- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07702409
Tai-Chi Exercise Reduces Fatigue in Breast Cancer Patients Undergoing Chemotherapy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research process was guided by the CONSORT Statement for RCTs. The process involved registration, allocation, follow-up, and analysis. The recruitment process began with a feasibility assessment for potential respondents. This process was carried out when the patient conducted a phase 2 rehabilitation evaluation. Researchers initially reviewed patient data through medical records, reviewing ID, color code, age, gender, medical history, patient condition, and location of residence. Patients' communication skills were assessed during the evaluation.
This study used a randomized clinical trial design with a pre-post-test with control group approach. The inclusion criteria for the study sample were conscious and cooperative patients (compos mentis), patients with a good condition, breast cancer patients undergoing chemotherapy, aged 18-64 years, stage 0-III, having an electronic cell phone or laptop, and willing to participate. The exclusion criteria in this study were patients with mental illness or severe cognitive impairment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jakarta Special Capital Region
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Jakarta, Jakarta Special Capital Region, Indonesia, 11420
- Dharmais Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The inclusion criteria for the study sample were conscious and cooperative patients (compos mentis), patients with a good condition, breast cancer patients undergoing chemotherapy, aged 18-64 years, stage 0-III, having an electronic cell phone or laptop, and willing to participate.
Exclusion Criteria:
- The exclusion criteria in this study were patients with mental illness or severe cognitive impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Performed Tai-Chi
|
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. |
|
Experimental: Control Group
Performed Daily Physical Activities
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduced Fatigue
Time Frame: 3 Weeks
|
Reduced Fatigue Scores
|
3 Weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 077/KEPK/II (Registry Identifier: Dharmais Cancer Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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