Using Combine Walking and Elastic Band to Decrease Fatigue

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer Related Fatigue

Intervention / Treatment
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* Behavioral: exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise<br>combine walking and elastic band exercise | Behavioral: exercise<br>* 20-30 minutes of walking and elastic band exercise per day<br>|
| No Intervention: usual care<br>as usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cancer fatigue--BFI | severity of fatigue level; measurement tool: Brief Fatigue Index | Change from Baseline post exercise 5 min | 
| cancer fatigue--BFI | severity of fatigue level; measurement tool: Brief Fatigue Index | Change from Baseline at 1 month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity assessment--IPAQ | 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. | Change from Baseline post exercise 5 min | 
| Physical Activity assessment--IPAQ | 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. | Change from Baseline at 1 month. | 
| Chinese version of the Edmonton Symptom Assessment System，C-ESAS | 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. | Change from Baseline post exercise 5 min | 
| Chinese version of the Edmonton Symptom Assessment System，C-ESAS | 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. | Change from Baseline at 1 month. | 
| Sleep quality--PSQI | 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. | Change from Baseline post exercise 5 min | 
| Sleep quality--PSQI | 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. | Change from Baseline at 1 month. | 
| Steps count | more steps means good for ability | Change from Baseline post exercise 5 min | 
| Steps count | more steps means good for ability | Change from Baseline at 1 month. | 
| walking distance | Longer distances mean better movement | Change from Baseline post exercise 5 min | 
| walking distance | Longer distances mean better movement | Change from Baseline at 1 month. | 
| strength ability | Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength | Change from Baseline post exercise 5 min | 
| strength ability | Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength | Change from Baseline at 1 month. | 
| Smart bracelet_Heart rate variability (HRV) | 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. | Continue wear bracelet five days to record HRV data. |