Using Combine Walking and Elastic Band to Decrease Fatigue

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer Related Fatigue
• Intervention / Treatment: Behavioral: exercise

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tsai-Wei Huang, PhD; Phone Number: 6350 +886-2-27361661; Email: tsaiwei@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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.
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.

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 16, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Estimate): January 24, 2023

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: N202208012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No