Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT05224518
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2021-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Intervention to Improve Quality of Life in Patients With Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2021-12-12', 'studyFirstSubmitQcDate': '2022-01-25', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life of cancer patients(EORTC QLQ-C30)', 'timeFrame': 'baseline', 'description': '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).'}, {'measure': 'Quality of life of cancer patients(EORTC QLQ-C30)', 'timeFrame': '1rd month after recruited', 'description': '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).'}, {'measure': 'Quality of life of cancer patients(EORTC QLQ-C30)', 'timeFrame': '2rd month after recruited', 'description': '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).'}, {'measure': 'Quality of life of cancer patients(EORTC QLQ-C30)', 'timeFrame': '3rd month after recruited', 'description': '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).'}, {'measure': 'Quality of life of cancer patients(EORTC QLQ-C30)', 'timeFrame': '6rd month after recruited', 'description': '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).'}, {'measure': 'Quality of life of cancer patients(EORTC QLQ-C30)', 'timeFrame': '12rd month after recruited', 'description': '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).'}, {'measure': 'Quality of life of cancer patients(EORTC QLQ-C30)', 'timeFrame': '24rd month after recruited', 'description': '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).'}, {'measure': 'Quality of life of cancer patients(EORTC QLQ-CR29)', 'timeFrame': 'baseline', 'description': '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.'}, {'measure': 'Quality of life of cancer patients(EORTC QLQ-CR29)', 'timeFrame': '1rd month after recruited', 'description': '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.'}, {'measure': 'Quality of life of cancer patients(EORTC QLQ-CR29)', 'timeFrame': '2rd month after recruited', 'description': '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.'}, {'measure': 'Quality of life of cancer patients(EORTC QLQ-CR29)', 'timeFrame': '3rd month after recruited', 'description': '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.'}, {'measure': 'Quality of life of cancer patients(EORTC QLQ-CR29)', 'timeFrame': '6rd month after recruited', 'description': '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.'}, {'measure': 'Quality of life of cancer patients(EORTC QLQ-CR29)', 'timeFrame': '12rd month after recruited', 'description': '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.'}, {'measure': 'Quality of life of cancer patients(EORTC QLQ-CR29)', 'timeFrame': '24rd month after recruited', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Brief Fatigue Inventory-Taiwanese (BFI-T)', 'timeFrame': 'baseline', 'description': '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.\n\nAn 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.'}, {'measure': 'Brief Fatigue Inventory-Taiwanese (BFI-T)', 'timeFrame': '1rd month after recruited', 'description': '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.\n\nAn 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.'}, {'measure': 'Brief Fatigue Inventory-Taiwanese (BFI-T)', 'timeFrame': '2rd month after recruited', 'description': '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.\n\nAn 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.'}, {'measure': 'Brief Fatigue Inventory-Taiwanese (BFI-T)', 'timeFrame': '3rd month after recruited', 'description': '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.\n\nAn 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.'}, {'measure': 'Brief Fatigue Inventory-Taiwanese (BFI-T)', 'timeFrame': '6rd month after recruited', 'description': '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.\n\nAn 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.'}, {'measure': 'Brief Fatigue Inventory-Taiwanese (BFI-T)', 'timeFrame': '12rd month after recruited', 'description': '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.\n\nAn 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.'}, {'measure': 'Brief Fatigue Inventory-Taiwanese (BFI-T)', 'timeFrame': '24rd month after recruited', 'description': '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.\n\nAn 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.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'baseline', 'description': '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.\n\nThe 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.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '1rd month after recruited', 'description': '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.\n\nThe 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.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '2rd month after recruited', 'description': '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.\n\nThe 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.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '3rd month after recruited', 'description': '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.\n\nThe 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.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '6rd month after recruited', 'description': '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.\n\nThe 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.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '12rd month after recruited', 'description': '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.\n\nThe 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.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '24rd month after recruited', 'description': '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.\n\nThe 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.'}, {'measure': '3-d Physical Activity Record, 3-dPAR', 'timeFrame': 'baseline', 'description': '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.'}, {'measure': '3-d Physical Activity Record, 3-dPAR', 'timeFrame': '3rd month after recruited', 'description': '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.'}, {'measure': '30-second Chair sit-to-stand, 30-s STS', 'timeFrame': 'baseline', 'description': '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.'}, {'measure': '30-second Chair sit-to-stand, 30-s STS', 'timeFrame': '3rd month after recruited', 'description': '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.'}, {'measure': 'Six-Minute Walk Test, 6MWT', 'timeFrame': 'baseline', 'description': 'Functional quantitative indicators for measuring athletic ability and endurance.\n\nThe 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.'