Exercise Intervention to Improve Quality of Life in Patients With Colorectal Cancer

Study Overview
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Brief Summary
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The purpose of this study was to explore the 12-week effectiveness of home exercise intervention for colorectal cancer patients in improving fatigue, sleep, muscle endurance, and quality of life. A. Explore the effect of 12-week home exercise intervention in improving the fatigue of colorectal cancer patients. B. Explore the effect of 12-week home exercise intervention in improving the sleep quality of patients with colorectal cancer. C. Explore the effect of 12-week home exercise intervention in improving the muscle endurance of patients with colorectal cancer. D. Explore the effect of 12-week home exercise intervention in improving the quality of life of colorectal cancer patients.

Detailed Description
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The study was conducted at the colon and rectal outpatient departments. A randomized controlled trial design was adopted. The participants were divided into an interventional group and a conventional therapy control group based on block randomization in a 1:1 ratio. Data were collected when patients returned to the clinic.

Official Title
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National Taiwan University Hospital Hsin-Chu Branch.

Conditions
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Colorectal Cancer, Fatigue, Quality of Life

Intervention / Treatment
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* Behavioral: elastic band training


Participation Criteria
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Eligibility Criteria
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A. Inclusion criteria Above the age of 20, with colorectal cancer pathological stage in situ, I, II, and III. Coherent, with no mental abnormalities. Able to read Mandarin or communicate in Mandarin and Taiwanese to complete the questionnaire. Provided informed consent. No physical disabilities. B. Exclusion criteria Acute inflammation of the limbs and joints. Previous abdominal surgery within 3 months. Symptomatic cardiovascular events. Long-term anti-depressant drug use. Unilateral restrictions of the upper or lower limbs. History of medium- or high-intensity exercise for more than half a year. Having colostoma or ileostoma.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: home-based elastic band training group<br>The interventional group received 12 weeks of home-based elastic band training, three days a week, with progressive, medium-intensity exercise. | Behavioral: elastic band training<br>* elastic band training include stretching exercises<br>* Other names: stretching exercises;|
| Active Comparator: stretching exercises group<br>The control group received home stretching exercises three days a week for 12 weeks. | Behavioral: elastic band training<br>* elastic band training include stretching exercises<br>* Other names: stretching exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of cancer patients(EORTC QLQ-C30) | This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each). | baseline | 
| Quality of life of cancer patients(EORTC QLQ-C30) | This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each). | 1rd month after recruited | 
| Quality of life of cancer patients(EORTC QLQ-C30) | This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each). | 2rd month after recruited | 
| Quality of life of cancer patients(EORTC QLQ-C30) | This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each). | 3rd month after recruited | 
| Quality of life of cancer patients(EORTC QLQ-C30) | This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each). | 6rd month after recruited | 
| Quality of life of cancer patients(EORTC QLQ-C30) | This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each). | 12rd month after recruited | 
| Quality of life of cancer patients(EORTC QLQ-C30) | This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each). | 24rd month after recruited | 
| Quality of life of cancer patients(EORTC QLQ-CR29) | The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom. | baseline | 
| Quality of life of cancer patients(EORTC QLQ-CR29) | The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom. | 1rd month after recruited | 
| Quality of life of cancer patients(EORTC QLQ-CR29) | The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom. | 2rd month after recruited | 
| Quality of life of cancer patients(EORTC QLQ-CR29) | The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom. | 3rd month after recruited | 
| Quality of life of cancer patients(EORTC QLQ-CR29) | The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom. | 6rd month after recruited | 
| Quality of life of cancer patients(EORTC QLQ-CR29) | The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom. | 12rd month after recruited | 
| Quality of life of cancer patients(EORTC QLQ-CR29) | The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom. | 24rd month after recruited | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Fatigue Inventory-Taiwanese (BFI-T) | The Taiwanese Behavior Inventory (BFI-T) has nine questions. The content is divided into two parts: the first part uses three questions to describe the current, average, and most serious degree of fatigue that the patient has experienced, and the second part uses six questions to describe the intensity of the disturbance to life, general activities, emotions, walking ability, and normal work. An 11-Point Likert scale from 0-10 is used to measure fatigue. Briefly, 0 means no feature; 10 means the most serious feature; 1-4 points to distinguish; 5-6 points mean moderate intensity; and 7-9 means severe intensity. In measuring interference with life: 0 means no interference; 10 means complete interference; 1-4 points mean life interference intensity is mild; 5-6 points mean life interference intensity is moderate; and 7-9 points mean life interference intensity is severe. | baseline | 
