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| Name | Class |
|---|---|
| National Cheng Kung University | OTHER |
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According to the incidence rate of cancer, the digestive tract cancer accounts for two of the top ten cancers. It also accounts for half of the top ten causes of cancer death. Chemotherapy remains one of the most common forms of cancer treatment, and chemotherapy-induced peripheral neuropathy (CIPN) is one of the common adverse effects of cancer treatment in cancer survivors. To date, there is no exercise guideline established for patients with CIPN; therefore, CIPN remains quite threatening to cancer survivors. Due to limited studies on effects of exercise on improvement of CIPN symptoms in patients with digestive tract cancers, this study aims to investigate the effects of exercise and different intervention delivery modes (remote home exercise and exercise under supervision) at different time points on the CIPN symptoms, body inflammatory index, physical function, and quality of life of gastrointestinal cancer survivors with chemotherapy-induced peripheral neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remote home-based exercise therapy group | Experimental | Location and Frequency: Four times per week at the individual's own home. Exercise Duration: Eight weeks (subject to adjustments based on actual progress), with a total exercise time of 40 minutes each session. Exercise Components: Cardiovascular endurance exercise, resistance training, sensory exercises. Note: The participant will receive a customized exercise plan based on their capabilities, including guidelines and exercise instructions (exercise names, required equipment, movement sequences, repetitions, precautions). |
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| supervised exercise therapy group | Active Comparator | Exercise Location and Frequency: Physiotherapy Center (twice a week) and individual's home (twice a week). Exercise Duration: Eight weeks (subject to adjustments based on actual progress), with a total exercise time of 40 minutes each session. Exercise Components: Cardiovascular endurance exercise, resistance training, sensory training exercises. The home-based exercise training content is partially the same as the remote home-based exercise group. |
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| regular care group | Other | Perform regular care for eight consecutive weeks. After the tracking period ends (8 weeks), provide home-based education on resistance exercises, cardiovascular endurance exercises, and sensory training exercises. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote home-based exercise therapy group | Other | Location and Frequency: Four times per week at the individual's ownhome. Exercise Duration: Eight weeks (subject to adjustments based onactual progress), with a total exercise time of 40 minutes each session. Exercise Components: Cardiovascular endurance exercise, resistancetraining, sensory exercises. Note: The participant will receive a customized exercise plan based ontheir capabilities, including guidelines and exercise instructions (exercisenames, required equipment, movement sequences, repetitions,precautions). |
| Measure | Description | Time Frame |
|---|---|---|
| Basic information | Gender, date of birth, education level, survival days and status, exercise habit, alcohol consume history, smoking history, type of cancer, stage of cancer, start date of chemotherapy, number of chemotherapy sessions prior to intervention, chemotherapy drugs used, study period, and the subjects' medical history. | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention |
| gene | gene | baseline |
| body height | body height in m | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention |
| body weight | body weight in kg | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention |
| body mass index | body mass index in kg/m2 | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention |
| blood data | blood data, including blood cell count, neutrophils, lymphocytes, monocytes, hemoglobin, albumin, magnesium, mean corpuscular volume, etc. | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention |
| Questionnaire of Quality of Life | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) is to assess the quality of life. The transferred score range for this tool is typically from 0 to 100, where 0 indicates very poor quality of life, and 100 indicates very good quality of life. There are five aspects in the QLQ-C30, including physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning. In this scoring system, higher scores generally indicate better quality of life, while lower scores suggest poorer quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Strength | Evaluate muscle strength using grip strength assessment device. Participant grips device withdominant hand using maximum effort. | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention |
| Dynamic Balance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng-Feng Lin, Ph.D | Contact | 886-6-2353535 | 5911 | connie@mail.ncku.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Cheng-Feng Lin, Ph.D | Department of Physical Therapy, National Cheng-Kung University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Therapy, National Cheng-Kung University | Recruiting | Tainan | 701 | Taiwan |
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| supervised exercise therapy group | Other | Exercise Location and Frequency: Physiotherapy Center (twice a week)and individual's home (twice a week). Exercise Duration: Eight weeks (subject to adjustments based on actualprogress), with a total exercise time of 40 minutes each session. Exercise Components: Cardiovascular endurance exercise, resistancetraining, sensory training exercises. The home-based exercise trainingcontent is partially the same as the remote home-based exercise group. |
|
| regular care group | Other | Perform regular care for eight consecutive weeks. After the trackingperiod ends (8 weeks), provide home-based education on resistanceexercises, cardiovascular endurance exercises, and sensory trainingexercises. |
|
| baseline, 4-week intervention, 8-week intervention, and 3 month after intervention |
| Questionnaire of Chemotherapy-Induced Peripheral Neuropathy | The European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy 20-item scale (CIPN-20) assesses sensory abnormalities in patients. Scores range from 0 to 80, with 0 indicating no abnormalities and 80 severe abnormalities. Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The total score is calculated by adding scores from items 1 to 19, ranging from 19 to 76, termed the CIPN20 sum1-19 score. Item 20 evaluates male impotence, relevant only for males. Additionally, items are categorized into sensory (1, 2, 3, 4, 5, 6, 9, 10, and 18), motor (7, 8, 11, 12, 13, 14, 15, and 19), and autonomic (16, 17, and 20) subscales. | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention |
Use Timed Up & Go (TUG) test. Participant stands from chair upon signal, walks 3m at normal pace,returns, and sits. Time recorded
| baseline, 4-week intervention, 8-week intervention, and 3 month after intervention |
| Sensation Test | Assess sensory issues from neuropathy using Romberg test | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention |
| Cardiovascular Endurance | Assess using 2-min step test. Participant steps in place for 2 mins, feet higher thanmidpoint between patella and iliac spine. Tester notes successful steps in 2 mins. | baseline, 4-week intervention, 8-week intervention, and 3 month after intervention |