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

Colorectal Cancer Clinical Trial

Official title:

National Taiwan University Hospital Hsin-Chu Branch.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05224518
• Other study ID #: 110-146-E
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: Zih-Yun Deng, BSN
• Phone: 0917741835
• Email: debby820130[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

A. Inclusion criteria

1. Above the age of 20, with colorectal cancer pathological stage in situ, I, II, and III.

2. Coherent, with no mental abnormalities.

3. Able to read Mandarin or communicate in Mandarin and Taiwanese to complete the questionnaire.

4. Provided informed consent.

5. No physical disabilities.

B. Exclusion criteria

1. Acute inflammation of the limbs and joints.

2. Previous abdominal surgery within 3 months.

3. Symptomatic cardiovascular events.

4. Long-term anti-depressant drug use.

5. Unilateral restrictions of the upper or lower limbs.

6. History of medium- or high-intensity exercise for more than half a year.

7. Having colostoma or ileostoma.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Fatigue
• Quality of Life

Intervention

Behavioral:
• elastic band training
elastic band training include stretching exercises

Locations

Country	Name	City	State
Taiwan	NTU Hsin-Chu Hospital	Hsinchu

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch	National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View 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 Internationa — View 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. — View 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, Se — View 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. — View 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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Exercise Counseling and Programming Preferences	Exercise preferences were assessed by questions related to exercise counseling and exercise programming.	baseline
Secondary	Exercise Counseling and Programming Preferences	Exercise preferences were assessed by questions related to exercise counseling and exercise programming.	3rd month after recruited
Secondary	Exercise Counseling and Programming Preferences	Exercise preferences were assessed by questions related to exercise counseling and exercise programming.	6rd month after recruited
Secondary	Exercise Counseling and Programming Preferences	Exercise preferences were assessed by questions related to exercise counseling and exercise programming.	12rd month after recruited
Secondary	Exercise Counseling and Programming Preferences	Exercise preferences were assessed by questions related to exercise counseling and exercise programming.	24rd month after recruited

External Links

•   National cancer institute.