| Brief Fatigue Inventory-Taiwanese (BFI-T) | The Taiwanese Behavior Inventory (BFI-T) has nine questions. The content is divided into two parts: the first part uses three questions to describe the current, average, and most serious degree of fatigue that the patient has experienced, and the second part uses six questions to describe the intensity of the disturbance to life, general activities, emotions, walking ability, and normal work. An 11-Point Likert scale from 0-10 is used to measure fatigue. Briefly, 0 means no feature; 10 means the most serious feature; 1-4 points to distinguish; 5-6 points mean moderate intensity; and 7-9 means severe intensity. In measuring interference with life: 0 means no interference; 10 means complete interference; 1-4 points mean life interference intensity is mild; 5-6 points mean life interference intensity is moderate; and 7-9 points mean life interference intensity is severe. | 1rd month after recruited | 
| Brief Fatigue Inventory-Taiwanese (BFI-T) | The Taiwanese Behavior Inventory (BFI-T) has nine questions. The content is divided into two parts: the first part uses three questions to describe the current, average, and most serious degree of fatigue that the patient has experienced, and the second part uses six questions to describe the intensity of the disturbance to life, general activities, emotions, walking ability, and normal work. An 11-Point Likert scale from 0-10 is used to measure fatigue. Briefly, 0 means no feature; 10 means the most serious feature; 1-4 points to distinguish; 5-6 points mean moderate intensity; and 7-9 means severe intensity. In measuring interference with life: 0 means no interference; 10 means complete interference; 1-4 points mean life interference intensity is mild; 5-6 points mean life interference intensity is moderate; and 7-9 points mean life interference intensity is severe. | 2rd month after recruited | 
| Brief Fatigue Inventory-Taiwanese (BFI-T) | The Taiwanese Behavior Inventory (BFI-T) has nine questions. The content is divided into two parts: the first part uses three questions to describe the current, average, and most serious degree of fatigue that the patient has experienced, and the second part uses six questions to describe the intensity of the disturbance to life, general activities, emotions, walking ability, and normal work. An 11-Point Likert scale from 0-10 is used to measure fatigue. Briefly, 0 means no feature; 10 means the most serious feature; 1-4 points to distinguish; 5-6 points mean moderate intensity; and 7-9 means severe intensity. In measuring interference with life: 0 means no interference; 10 means complete interference; 1-4 points mean life interference intensity is mild; 5-6 points mean life interference intensity is moderate; and 7-9 points mean life interference intensity is severe. | 3rd month after recruited | 
| Brief Fatigue Inventory-Taiwanese (BFI-T) | The Taiwanese Behavior Inventory (BFI-T) has nine questions. The content is divided into two parts: the first part uses three questions to describe the current, average, and most serious degree of fatigue that the patient has experienced, and the second part uses six questions to describe the intensity of the disturbance to life, general activities, emotions, walking ability, and normal work. An 11-Point Likert scale from 0-10 is used to measure fatigue. Briefly, 0 means no feature; 10 means the most serious feature; 1-4 points to distinguish; 5-6 points mean moderate intensity; and 7-9 means severe intensity. In measuring interference with life: 0 means no interference; 10 means complete interference; 1-4 points mean life interference intensity is mild; 5-6 points mean life interference intensity is moderate; and 7-9 points mean life interference intensity is severe. | 6rd month after recruited | 
| Brief Fatigue Inventory-Taiwanese (BFI-T) | The Taiwanese Behavior Inventory (BFI-T) has nine questions. The content is divided into two parts: the first part uses three questions to describe the current, average, and most serious degree of fatigue that the patient has experienced, and the second part uses six questions to describe the intensity of the disturbance to life, general activities, emotions, walking ability, and normal work. An 11-Point Likert scale from 0-10 is used to measure fatigue. Briefly, 0 means no feature; 10 means the most serious feature; 1-4 points to distinguish; 5-6 points mean moderate intensity; and 7-9 means severe intensity. In measuring interference with life: 0 means no interference; 10 means complete interference; 1-4 points mean life interference intensity is mild; 5-6 points mean life interference intensity is moderate; and 7-9 points mean life interference intensity is severe. | 12rd month after recruited | 
