This Trial Corresponds to the Manuscript Titled: Effects of Tai Chi on Balance and Sleep Quality in Colorectal Cancer Patients Undergoing Chemotherapy

Effect of Tai Chi Exercise Intervention on Physical and Mental Distress of Patients With Colorectal Cancer During Adjuvant Chemotherapy

Colorectal cancer patients receiving adjuvant chemotherapy may experience reduced physical fitness, fatigue, emotional distress, sleep problems, and impaired quality of life. This study evaluated whether a 24-week Tai Chi exercise program could improve physical and psychological outcomes in patients with colorectal cancer undergoing adjuvant chemotherapy.

Participants were randomly assigned to either a Tai Chi exercise group or a usual-care control group. Participants in the Tai Chi group were instructed to perform at least 150 minutes of Tai Chi exercise per week for 24 weeks, while participants in the control group received usual care. Physical fitness, fatigue, depression, anxiety, sleep quality, and quality of life were assessed during the study.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Tai Chi Exercise Program

Detailed Description

This study used a randomized, two-group, repeated-measures design to evaluate the effects of a 24-week Tai Chi exercise program in patients with colorectal cancer undergoing adjuvant chemotherapy.

Eligible participants were adults aged 20 years or older who had undergone colorectal cancer surgery for the first time and were scheduled to receive six months of adjuvant chemotherapy. Participants were randomly assigned to the Tai Chi exercise group or the usual-care control group using a computer-generated random-number procedure.

Participants assigned to the intervention group received usual care and participated in a 24-week Tai Chi exercise program. They were instructed to complete at least 150 minutes of Tai Chi exercise per week. The exercise could be completed in one or multiple sessions according to the participant's physical condition and treatment schedule. Participants received an instructional video and manual, recorded their daily exercise duration, and were contacted weekly by telephone to assess adherence and address difficulties encountered during exercise.

Participants assigned to the control group received usual care during adjuvant chemotherapy and did not receive the structured Tai Chi exercise program.

Study outcomes included upper- and lower-extremity muscle strength, static and dynamic balance, fatigue, depression, anxiety, sleep quality, and quality of life. Assessments were conducted before the first adjuvant chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment.

A total of 60 participants were enrolled, including 31 participants assigned to the Tai Chi exercise group and 29 assigned to the usual-care control group. Fifty-three participants completed the study assessments.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan
    • New Taipei City, Taiwan, Taiwan, 251020
      • Tamsui Mackay Memorial Hospital
    • Taipei, Taiwan, Taiwan, 104217
      • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 20 years or older
• Underwent colorectal cancer surgery for the first time
• Scheduled to receive six months of adjuvant chemotherapy following colorectal cancer surgery
• No other serious medical condition
• No acute functional decline during hospitalization
• Willing to participate and able to provide written informed consent after receiving an explanation of the study
• Able to communicate in Mandarin Chinese or Taiwanese
• Clinically stable and receiving regular outpatient follow-up

Exclusion Criteria:

