NCT07702409

Brief Summary

Tai-Chi Exercise Reduces Fatigue in Breast Cancer Patients Undergoing Chemotherapy. The main question it aims to answer is: Does Tai-chi training reduce fatigue in breast cancer patients? Participants performed the exercise on the day agreed upon with the researcher. All participants were given routine care, and leaflets related to chemotherapy, psychological aspects of cancer patients, nutrition, and management of cancer symptoms. While respondents in the intervention group received 5 times Tai-Chi practice interventions in a week for 3 weeks with a duration of 30 minutes of each practice, using 18 forms of Tai-Chi shibashi adapted from Yang's style. Before the Tai-Chi intervention is implemented, standard training was given once to each respondent by an experienced Tai-Chi master, as well as video tutorials for independent practice at home demonstrated by the Tai-Chi master. During the three weeks of practicing Tai-Chi at home, each respondent was asked to fill out a logbook for each exercise, and fill out a fatigue questionnaire every three days, while the control group was asked to fill out their daily physical activities reports on the logbook. The researcher invited the intervention group respondents to the WhatsApp Group to remind the participants to practice the Tai-Chi exercise at home every day, evaluate side effects during exercise and fill out a fatigue questionnaire in the logbook. The researcher also invited control group respondents to the WhatsApp Group to remind participants to fill in their daily physical activities and fill out fatigue questionnaires in the logbook. Research respondents who met the inclusion criteria were randomized by research assistants using block randomization with sorted random tables, the order of randomization was kept by research assistants who were not directly involved in the study. After the respondents who met the requirements were identified and completed the pre-test, the researcher contacted the research assistant to place the respondents in the intervention or control group according to a pre-determined randomization sequence. Due to the observable nature of Tai-Chi practice, the lack of a sham comparison group, and the pre-test and post-test measurements reported by the respondents, blindness could not be performed on the respondents. Data collection and follow-up is carried out every 3 days via chat or telephone. Based on the initial sample count, there were 23 respondents in each group (n = 46), and to cover the possibility of 25% drop-out respondents, the correction for the sample size of this study was 61 respondents, 31 respondents in the intervention group, 30 respondents in the control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2026

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 9, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

Breast CancerBreast Cancer and rehabilitationTai-Chi ExerciseReduces FatigueChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Reduced Fatigue

    Reduced Fatigue Scores

    3 Weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Performed Tai-Chi

Behavioral: Tai-chi

Control Group

EXPERIMENTAL

Performed Daily Physical Activities

Behavioral: Daily Physical Activities

Interventions

Tai-chiBEHAVIORAL

All participants were given routine care, and leaflets related to chemotherapy, psychological aspects of cancer patients, nutrition, and management of cancer symptoms. While respondents in the intervention group received 5 times Tai-Chi practice interventions in a week for 3 weeks with a duration of 30 minutes of each practice, using 18 forms of Tai-Chi shibashi adapted from Yang's style. Before the Tai-Chi intervention is implemented, standard training was given once to each respondent by an experienced Tai-Chi master, as well as video tutorials for independent practice at home demonstrated by the Tai-Chi master. During the three weeks of practicing Tai-Chi at home, each respondent was asked to fill out a logbook for each exercise, and fill out a fatigue questionnaire every three days. The researcher invited the intervention group respondents to the WhatsApp Group to remind the participants to practice the Tai-Chi exercise at home every day, evaluate side effects during exercise.

Intervention Group

All participants were given routine care, and leaflets related to chemotherapy, psychological aspects of cancer patients, nutrition, and management of cancer symptoms. While the control group was asked to fill out their daily physical activities reports on the logbook. The researcher also invited control group respondents to the WhatsApp Group to remind participants to fill in their daily physical activities and fill out fatigue questionnaires in the logbook.

Control Group

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dharmais Cancer Hospital

Jakarta, Jakarta Special Capital Region, 11420, Indonesia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were not involved during the intervention process. Respondents were also asked not to inform the outcome assessor of the measures they received.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ns. Chairul Huda, S.Kep., M.Kep., Sp.Kep.M.B

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 14, 2026

Study Start

March 20, 2026

Primary Completion

May 28, 2026

Study Completion

June 15, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations