Using Combine Walking and Elastic Band to Decrease Fatigue

Sponsor
Taipei Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05696275
Collaborator
(none)
120
2
23.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Exercise-aided Caring System With Dual-mode Assessment Method Using ePRO and Wearables for Cancer-related Fatigue
Anticipated Study Start Date :
Jan 16, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. cancer fatigue--BFI [Change from Baseline post exercise 5 min]

    severity of fatigue level; measurement tool: Brief Fatigue Index

  2. cancer fatigue--BFI [Change from Baseline at 1 month.]

    severity of fatigue level; measurement tool: Brief Fatigue Index

Secondary Outcome Measures

  1. Physical Activity assessment--IPAQ [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 [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 [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 [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 [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 [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 [Change from Baseline post exercise 5 min]

    more steps means good for ability

  8. Steps count [Change from Baseline at 1 month.]

    more steps means good for ability

  9. walking distance [Change from Baseline post exercise 5 min]

    Longer distances mean better movement

  10. walking distance [Change from Baseline at 1 month.]

    Longer distances mean better movement

  11. strength ability [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 [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Taipei Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tsai-Wei Huang, Professor, Taipei Medical University
ClinicalTrials.gov Identifier:
NCT05696275
Other Study ID Numbers:
  • N202208012
First Posted:
Jan 25, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2023