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Using Combine Walking and Elastic Band to Decrease Fatigue

Primary Purpose

Cancer Related Fatigue

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Related Fatigue

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    exercise

    usual care

    Arm Description

    combine walking and elastic band exercise

    as usual care

    Outcomes

    Primary Outcome Measures

    cancer fatigue--BFI
    severity of fatigue level; measurement tool: Brief Fatigue Index
    cancer fatigue--BFI
    severity of fatigue level; measurement tool: Brief Fatigue Index

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    Steps count
    more steps means good for ability
    Steps count
    more steps means good for ability
    walking distance
    Longer distances mean better movement
    walking distance
    Longer distances mean better movement
    strength ability
    Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength
    strength ability
    Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength
    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.

    Full Information

    First Posted
    November 16, 2022
    Last Updated
    January 13, 2023
    Sponsor
    Taipei Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05696275
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 16, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Taipei Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer Related Fatigue

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    exercise
    Arm Type
    Experimental
    Arm Description
    combine walking and elastic band exercise
    Arm Title
    usual care
    Arm Type
    No Intervention
    Arm Description
    as usual care
    Intervention Type
    Behavioral
    Intervention Name(s)
    exercise
    Intervention Description
    20-30 minutes of walking and elastic band exercise per day
    Primary Outcome Measure Information:
    Title
    cancer fatigue--BFI
    Description
    severity of fatigue level; measurement tool: Brief Fatigue Index
    Time Frame
    Change from Baseline post exercise 5 min
    Title
    cancer fatigue--BFI
    Description
    severity of fatigue level; measurement tool: Brief Fatigue Index
    Time Frame
    Change from Baseline at 1 month.
    Secondary Outcome Measure Information:
    Title
    Physical Activity assessment--IPAQ
    Description
    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.
    Time Frame
    Change from Baseline post exercise 5 min
    Title
    Physical Activity assessment--IPAQ
    Description
    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.
    Time Frame
    Change from Baseline at 1 month.
    Title
    Chinese version of the Edmonton Symptom Assessment System,C-ESAS
    Description
    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.
    Time Frame
    Change from Baseline post exercise 5 min
    Title
    Chinese version of the Edmonton Symptom Assessment System,C-ESAS
    Description
    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.
    Time Frame
    Change from Baseline at 1 month.
    Title
    Sleep quality--PSQI
    Description
    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.
    Time Frame
    Change from Baseline post exercise 5 min
    Title
    Sleep quality--PSQI
    Description
    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.
    Time Frame
    Change from Baseline at 1 month.
    Title
    Steps count
    Description
    more steps means good for ability
    Time Frame
    Change from Baseline post exercise 5 min
    Title
    Steps count
    Description
    more steps means good for ability
    Time Frame
    Change from Baseline at 1 month.
    Title
    walking distance
    Description
    Longer distances mean better movement
    Time Frame
    Change from Baseline post exercise 5 min
    Title
    walking distance
    Description
    Longer distances mean better movement
    Time Frame
    Change from Baseline at 1 month.
    Title
    strength ability
    Description
    Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength
    Time Frame
    Change from Baseline post exercise 5 min
    Title
    strength ability
    Description
    Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength
    Time Frame
    Change from Baseline at 1 month.
    Title
    Smart bracelet_Heart rate variability (HRV)
    Description
    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.
    Time Frame
    Continue wear bracelet five days to record HRV data.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tsai-Wei Huang, PhD
    Phone
    +886-2-27361661
    Ext
    6350
    Email
    tsaiwei@tmu.edu.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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