in people with Lung Cancer (Diagnosis), run by Taipei Medical University at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis)
- What is being tested?
- Low-Intensity Continuous Endurance Exercise Training and Low-Intensity Interval Endurance Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2026to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with lung cancer by a physician.
- Aged 20 years or older.
- Education level of elementary school graduation or above.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University
Taipei, 110
Wen-Chi Liu, MSc, 02-227372181 ext. 1300, 116085@tmuh.org.tw
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Lung Cancer (Diagnosis)
- Being tested
- Low-Intensity Continuous Endurance Exercise Training, Low-Intensity Interval Endurance Exercise Training
- Keywords
- Low-Intensity Endurance Exercise, Cancer-Related Fatigue (CRF)
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Continuous Endurance Exercise TrainingBehavioural
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 TrainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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. |
| continuous exercise group | Experimental | 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. Receives: Behavioral: Low-Intensity Continuous Endurance Exercise Training |
| low-intensity exercise group | Experimental | 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. Receives: Behavioral: Low-Intensity Interval Endurance Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Cancer-Related Fatigue (CRF)
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.
Measured: Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from baseline in leukocyte mitochondrial DNA copy number and mitochondrial function
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.
Measured: Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from Baseline in Cellular Bioelectrical Impedance Phase Angle and Skeletal Muscle Mass
Measured by the InBody S10 multi-frequency bioelectrical impedance analyzer. Higher phase angle values indicate better cellular integrity and cell function.
Measured: Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from Baseline in Quality of Life (QoL)
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.
Measured: Baseline, Week 6, Week 12, and monthly up to 15 months.
Secondary outcomes (3)
Change from Baseline in Sleep Quality
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.
Measured: Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from Baseline in Perceived Stress
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.
Measured: Baseline, Week 6, Week 12, and monthly up to 15 months.
Predictors of Exercise Adherence (Personality Traits)
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.
Measured: Baseline, Week 6, Week 12, and monthly up to 15 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a two-phase project. Phase 1 applies a cross-sectional observational design to explore the correlations among mitochondrial functions, bioelectrical impedance phase angle, personality traits, and cancer-related fatigue in 450 lung cancer patients. Phase 2 is a randomized controlled trial (RCT) involving 3 parallel arms: (1) a control group, (2) a low-intensity endurance continuous exercise training group, and (3) a low-intensity endurance interval exercise training group, to evaluate the effects of a 12-week exercise intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795580
- Sponsor's protocol ID
- N20261110
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07795580
- Acronym / sponsor ID
- N20261110
- Conditions
- Lung Cancer (Diagnosis)
- Keywords
- Low-Intensity Endurance Exercise, Cancer-Related Fatigue (CRF)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a two-phase project. Phase 1 applies a cross-sectional observational design to explore the correlations among mitochondrial functions, bioelectrical impedance phase angle, personality traits, and cancer-related fatigue in 450 lung cancer patients. Phase 2 is a randomized controlled trial (RCT) involving 3 parallel arms: (1) a control group, (2) a low-intensity endurance continuous exercise training group, and (3) a low-intensity endurance interval exercise training group, to evaluate the effects of a 12-week exercise intervention.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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. |
| continuous exercise group | Experimental | Behavioral: Low-Intensity Continuous Endurance Exercise TrainingParticipants 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. |
| low-intensity exercise group | Experimental | Behavioral: Low-Intensity Interval Endurance Exercise TrainingParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals diagnosed with lung cancer by a physician.
- Aged 20 years or older.
- Education level of elementary school graduation or above.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Intensity Continuous Endurance Exercise TrainingParticipants 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). | Behavioural | continuous exercise group |
| Low-Intensity Interval Endurance Exercise TrainingParticipants 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). | Behavioural | low-intensity exercise group |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Change from Baseline in Sleep Quality
Time frame: Baseline, Week 6, Week 12, and monthly up to 15 months.
Change from Baseline in Perceived Stress
Time frame: Baseline, Week 6, Week 12, and monthly up to 15 months.
Predictors of Exercise Adherence (Personality Traits)
Time frame: Baseline, Week 6, Week 12, and monthly up to 15 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Continuous Endurance Exercise Training and Low-Intensity Interval Endurance Exercise Training in people with Lung Cancer (Diagnosis), run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiu Ting Tsai, PhD (886227361661 ext. 6330, hsiuting@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Cancer-Related Fatigue (CRF) (time frame: Baseline, Week 6, Week 12, and monthly up to 15 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.