Using Combine Walking and Elastic Band to Decrease Fatigue

Cancer Related Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05696275
• Other study ID #: N202208012
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: Taipei Medical University
• Contact: Tsai-Wei Huang, PhD
• Phone: +886-2-27361661
• Email: tsaiwei[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. age 20 years old;

2. diagnosis of cancer;

3. can continuous wearing bracelet for 14 days or more

Exclusion Criteria:

1. Unclear and unable to answer the questionnaire;

2. Not able to walk;

3. platelet <50,000/mm3;

4. ANC 500/cumm

Related Conditions & MeSH terms

• Cancer Related Fatigue
• Fatigue

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cancer fatigue--BFI	severity of fatigue level; measurement tool: Brief Fatigue Index	Change from Baseline post exercise 5 min
Primary	cancer fatigue--BFI	severity of fatigue level; measurement tool: Brief Fatigue Index	Change from Baseline at 1 month.
Secondary	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	Steps count	more steps means good for ability	Change from Baseline post exercise 5 min
Secondary	Steps count	more steps means good for ability	Change from Baseline at 1 month.
Secondary	walking distance	Longer distances mean better movement	Change from Baseline post exercise 5 min
Secondary	walking distance	Longer distances mean better movement	Change from Baseline at 1 month.
Secondary	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
Secondary	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.
Secondary	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.