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

National Taiwan University Hospital Hsin-Chu Branch.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05224518
Enrollment
106
Registered
2022-02-04
Start date
2022-02-21
Completion date
2027-12-31
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Fatigue, Quality of Life

Keywords

elastic band training, colorectal cancer, exercises

Brief 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.

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.

Interventions

elastic band training include stretching exercises

Sponsors

National Taipei University of Nursing and Health Sciences
CollaboratorOTHER
National Taiwan University Hospital Hsin-Chu Branch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of life of cancer patients(EORTC QLQ-C30)baselineThis 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)baselineThe 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

MeasureTime frameDescription
3-d Physical Activity Record, 3-dPARbaselineDeveloped 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.
30-second Chair sit-to-stand, 30-s STSbaselineAbility 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.
Brief Fatigue Inventory-Taiwanese (BFI-T)baselineThe 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.
Exercise Counseling and Programming PreferencesbaselineExercise preferences were assessed by questions related to exercise counseling and exercise programming.
Six-Minute Walk Test, 6MWTbaselineFunctional 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.
Pittsburgh Sleep Quality Index (PSQI)baselineThe 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.

Countries

Taiwan

Contacts

Primary ContactZih-Yun Deng, BSN
debby820130@gmail.com0917741835
Backup ContactHui-Mei Chen, PhD
alice@ntunhs.edu.tw02-28227101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026