The Effects of Remote Exercise Program in Patients With Digestive Tract Cancer and Chemotherapy-induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- body weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 and above;
- •Diagnosed by a physician with gastrointestinal cancer and has undergone chemotherapy or is currently undergoing chemotherapy;
- •Diagnosed by a physician with chemotherapy-induced peripheral neuropathy.
排除标准
- •Cognitive impairment or inability to cooperate with verbal instructions;
- •Neurological, muscular, skeletal, or cardiovascular issues preventing participation in exercise training;
- •Age 80 or above;
- •Refusal to engage in exercise intervention or participate in data collection.
研究组 & 干预措施
remote home-based exercise therapy group
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).
干预措施: remote home-based exercise therapy group (Other)
regular care group
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.
干预措施: regular care group (Other)
supervised exercise therapy group
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.
干预措施: supervised exercise therapy group (Other)
结局指标
主要结局
body weight
时间窗: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
body weight in kg
body height
时间窗: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
body height in m
gene
时间窗: baseline
gene
body mass index
时间窗: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
body mass index in kg/m2
Basic information
时间窗: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
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.
blood data
时间窗: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
blood data, including blood cell count, neutrophils, lymphocytes, monocytes, hemoglobin, albumin, magnesium, mean corpuscular volume, etc.
Questionnaire of Chemotherapy-Induced Peripheral Neuropathy
时间窗: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
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.
Questionnaire of Quality of Life
时间窗: baseline, 4-week intervention, 8-week intervention, and 3 month after intervention
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.
次要结局
- Sensation Test(baseline, 4-week intervention, 8-week intervention, and 3 month after intervention)
- Muscle Strength(baseline, 4-week intervention, 8-week intervention, and 3 month after intervention)
- Cardiovascular Endurance(baseline, 4-week intervention, 8-week intervention, and 3 month after intervention)
- Dynamic Balance(baseline, 4-week intervention, 8-week intervention, and 3 month after intervention)