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

NCT ID: NCT05224518

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-21

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Colorectal Cancer Fatigue Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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home-based elastic band training group

The interventional group received 12 weeks of home-based elastic band training, three days a week, with progressive, medium-intensity exercise.

Group Type EXPERIMENTAL

elastic band training

Intervention Type BEHAVIORAL

elastic band training include stretching exercises

stretching exercises group

The control group received home stretching exercises three days a week for 12 weeks.

Group Type ACTIVE_COMPARATOR

elastic band training

Intervention Type BEHAVIORAL

elastic band training include stretching exercises

Interventions

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elastic band training

elastic band training include stretching exercises

Intervention Type BEHAVIORAL

Other Intervention Names

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stretching exercises

Eligibility Criteria

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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.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role collaborator

National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hui-Mei Chen

Role: STUDY_CHAIR

University of Nursing and Health Sciences, Taipei, Taiwan

Locations

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NTU Hsin-Chu Hospital

Hsinchu, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Zih-Yun Deng, BSN

Role: CONTACT

0917741835

Hui-Mei Chen, PhD

Role: CONTACT

02-28227101 ext. 3139

Facility Contacts

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Zih-Yun Deng

Role: primary

0917741835

References

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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.

Reference Type BACKGROUND
PMID: 8433390 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29076609 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23851406 (View on PubMed)

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.

Reference Type RESULT
PMID: 31626055 (View on PubMed)

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.

Reference Type RESULT
PMID: 31626056 (View on PubMed)

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.

Reference Type RESULT
PMID: 28651827 (View on PubMed)

Related Links

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Other Identifiers

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110-146-E

Identifier Type: -

Identifier Source: org_study_id

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