| Brief Fatigue Inventory-Taiwanese (BFI-T) | The Taiwanese Behavior Inventory (BFI-T) has nine questions. The content is divided into two parts: the first part uses three questions to describe the current, average, and most serious degree of fatigue that the patient has experienced, and the second part uses six questions to describe the intensity of the disturbance to life, general activities, emotions, walking ability, and normal work. An 11-Point Likert scale from 0-10 is used to measure fatigue. Briefly, 0 means no feature; 10 means the most serious feature; 1-4 points to distinguish; 5-6 points mean moderate intensity; and 7-9 means severe intensity. In measuring interference with life: 0 means no interference; 10 means complete interference; 1-4 points mean life interference intensity is mild; 5-6 points mean life interference intensity is moderate; and 7-9 points mean life interference intensity is severe. | 24rd month after recruited | 
| Pittsburgh Sleep Quality Index (PSQI) | The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sexual sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor. | baseline | 
| Pittsburgh Sleep Quality Index (PSQI) | The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sexual sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor. | 1rd month after recruited | 
| Pittsburgh Sleep Quality Index (PSQI) | The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sexual sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor. | 2rd month after recruited | 
| Pittsburgh Sleep Quality Index (PSQI) | The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sexual sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor. | 3rd month after recruited | 
| Pittsburgh Sleep Quality Index (PSQI) | The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sexual sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor. | 6rd month after recruited | 
| Pittsburgh Sleep Quality Index (PSQI) | The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sexual sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor. | 12rd month after recruited | 
| Pittsburgh Sleep Quality Index (PSQI) | The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sexual sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor. | 24rd month after recruited | 
| 3-d Physical Activity Record, 3-dPAR | Developed in 1983, this evaluation divides the day from 7 am to midnight into 15 minutes, and divides common activities into the following categories: eating, working, transportation, sleeping, bathing, sports activities, etc., the intensity of which is categorized as very light, light, medium, and strong, and the activity type is coded as level 1-9: corresponding to 1.0-7.8 metabolic equivalent of task (MET) or higher, so as to record three-day physical activity and evaluate the energy consumed and time spent on different activities. | baseline | 
| 3-d Physical Activity Record, 3-dPAR | Developed in 1983, this evaluation divides the day from 7 am to midnight into 15 minutes, and divides common activities into the following categories: eating, working, transportation, sleeping, bathing, sports activities, etc., the intensity of which is categorized as very light, light, medium, and strong, and the activity type is coded as level 1-9: corresponding to 1.0-7.8 metabolic equivalent of task (MET) or higher, so as to record three-day physical activity and evaluate the energy consumed and time spent on different activities. | 3rd month after recruited | 
| 30-second Chair sit-to-stand, 30-s STS | Ability to test mobility and posture transposition. Using a chair without armrests, the number of times the participant could change from a sitting state (leaning back on the chair with both feet on the ground) to fully standing within 30 s was counted. Two tests were performed, with 1 min of rest in between, and the average value was rounded to the nearest value. | baseline | 
| 30-second Chair sit-to-stand, 30-s STS | Ability to test mobility and posture transposition. Using a chair without armrests, the number of times the participant could change from a sitting state (leaning back on the chair with both feet on the ground) to fully standing within 30 s was counted. Two tests were performed, with 1 min of rest in between, and the average value was rounded to the nearest value. | 3rd month after recruited | 
| Six-Minute Walk Test, 6MWT | Functional quantitative indicators for measuring athletic ability and endurance. The participant is asked to walk on a 30-meter flat, straight walkway, marked with red tape every 3 m, and the distance traveled by the individual in six minutes is measured. | baseline | 
| Six-Minute Walk Test, 6MWT | Functional quantitative indicators for measuring athletic ability and endurance. The participant is asked to walk on a 30-meter flat, straight walkway, marked with red tape every 3 m, and the distance traveled by the individual in six minutes is measured. | 3rd month after recruited | 
| Exercise Counseling and Programming Preferences | Exercise preferences were assessed by questions related to exercise counseling and exercise programming. | baseline | 
| Exercise Counseling and Programming Preferences | Exercise preferences were assessed by questions related to exercise counseling and exercise programming. | 3rd month after recruited | 
| Exercise Counseling and Programming Preferences | Exercise preferences were assessed by questions related to exercise counseling and exercise programming. | 6rd month after recruited | 
| Exercise Counseling and Programming Preferences | Exercise preferences were assessed by questions related to exercise counseling and exercise programming. | 12rd month after recruited | 
| Exercise Counseling and Programming Preferences | Exercise preferences were assessed by questions related to exercise counseling and exercise programming. | 24rd month after recruited | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elastic band training, colorectal cancer, exercises