Colorectal CancerNCT05224518
Exercise Intervention to Improve Quality of Life in Patients With Colorectal Cancer
A study testing elastic band training in people with Colorectal Cancer and Fatigue, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer, Fatigue, Quality of Life
- What is being tested?
- elastic band training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Feb 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
NTU Hsin-Chu Hospital
Hsinchu, 300
Zih-Yun Deng, 0917741835, debby820130@gmail.com
About this study
Official title: National Taiwan University Hospital Hsin-Chu Branch.
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.
- Explore the effect of "12-week home exercise intervention" in improving the fatigue of colorectal cancer patients.
- Explore the effect of "12-week home exercise intervention" in improving the sleep quality of patients with colorectal cancer.
- Explore the effect of "12-week home exercise intervention" in improving the muscle endurance of patients with colorectal cancer.
- Explore the effect of "12-week home exercise intervention" in improving the quality of life of colorectal cancer patients.
Read the detailed 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.
- Conditions
- Colorectal Cancer, Fatigue, Quality of Life
- Being tested
- elastic band training
- Keywords
- elastic band training, colorectal cancer, exercises
- Medical subject headings
- Colorectal Neoplasms, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastic band trainingBehavioural
Also called stretching exercises
elastic band training include stretching exercises
| Study group | Role | What they receive |
|---|---|---|
| home-based elastic band training group | Experimental | The interventional group received 12 weeks of home-based elastic band training, three days a week, with progressive, medium-intensity exercise. Receives: Behavioral: elastic band training |
| stretching exercises group | Active comparator | The control group received home stretching exercises three days a week for 12 weeks. Receives: Behavioral: elastic band training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24rd month after recruited
Secondary outcomes (25)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 3rd month after recruited
Exercise Counseling and Programming Preferences
Exercise preferences were assessed by questions related to exercise counseling and exercise programming.
Measured: baseline
Exercise Counseling and Programming Preferences
Exercise preferences were assessed by questions related to exercise counseling and exercise programming.
Measured: 3rd month after recruited
Exercise Counseling and Programming Preferences
Exercise preferences were assessed by questions related to exercise counseling and exercise programming.
Measured: 6rd month after recruited
Exercise Counseling and Programming Preferences
Exercise preferences were assessed by questions related to exercise counseling and exercise programming.
Measured: 12rd month after recruited
Exercise Counseling and Programming Preferences
Exercise preferences were assessed by questions related to exercise counseling and exercise programming.
Measured: 24rd month after recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start21 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Responsible party
- Sponsor
- Investigators
- Hui-Mei Chen, Study chair, University of Nursing and Health Sciences, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224518
- Sponsor's protocol ID
- 110-146-E
- Status last verified
- Mar 2024
- First submitted
- 12 Dec 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de identification (text, tables, figures, and appendices).
Publications
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.
PubMed 8433390Chen 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.
PubMed 29076609Thompson 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.
PubMed 23851406Campbell 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.
PubMed 31626055Patel 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.
PubMed 31626056Uster 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.
PubMed 28651827
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taiwan University Hospital Hsin-Chu Branch.
- ClinicalTrials.gov ID
- NCT05224518
- Acronym / sponsor ID
- 110-146-E
- Conditions
- Colorectal Cancer, Fatigue, Quality of Life
- Keywords
- elastic band training, colorectal cancer, exercises
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Explore the effect of "12-week home exercise intervention" in improving the fatigue of colorectal cancer patients.
- Explore the effect of "12-week home exercise intervention" in improving the sleep quality of patients with colorectal cancer.
- Explore the effect of "12-week home exercise intervention" in improving the muscle endurance of patients with colorectal cancer.
- Explore the effect of "12-week home exercise intervention" in improving the quality of life of colorectal cancer patients.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| home-based elastic band training group | Experimental | Behavioral: elastic band trainingThe interventional group received 12 weeks of home-based elastic band training, three days a week, with progressive, medium-intensity exercise. |
| stretching exercises group | Active comparator | Behavioral: elastic band trainingThe control group received home stretching exercises three days a week for 12 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elastic band trainingAlso: stretching exerciseselastic band training include stretching exercises | Behavioural | home-based elastic band training group, stretching exercises group |
Primary outcome
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
25 secondary outcomes
Brief Fatigue Inventory-Taiwanese (BFI-T)
Time frame: baseline
Brief Fatigue Inventory-Taiwanese (BFI-T)
Time frame: 1rd month after recruited
Brief Fatigue Inventory-Taiwanese (BFI-T)
Time frame: 2rd month after recruited
Brief Fatigue Inventory-Taiwanese (BFI-T)
Time frame: 3rd month after recruited
Brief Fatigue Inventory-Taiwanese (BFI-T)
Time frame: 6rd month after recruited
Brief Fatigue Inventory-Taiwanese (BFI-T)
Time frame: 12rd month after recruited
Brief Fatigue Inventory-Taiwanese (BFI-T)
Time frame: 24rd month after recruited
Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1rd month after recruited
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 2rd month after recruited
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3rd month after recruited
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6rd month after recruited
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12rd month after recruited
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 24rd month after recruited
3-d Physical Activity Record, 3-dPAR
Time frame: baseline
3-d Physical Activity Record, 3-dPAR
Time frame: 3rd month after recruited
30-second Chair sit-to-stand, 30-s STS
Time frame: baseline
30-second Chair sit-to-stand, 30-s STS
Time frame: 3rd month after recruited
Six-Minute Walk Test, 6MWT
Time frame: baseline
Six-Minute Walk Test, 6MWT
Time frame: 3rd month after recruited
Exercise Counseling and Programming Preferences
Time frame: baseline
Exercise Counseling and Programming Preferences
Time frame: 3rd month after recruited
Exercise Counseling and Programming Preferences
Time frame: 6rd month after recruited
Exercise Counseling and Programming Preferences
Time frame: 12rd month after recruited
Exercise Counseling and Programming Preferences
Time frame: 24rd month after recruited
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 8433390Aaronson 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.
- Background: PubMed 29076609Chen 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.
- Background: PubMed 23851406Thompson 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.
- Results publication: PubMed 31626055Campbell 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.
- Results publication: PubMed 31626056Patel 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.
- Results publication: PubMed 28651827Uster 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.
- National cancer institute.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de identification (text, tables, figures, and appendices).
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui-Mei Chen study chair
University of Nursing and Health Sciences, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing elastic band training in people with Colorectal Cancer and Fatigue, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zih-Yun Deng, BSN (0917741835, debby820130@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of cancer patients(EORTC QLQ-C30) (time frame: baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05224518, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.