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Recruiting NCT05224518

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

No phase Interventional Colorectal Cancer Fatigue Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: elastic band training.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Fatigue, Quality of Life. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

National Taiwan University Hospital Hsin-Chu Branch.

Overview

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

  • Behavioral elastic band training
    elastic band training include stretching exercises

Primary outcome measures

  • Quality of life of cancer patients(EORTC QLQ-C30) [Time frame: baseline]
  • Quality of life of cancer patients(EORTC QLQ-C30) [Time frame: 1rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-C30) [Time frame: 2rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-C30) [Time frame: 3rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-C30) [Time frame: 6rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-C30) [Time frame: 12rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-C30) [Time frame: 24rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-CR29) [Time frame: baseline]
  • Quality of life of cancer patients(EORTC QLQ-CR29) [Time frame: 1rd month after recruited]
  • Quality of life of cancer patients(EORTC QLQ-CR29) [Time frame: 2rd month after recruited]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Taiwan · 1 center
  • NTU Hsin-Chu Hospital — Hsinchu

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. PMID 8433390
  • 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. PMID 29076609
  • 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. PMID 23851406
  • 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 International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116. PMID 31626055
  • 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. PMID 31626056
  • 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.2017.05.027. Epub 2017 Jun 8. PMID 28651827

Identifiers

NCT: NCT05224518 · 110-146-E

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