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NCT Number: NCT07833358

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

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Key information

Conditions

Colorectal Cancer Anxiety Disorders Behavior Behavioral Symptoms Colonic Diseases Colorectal Neoplasms Depression Digestive System Diseases Digestive System Neoplasms Dyssomnias Fatigue Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tamsui Mackay Memorial Hospital, New Taipei City, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Fatigue Measured by the Brief Fatigue Inventory-Taiwan Form

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

    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.

Secondary outcomes

  1. Change in Grip Strength

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

    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.

  2. Change in Lower-Extremity Muscle Strength Measured by the 30-Second Chair Stand Test

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

    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.

  3. Change in Depression Severity Measured by the Beck Depression Inventory-II

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

    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.

  4. Change in Anxiety Severity Measured by the Beck Anxiety Inventory

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

    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.

  5. Change in Sleep Quality Measured by the Pittsburgh Sleep Quality Index

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

    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.

  6. Change in Health-Related Quality of Life Measured by the EORTC QLQ-C30

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

    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.

Sponsors and collaborators

Lead sponsor

Ya-Fen Fan

Other

Collaborators

  • Hungkuang University
  • Mackay Memorial Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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