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

NCT07833358 | Completed

• 1 other identifier: 20MMHIS382e
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

Tai Chi; Adjuvant Chemotherapy; Physical Fitness; Balance; Sleep Quality; Fatigue; Depression; Anxiety; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in 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

  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

  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

  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

  Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks

Study Arms (2)

Tai Chi Exercise Group

EXPERIMENTAL

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

Usual Care Control Group

NO INTERVENTION

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

Interventions

Tai Chi Exercise Program BEHAVIORAL

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.

Tai Chi Exercise Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ya-Fen Fan: lead
• Mackay Memorial Hospital: collaborator
• Hungkuang University: collaborator

Study Sites (2)

Tamsui Mackay Memorial Hospital

New Taipei City, Taiwan, 251020, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan, 104217, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Sleep Initiation and Maintenance Disorders; Fatigue; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Nursing

Model Details: Participants were randomly assigned to either a 24-week Tai Chi exercise group or a usual-care control group and remained in their assigned group throughout the study.

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: December 30, 2020
• Primary Completion: December 29, 2022
• Study Completion: December 29, 2022
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)