• Required radiotherapy or targeted therapy in addition to adjuvant chemotherapy after surgery
• Admitted to an intensive care unit because of trauma surgery, heart failure, end-stage disease, or another serious condition
• Valvular heart disease, atrial fibrillation, cardiomyopathy, myocarditis, uncontrolled chronic disease, or congestive heart failure
• Unable to clearly communicate level of consciousness, symptoms, or feelings
• Severe visual or hearing impairment
• Diagnosed psychiatric disorder
• Medically advised not to exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tai Chi Exercise Group; Participants received usual care and completed a 24-week Tai Chi exercise program, with a target of at least 150 minutes of Tai Chi exercise per week.	Behavioral: Tai Chi Exercise Program; A 24-week home-based Tai Chi exercise program consisting of slow, low-impact movements, warm-up exercises, muscle-strengthening movements, and cool-down exercises. Participants were instructed to complete at least 150 minutes of Tai Chi exercise per week. The exercise could be completed in one or multiple sessions according to each participant's physical condition and chemotherapy schedule. Participants received an instructional video and manual, recorded their daily exercise duration, and were contacted weekly by telephone to assess adherence and address exercise-related difficulties.
No Intervention: Usual Care Control Group; Participants received usual care during adjuvant chemotherapy and did not receive the structured Tai Chi exercise program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fatigue Measured by the Brief Fatigue Inventory-Taiwan Form	Fatigue was assessed using the Brief Fatigue Inventory-Taiwan Form. The instrument contains three items assessing fatigue severity and six items assessing interference of fatigue with daily functioning. Each item is rated from 0 to 10, with higher scores indicating greater fatigue severity or interference. Mean fatigue severity and fatigue interference scores were calculated.	Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Grip Strength	Upper-extremity muscle strength was assessed using a Camry EH101 electronic handgrip dynamometer. Participants performed the test three times with their dominant hand while standing with their arms naturally positioned at their sides. A rest period of 1 to 2 minutes was provided between measurements. The highest value from the three measurements was recorded in kilograms. Higher values indicate greater grip strength.	Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
Change in Lower-Extremity Muscle Strength Measured by the 30-Second Chair Stand Test	Lower-extremity muscle strength and endurance were assessed using the 30-Second Chair Stand Test. Participants began seated in a 0.43-meter-high chair with their arms crossed over their chest and were instructed to rise to a full standing position and return to a seated position as many times as possible within 30 seconds. The total number of correctly completed stands was recorded. Higher numbers indicate better lower-extremity muscle strength and endurance.	Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
Change in Depression Severity Measured by the Beck Depression Inventory-II	Depressive symptoms were assessed using the Chinese version of the Beck Depression Inventory-II (BDI-II). The instrument contains 21 items assessing cognitive, affective, and somatic symptoms of depression. Each item is rated from 0 to 3, producing a total score ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms.	Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
Change in Anxiety Severity Measured by the Beck Anxiety Inventory	Anxiety symptoms were assessed using the Chinese version of the Beck Anxiety Inventory (BAI). The instrument contains 21 items assessing subjective anxiety, panic-related symptoms, and somatic symptoms of anxiety. Each item is rated from 0 to 3, producing a total score ranging from 0 to 63. Higher scores indicate greater severity of anxiety symptoms.	Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
Change in Sleep Quality Measured by the Pittsburgh Sleep Quality Index	Sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). The instrument contains 19 self-rated items that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, producing a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality.	Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
Change in Health-Related Quality of Life Measured by the EORTC QLQ-C30	Health-related quality of life was assessed using the Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 30-item instrument includes five functional scales, three symptom scales, six single-item symptom measures, and a global health status/quality-of-life scale. Scale scores range from 0 to 100. Higher scores on the functional and global health status/quality-of-life scales indicate better functioning and quality of life, whereas higher scores on the symptom scales and single-item measures indicate greater symptom burden.	Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks

Collaborators and Investigators

• Sponsor: Ya-Fen Fan
• Collaborators: Mackay Memorial Hospital; Hungkuang University

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2020
• Primary Completion (Actual): December 29, 2022
• Study Completion (Actual): December 29, 2022

Study Registration Dates

• First Submitted: September 16, 2026
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 22, 2026

Study Record Updates

• Last Update Posted (Actual): September 22, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Balance; Quality of Life; Anxiety; Fatigue; Tai Chi; Sleep Quality; Physical Fitness; Adjuvant Chemotherapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Neoplasms by Site; Neoplasms; Intestinal Diseases; Behavioral Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Anxiety Disorders; Colorectal Neoplasms; Depression; Fatigue; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 20MMHIS382e; 20MMHIS382e (Other Identifier: Mackay Memorial Hospital Institutional Review Board approval number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual participant data will not be shared because the informed consent obtained from participants did not include authorization for public or external sharing of individual-level data. Data sharing is also restricted to protect participant privacy and confidentiality in accordance with the approved study protocol and institutional review board requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No