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Completed

NCT Number: NCT05696275

Using Combine Walking and Elastic Band to Decrease Fatigue

This study is expected to propose an industry-university cooperation research case for the next two years. When cancer patients use ePRO to record subjective fatigue, and smart watches with 4G communication record objective fatigue, they will be given according to the patient's current degree of mild, moderate and severe fatigue. Suffer from 'exercise or activity' advice and lead the implementation of appropriate exercise advice. This study is expected to design aerobic + anaerobic exercise suitable for mild or moderate patients, and use the sensor of the smart watch to monitor the effect of exercise and fatigue. To sum up, the first-year plan is expected to use the established ePRO electronic records, combined with the LINE communication system, to integrate into a "cancer-related fatigue electronic registration and care system"; the second-year plan will integrate objective fatigue classifiers, Establish the exercise care option in the fatigue care system, and use the smart watch to establish a technology record function of the exercise process to help track the fatigue level of cancer patients.

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Key information

Conditions

Cancer Related Fatigue

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wan Fang Hospital

Taipei, Taiwan, 110

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 20 years old;
  • diagnosis of cancer;
  • can continuous wearing bracelet for 14 days or more

Exclusion criteria

  • Unclear and unable to answer the questionnaire；
  • Not able to walk；
  • platelet <50,000/mm3；
  • ANC 500/cumm

Treatment and study plan

Exercise

Behavioral

20-30 minutes of walking and elastic band exercise per day

Primary outcomes

  1. cancer fatigue--BFI

    Time frame: Change from Baseline post exercise 5 min

    severity of fatigue level; measurement tool: Brief Fatigue Index

  2. cancer fatigue--BFI

    Time frame: Change from Baseline at 1 month.

    severity of fatigue level; measurement tool: Brief Fatigue Index

Secondary outcomes

  1. Physical Activity assessment--IPAQ

    Time frame: Change from Baseline post exercise 5 min

    International Physical Activity Questionnaire (IPAQ), the questionnaire consists of seven questions regarding types of physical activity that constitute elements of everyday life. The questions refer to physical activity in the last seven days and concern the time spent sitting and walking as well as the time devoted to vigorous and moderate physical activity. Activities done for at least 10 min at a time are taken into account. This instrument is used to assess physical activity levels-according to the IPAQ scoring protocol, three levels are distinguished, i.e., low, moderate and high.

  2. Physical Activity assessment--IPAQ

    Time frame: Change from Baseline at 1 month.

    International Physical Activity Questionnaire (IPAQ), the questionnaire consists of seven questions regarding types of physical activity that constitute elements of everyday life. The questions refer to physical activity in the last seven days and concern the time spent sitting and walking as well as the time devoted to vigorous and moderate physical activity. Activities done for at least 10 min at a time are taken into account. This instrument is used to assess physical activity levels-according to the IPAQ scoring protocol, three levels are distinguished, i.e., low, moderate and high.

  3. Chinese version of the Edmonton Symptom Assessment System，C-ESAS

    Time frame: Change from Baseline post exercise 5 min

    The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom.

  4. Chinese version of the Edmonton Symptom Assessment System，C-ESAS

    Time frame: Change from Baseline at 1 month.

    The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom.

  5. Sleep quality--PSQI

    Time frame: Change from Baseline post exercise 5 min

    Pittsburgh Sleep Quality Index (PSQI) scores, is used to assess the quality of sleep of patients - with scores ranging from 0 to 21 - with lower scores indicating better sleep quality.

  6. Sleep quality--PSQI

    Time frame: Change from Baseline at 1 month.

    Pittsburgh Sleep Quality Index (PSQI) scores, is used to assess the quality of sleep of patients - with scores ranging from 0 to 21 - with lower scores indicating better sleep quality.

  7. Steps count

    Time frame: Change from Baseline post exercise 5 min

    more steps means good for ability

  8. Steps count

    Time frame: Change from Baseline at 1 month.

    more steps means good for ability

  9. walking distance

    Time frame: Change from Baseline post exercise 5 min

    Longer distances mean better movement

  10. walking distance

    Time frame: Change from Baseline at 1 month.

    Longer distances mean better movement

  11. strength ability

    Time frame: Change from Baseline post exercise 5 min

    Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength

  12. strength ability

    Time frame: Change from Baseline at 1 month.

    Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength

  13. Smart bracelet_Heart rate variability (HRV)

    Time frame: Continue wear bracelet five days to record HRV data.

    HRV is the physiological phenomenon of the variation in the time interval between consecutive heartbeats in milliseconds. A normal, healthy heart does not tick evenly like a metronome, but instead, when looking at the milliseconds between heartbeats, there is constant variation.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

Exercise-aided Caring System With Dual-mode Assessment Method Using ePRO and Wearables for Cancer-related Fatigue

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2023
Registry last updated
Apr 14, 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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