}, {'measure': 'Six-Minute Walk Test, 6MWT', 'timeFrame': '3rd month after recruited', 'description': 'Functional quantitative indicators for measuring athletic ability and endurance.\n\nThe 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.'}, {'measure': 'Exercise Counseling and Programming Preferences', 'timeFrame': 'baseline', 'description': 'Exercise preferences were assessed by questions related to exercise counseling and exercise programming.'}, {'measure': 'Exercise Counseling and Programming Preferences', 'timeFrame': '3rd month after recruited', 'description': 'Exercise preferences were assessed by questions related to exercise counseling and exercise programming.'}, {'measure': 'Exercise Counseling and Programming Preferences', 'timeFrame': '6rd month after recruited', 'description': 'Exercise preferences were assessed by questions related to exercise counseling and exercise programming.'}, {'measure': 'Exercise Counseling and Programming Preferences', 'timeFrame': '12rd month after recruited', 'description': 'Exercise preferences were assessed by questions related to exercise counseling and exercise programming.'}, {'measure': 'Exercise Counseling and Programming Preferences', 'timeFrame': '24rd month after recruited', 'description': 'Exercise preferences were assessed by questions related to exercise counseling and exercise programming.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['elastic band training', 'colorectal cancer', 'exercises'], 'conditions': ['Colorectal Cancer', 'Fatigue', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '8433390', 'type': 'BACKGROUND', 'citation': 'Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.'}, {'pmid': '29076609', 'type': 'BACKGROUND', 'citation': 'Chen Y, Niu M, Zhang X, Qian H, Xie A, Wang X. Effects of home-based lower limb resistance training on muscle strength and functional status in stable Chronic obstructive pulmonary disease patients. J Clin Nurs. 2018 Mar;27(5-6):e1022-e1037. doi: 10.1111/jocn.14131. Epub 2018 Feb 6.'}, {'pmid': '23851406', 'type': 'BACKGROUND', 'citation': "Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available."}, {'pmid': '31626055', 'type': 'RESULT', 'citation': 'Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.'}, {'pmid': '31626056', 'type': 'RESULT', 'citation': 'Patel AV, Friedenreich CM, Moore SC, Hayes SC, Silver JK, Campbell KL, Winters-Stone K, Gerber LH, George SM, Fulton JE, Denlinger C, Morris GS, Hue T, Schmitz KH, Matthews CE. American College of Sports Medicine Roundtable Report on Physical Activity, Sedentary Behavior, and Cancer Prevention and Control. Med Sci Sports Exerc. 2019 Nov;51(11):2391-2402. doi: 10.1249/MSS.0000000000002117.'}, {'pmid': '28651827', 'type': 'RESULT', 'citation': 'Uster A, Ruehlin M, Mey S, Gisi D, Knols R, Imoberdorf R, Pless M, Ballmer PE. Effects of nutrition and physical exercise intervention in palliative cancer patients: A randomized controlled trial. Clin Nutr. 2018 Aug;37(4):1202-1209. doi: 10.1016/j.clnu.2017.05.027. Epub 2017 Jun 8.'}], 'seeAlsoLinks': [{'url': 'https://www.cancer.gov/about-cancer/treatment/side-effects/fatigue/fatigue-hp-pdq', 'label': 'National cancer institute.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nA. Explore the effect of "12-week home exercise intervention" in improving the fatigue of colorectal cancer patients.\n\nB. Explore the effect of "12-week home exercise intervention" in improving the sleep quality of patients with colorectal cancer.\n\nC. Explore the effect of "12-week home exercise intervention" in improving the muscle endurance of patients with colorectal cancer.\n\nD. Explore the effect of "12-week home exercise intervention" in improving the quality of life of colorectal cancer patients.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'A. Inclusion criteria\n\n1. Above the age of 20, with colorectal cancer pathological stage in situ, I, II, and III.\n2. Coherent, with no mental abnormalities.\n3. Able to read Mandarin or communicate in Mandarin and Taiwanese to complete the questionnaire.\n4. Provided informed consent.\n5. No physical disabilities.\n\nB. Exclusion criteria\n\n1. Acute inflammation of the limbs and joints.\n2. Previous abdominal surgery within 3 months.\n3. Symptomatic cardiovascular events.\n4. Long-term anti-depressant drug use.\n5. Unilateral restrictions of the upper or lower limbs.\n6. History of medium- or high-intensity exercise for more than half a year.\n7. Having colostoma or ileostoma.'}, 'identificationModule': {'nctId': 'NCT05224518', 'briefTitle': 'Exercise Intervention to Improve Quality of Life in Patients With Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital Hsin-Chu Branch'}, 'officialTitle': 'National Taiwan University Hospital Hsin-Chu Branch.', 'orgStudyIdInfo': {'id': '110-146-E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'home-based elastic band training group', 'description': 'The interventional group received 12 weeks of home-based elastic band training, three days a week, with progressive, medium-intensity exercise.', 'interventionNames': ['Behavioral: elastic band training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'stretching exercises group', 'description': 'The control group received home stretching exercises three days a week for 12 weeks.', 'interventionNames': ['Behavioral: elastic band training']}], 'interventions': [{'name': 'elastic band training', 'type': 'BEHAVIORAL', 'otherNames': ['stretching exercises'], 'description': 'elastic band training include stretching exercises', 'armGroupLabels': ['home-based elastic band training group', 'stretching exercises group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300', 'city': 'Hsinchu', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Zih-Yun Deng', 'role': 'CONTACT', 'email': 'debby820130@gmail.com', 'phone': '0917741835'}], 'facility': 'NTU Hsin-Chu Hospital', 'geoPoint': {'lat': 24.80361, 'lon': 120.96861}}], 'centralContacts': [{'name': 'Zih-Yun Deng, BSN', 'role': 'CONTACT', 'email': 'debby820130@gmail.com', 'phone': '0917741835'}, {'name': 'Hui-Mei Chen, PhD', 'role': 'CONTACT', 'email': 'alice@ntunhs.edu.tw', 'phone': '02-28227101', 'phoneExt': '3139'}], 'overallOfficials': [{'name': 'Hui-Mei Chen', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Nursing and Health Sciences, Taipei, Taiwan'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 24 months following article publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after de identification (text, tables, figures, and appendices).', 'accessCriteria': 'Researchers who provide a methodologically sound proposal and receive the authors consent.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital Hsin-Chu Branch', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Taipei University of Nursing and Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}