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NCT Number: NCT05224518

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NTU Hsin-Chu Hospital

Hsinchu, 300, Taiwan

Location status: Recruiting

Location contact

Zih-Yun Deng

CONTACT

[email protected]

0917741835

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elastic Band Training

Behavioral

elastic band training include stretching exercises

Other names: stretching exercises

Primary outcomes

  1. Quality of life of cancer patients(EORTC QLQ-C30)

    Time frame: baseline

    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).

  2. Quality of life of cancer patients(EORTC QLQ-C30)

    Time frame: 1rd month after recruited

    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).

  3. Quality of life of cancer patients(EORTC QLQ-C30)

    Time frame: 2rd month after recruited

    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).

  4. Quality of life of cancer patients(EORTC QLQ-C30)

    Time frame: 3rd month after recruited

    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).

  5. Quality of life of cancer patients(EORTC QLQ-C30)

    Time frame: 6rd month after recruited

    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).

  6. Quality of life of cancer patients(EORTC QLQ-C30)

    Time frame: 12rd month after recruited

    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).

  7. Quality of life of cancer patients(EORTC QLQ-C30)

    Time frame: 24rd month after recruited

    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).

  8. Quality of life of cancer patients(EORTC QLQ-CR29)

    Time frame: baseline

    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.

  9. Quality of life of cancer patients(EORTC QLQ-CR29)

    Time frame: 1rd month after recruited

    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.

  10. Quality of life of cancer patients(EORTC QLQ-CR29)

    Time frame: 2rd month after recruited

    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.

  11. Quality of life of cancer patients(EORTC QLQ-CR29)

    Time frame: 3rd month after recruited

    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.

  12. Quality of life of cancer patients(EORTC QLQ-CR29)

    Time frame: 6rd month after recruited

    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.

  13. Quality of life of cancer patients(EORTC QLQ-CR29)

    Time frame: 12rd month after recruited

    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.

  14. Quality of life of cancer patients(EORTC QLQ-CR29)

    Time frame: 24rd month after recruited

    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.

Secondary outcomes

  1. Brief Fatigue Inventory-Taiwanese (BFI-T)

    Time frame: baseline

    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.

  2. Brief Fatigue Inventory-Taiwanese (BFI-T)

    Time frame: 1rd month after recruited

    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.

  3. Brief Fatigue Inventory-Taiwanese (BFI-T)

    Time frame: 2rd month after recruited

    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.

  4. Brief Fatigue Inventory-Taiwanese (BFI-T)

    Time frame: 3rd month after recruited

    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.

  5. Brief Fatigue Inventory-Taiwanese (BFI-T)

    Time frame: 6rd month after recruited

    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.

  6. Brief Fatigue Inventory-Taiwanese (BFI-T)

    Time frame: 12rd month after recruited

    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.

  7. Brief Fatigue Inventory-Taiwanese (BFI-T)

    Time frame: 24rd month after recruited

    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.

  8. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline

    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.

  9. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 1rd month after recruited

    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.

  10. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 2rd month after recruited

    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.

  11. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 3rd month after recruited

    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.

  12. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 6rd month after recruited

    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.

  13. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 12rd month after recruited

    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.

  14. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 24rd month after recruited

    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.

  15. 3-d Physical Activity Record, 3-dPAR

    Time frame: baseline

    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.

  16. 3-d Physical Activity Record, 3-dPAR

    Time frame: 3rd month after recruited

    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.

  17. 30-second Chair sit-to-stand, 30-s STS

    Time frame: baseline

    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.

  18. 30-second Chair sit-to-stand, 30-s STS

    Time frame: 3rd month after recruited

    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.

  19. Six-Minute Walk Test, 6MWT

    Time frame: baseline

    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.

  20. Six-Minute Walk Test, 6MWT

    Time frame: 3rd month after recruited

    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.

  21. Exercise Counseling and Programming Preferences

    Time frame: baseline

    Exercise preferences were assessed by questions related to exercise counseling and exercise programming.

  22. Exercise Counseling and Programming Preferences

    Time frame: 3rd month after recruited

    Exercise preferences were assessed by questions related to exercise counseling and exercise programming.

  23. Exercise Counseling and Programming Preferences

    Time frame: 6rd month after recruited

    Exercise preferences were assessed by questions related to exercise counseling and exercise programming.

  24. Exercise Counseling and Programming Preferences

    Time frame: 12rd month after recruited

    Exercise preferences were assessed by questions related to exercise counseling and exercise programming.

  25. Exercise Counseling and Programming Preferences

    Time frame: 24rd month after recruited

    Exercise preferences were assessed by questions related to exercise counseling and exercise programming.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Mei Chen, PhD

CONTACT

[email protected]

02-28227101 ext. 3139

Zih-Yun Deng, BSN

CONTACT

[email protected]

0917741835

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital Hsin-Chu Branch

Other

Collaborators

  • National Taipei University of Nursing and Health Sciences

Registry information

Official study title

National Taiwan University Hospital Hsin-Chu Branch.

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Feb 4, 2022
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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