Clinical trial NCT05696275: Using Combine Walking and Elastic Band to Decrease Fatigue
Official title: Exercise-aided Caring System With Dual-mode Assessment Method Using ePRO and Wearables for Cancer-related Fatigue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Related Fatigue
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: cancer fatigue--BFI
timeFrame: Change from Baseline post exercise 5 min
measure: cancer fatigue--BFI
timeFrame: Change from Baseline at 1 month.
Secondary outcomes:
measure: Physical Activity assessment--IPAQ
timeFrame: Change from Baseline post exercise 5 min
measure: Physical Activity assessment--IPAQ
timeFrame: Change from Baseline at 1 month.
measure: Chinese version of the Edmonton Symptom Assessment System，C-ESAS
timeFrame: Change from Baseline post exercise 5 min
measure: Chinese version of the Edmonton Symptom Assessment System，C-ESAS
timeFrame: Change from Baseline at 1 month.
measure: Sleep quality--PSQI
timeFrame: Change from Baseline post exercise 5 min
measure: Sleep quality--PSQI
timeFrame: Change from Baseline at 1 month.
measure: Steps count
timeFrame: Change from Baseline post exercise 5 min
measure: Steps count
timeFrame: Change from Baseline at 1 month.
measure: walking distance
timeFrame: Change from Baseline post exercise 5 min
measure: walking distance
timeFrame: Change from Baseline at 1 month.
measure: strength ability
timeFrame: Change from Baseline post exercise 5 min
measure: strength ability
timeFrame: Change from Baseline at 1 month.
measure: Smart bracelet_Heart rate variability (HRV)
timeFrame: Continue wear bracelet five days to record HRV data.
Other outcomes:
Locations:
Study officials:
References: