Clinical trial NCT05224518: Exercise Intervention to Improve Quality of Life in Patients With Colorectal Cancer
Official title: National Taiwan University Hospital Hsin-Chu Branch.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Fatigue
Quality of Life
Keywords: elastic band training
colorectal cancer
exercises
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
Collaborators: name: National Taipei University of Nursing and Health Sciences
First posted: 2022-02-04
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Quality of life of cancer patients(EORTC QLQ-C30)
timeFrame: baseline
measure: Quality of life of cancer patients(EORTC QLQ-C30)
timeFrame: 1rd month after recruited
measure: Quality of life of cancer patients(EORTC QLQ-C30)
timeFrame: 2rd month after recruited
measure: Quality of life of cancer patients(EORTC QLQ-C30)
timeFrame: 3rd month after recruited
measure: Quality of life of cancer patients(EORTC QLQ-C30)
timeFrame: 6rd month after recruited
measure: Quality of life of cancer patients(EORTC QLQ-C30)
timeFrame: 12rd month after recruited
measure: Quality of life of cancer patients(EORTC QLQ-C30)
timeFrame: 24rd month after recruited
measure: Quality of life of cancer patients(EORTC QLQ-CR29)
timeFrame: baseline
measure: Quality of life of cancer patients(EORTC QLQ-CR29)
timeFrame: 1rd month after recruited
measure: Quality of life of cancer patients(EORTC QLQ-CR29)
timeFrame: 2rd month after recruited
measure: Quality of life of cancer patients(EORTC QLQ-CR29)
timeFrame: 3rd month after recruited
measure: Quality of life of cancer patients(EORTC QLQ-CR29)
timeFrame: 6rd month after recruited
measure: Quality of life of cancer patients(EORTC QLQ-CR29)
timeFrame: 12rd month after recruited
measure: Quality of life of cancer patients(EORTC QLQ-CR29)
timeFrame: 24rd month after recruited
Secondary outcomes:
measure: Brief Fatigue Inventory-Taiwanese (BFI-T)
timeFrame: baseline
measure: Brief Fatigue Inventory-Taiwanese (BFI-T)
timeFrame: 1rd month after recruited
measure: Brief Fatigue Inventory-Taiwanese (BFI-T)
timeFrame: 2rd month after recruited
measure: Brief Fatigue Inventory-Taiwanese (BFI-T)
timeFrame: 3rd month after recruited
measure: Brief Fatigue Inventory-Taiwanese (BFI-T)
timeFrame: 6rd month after recruited
measure: Brief Fatigue Inventory-Taiwanese (BFI-T)
timeFrame: 12rd month after recruited
measure: Brief Fatigue Inventory-Taiwanese (BFI-T)
timeFrame: 24rd month after recruited
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1rd month after recruited
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2rd month after recruited
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3rd month after recruited
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6rd month after recruited
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12rd month after recruited
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 24rd month after recruited
measure: 3-d Physical Activity Record, 3-dPAR
timeFrame: baseline
measure: 3-d Physical Activity Record, 3-dPAR
timeFrame: 3rd month after recruited
measure: 30-second Chair sit-to-stand, 30-s STS
timeFrame: baseline
measure: 30-second Chair sit-to-stand, 30-s STS
timeFrame: 3rd month after recruited
measure: Six-Minute Walk Test, 6MWT
timeFrame: baseline
measure: Six-Minute Walk Test, 6MWT
timeFrame: 3rd month after recruited
measure: Exercise Counseling and Programming Preferences
timeFrame: baseline
measure: Exercise Counseling and Programming Preferences
timeFrame: 3rd month after recruited
measure: Exercise Counseling and Programming Preferences
timeFrame: 6rd month after recruited
measure: Exercise Counseling and Programming Preferences
timeFrame: 12rd month after recruited
measure: Exercise Counseling and Programming Preferences
timeFrame: 24rd month after recruited
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: NTU Hsin-Chu Hospital
Study officials:
affiliation: University of Nursing and Health Sciences, Taipei, Taiwan
name: Hui-Mei Chen
role: STUDY_CHAIR
References:
citation: Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
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citation: Patel AV, Friedenreich CM, Moore SC, Hayes SC, Silver JK, Campbell KL, Winters-Stone K, Gerber LH, George SM, Fulton JE, Denlinger C, Morris GS, Hue T, Schmitz KH, Matthews CE. American College of Sports Medicine Roundtable Report on Physical Activity, Sedentary Behavior, and Cancer Prevention and Control. Med Sci Sports Exerc. 2019 Nov;51(11):2391-2402. doi: 10.1249/MSS.0000000000002117.
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