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

September 4, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After enrollment, subjects will be randomly assigned to three groups:

  1. Control Group: No exercise intervention will be implemented. Subjects will maintain their usual lifestyle and daily activities.
  2. 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.
  3. 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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who are diagnosed with lung cancer by a physician ;
  2. Patients aged 20-70 years;
  3. Patients who are determined by a physician, after assessment of their physical condition, to be suitable for exercise;
  4. Patients who have graduated from elementary school or above.

Exclusion Criteria:

  1. Patients who are unable to communicate in Mandarin, Taiwanese, or Hakka;
  2. Patients who are determined by a physician to be physically unsuitable for performing any exercise.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
No exercise intervention will be implemented, and participants will carry out their daily activities according to their previous lifestyle habits.
Experimental: Continuous Training Group
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
Behavioral: Low-Intensity Endurance Continuous Exercise
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.
Experimental: Intermittent Training Group
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.
Behavioral: Low-Intensity Endurance Interval Exercise
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 6, and Week 12
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
Baseline, Week 6, and Week 12
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
Baseline, Week 6, and Week 12
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).
Baseline, Week 6, and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

August 26, 2026

First Submitted That Met QC Criteria

September 4, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202404024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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