ClinicalTrials.gg
CompletedNCT07833358Updated Sep 22, 2026

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

An interventional study of Tai Chi Exercise Program in Colorectal Cancer, sponsored by Ya-Fen Fan. Completed at 2 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Ya-Fen Fan · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 years 8 months after the study started (first participant enrolled Dec 2020, registered Sep 2026).

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 165 studies in Colorectal Neoplasms with a site in Taiwan — 33 open to participants now, 53 under way, 11 of them phase 3. Colorectal Neoplasms · Taiwan.

Enrollment
114th of 137
60 · median 209
Started
2020
with 12 others
No phase
30 of 165
7 open now
Registered
165th of 165
by date

Among the 165 studies in Colorectal Neoplasms with a site in Taiwan, this one is the 114th largest by enrollment of the 137 interventional ones that give a count, is one of 13 that started in 2020, is one of 30 with no phase, and was the 165th registered.

Colorectal Neoplasms

6,544 studies on the registry are indexed under Colorectal Neoplasms; 1,666 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

33 of the 165 studies in Colorectal Neoplasms with a site in Taiwan are open now. Recruiting first, the newest first:

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All 33 open studies →

A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →

Who these studies take

Of the 1,184 Colorectal Neoplasms studies recruiting now, 767 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 124 take healthy volunteers.

This study: 20 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Colorectal Cancer

Keywords

  • Tai Chi
  • Adjuvant Chemotherapy
  • Physical Fitness
  • Balance
  • Sleep Quality
  • Fatigue
  • Depression
  • Anxiety
  • Quality of Life
04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 20 years or older
  • Underwent colorectal cancer surgery for the first time
  • Scheduled to receive six months of chemotherapy following colorectal cancer surgery
  • No other serious medical condition
  • No acute functional decline during hospitalization
  • Willing to participate and able to provide written 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

Exclusion Criteria:

  • Required radiotherapy or targeted therapy in addition to 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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

  • No intervention
    Usual Care Control Group

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

Interventions

  • BehavioralTai 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.

06

What researchers measure

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.

    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

Secondary outcomes

  1. 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.

    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

  2. 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.

    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

  3. 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.

    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

  4. 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.

    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

  5. 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.

    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

  6. 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.

    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

07

Study locations

2 sites
  • Tamsui Mackay Memorial Hospital
    New Taipei City, Taiwan 251020, Taiwan
  • Mackay Memorial Hospital
    Taipei, Taiwan 104217, Taiwan
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2020 to primary completion in Dec 2022, 23 months.

Of 899 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's 23 months is below that.

Counting every sponsor, half of 956 studies reached it within 32 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2026
First posted
Sep 22, 2026
StartActual
Dec 30, 2020
Primary completionActual
Dec 29, 2022
CompletionActual
Dec 29, 2022
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07833358
Lead sponsor
Ya-Fen Fan
Collaborators
Mackay Memorial Hospital, Hungkuang University
Responsible party
Ya-Fen Fan (Assistant Professor, Department of Nursing, MacKay Junior College of Medicine, Nursing, and Management) — Sponsor-investigator
First posted
Sep 22, 2026
Start date
Dec 30, 2020
Primary completion
Dec 29, 2022
Completion
Dec 29, 2022
Last update
Sep 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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