- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Jakarta Special Capital Region
-
Jakarta, Jakarta Special Capital Region, Indonesien, 11420
- Dharmais Cancer Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Reduced Fatigue
Tidsramme: 3 Weeks
|
Reduced Fatigue Scores
|
3 Weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 077/KEPK/II (Registry Identifier: Dharmais Cancer Hospital)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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