Lung Cancer (Diagnosis)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
A study testing Low-Intensity Endurance Continuous Exercise and Low-Intensity Endurance Interval Exercise 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 to 70 years
- Conditions the study is for
- Lung Cancer (Diagnosis)
- What is being tested?
- Low-Intensity Endurance Continuous Exercise and Low-Intensity Endurance Interval Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Mar 2025to 31 Jul 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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.
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.
Read the detailed description
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.
- Conditions
- Lung Cancer (Diagnosis)
- Being tested
- Low-Intensity Endurance Continuous Exercise, Low-Intensity Endurance Interval Exercise
- Keywords
- Cancer-Related Fatigue, Endurance Exercise, Mitochondrial Function, Bioelectrical Impedance Phase Angle, Quality of Life, Lung Cancer
- 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 Endurance Continuous ExerciseBehavioural
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 ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No exercise intervention will be implemented, and participants will carry out their daily activities according to their previous lifestyle habits. |
| Continuous Training Group | Experimental | 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 Receives: Behavioral: Low-Intensity Endurance Continuous Exercise |
| Intermittent Training Group | Experimental | 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. Receives: Behavioral: Low-Intensity Endurance Interval Exercise |
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). 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.
Measured: Baseline, Week 6, and Week 12
Change from baseline in mitochondrial oxidative phosphorylation complex enzyme concentrations
Concentrations of mitochondrial complex enzymes (Complex I-V) determined via ELISA at an absorbance wavelength of 600 nm. Expressed in ng/mL
Measured: Baseline, Week 6, and Week 12
Change from baseline in Quality of Life (QoL)
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
Measured: Baseline, Week 6, and Week 12
Change from baseline in phase angle and skeletal muscle mass
Measured using the InBody S10 bioelectrical impedance analyzer. Phase angle is expressed in degrees (°), and skeletal muscle mass is expressed in kilograms (kg).
Measured: Baseline, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start10 Mar 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (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
- A randomized controlled trial with 3 parallel groups: (1) Control group: maintaining usual lifestyle; (2) Continuous training group: low-intensity endurance continuous exercise for 30 mins, 5 days/week for 12 weeks; (3) Intermittent training group: low-intensity endurance intermittent exercise (alternating level 2 and level 1 intensity) for 30 mins, 5 days/week for 12 weeks.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 150 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
- NCT07806682
- Sponsor's protocol ID
- N202404024
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 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 Mitochondrial Function, Cell Bioelectrical Impedance Phase Angle, Fatigue and Quality of Life in Lung Cancer Patients With Cancer-related Fatigue
- ClinicalTrials.gov ID
- NCT07806682
- Acronym / sponsor ID
- N202404024
- Conditions
- Lung Cancer (Diagnosis)
- Keywords
- Cancer-Related Fatigue, Endurance Exercise, Mitochondrial Function, Bioelectrical Impedance Phase Angle, Quality of Life, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 Sep 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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- A randomized controlled trial with 3 parallel groups: (1) Control group: maintaining usual lifestyle; (2) Continuous training group: low-intensity endurance continuous exercise for 30 mins, 5 days/week for 12 weeks; (3) Intermittent training group: low-intensity endurance intermittent exercise (alternating level 2 and level 1 intensity) for 30 mins, 5 days/week for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No exercise intervention will be implemented, and participants will carry out their daily activities according to their previous lifestyle habits. |
| Continuous Training Group | Experimental | Behavioral: Low-Intensity Endurance Continuous ExerciseLevel 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 |
| Intermittent Training Group | Experimental | Behavioral: Low-Intensity Endurance Interval ExerciseParticipants 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 Endurance Continuous ExerciseParticipants 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. | Behavioural | Continuous Training Group |
| Low-Intensity Endurance Interval ExerciseParticipants 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. | Behavioural | Intermittent Training Group |
Primary outcome
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.
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
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
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).
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 8 Sep 2026.
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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 Endurance Continuous Exercise and Low-Intensity Endurance Interval Exercise 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 4 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 8 Sep 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, and Week 12). 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 8 Sep 2026.