- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05159167
Impact of Baduanjin Qigong Exercise on Fatigue in Patients With NSCLC Undergoing Adjuvant Chemotherapy
3. december 2021 opdateret af: Yu Qian, Hubei Cancer Hospital
Impact of Baduanjin Qigong Exercise on Fatigue in Patients With Non Small Cell Lung Cancer Undergoing Adjuvant Chemotherapy: A Randomized Controlled Trial
Baduanjin,a type of Qigong which belongs to aerobic exercise, is very popular in China.
There is increasing evidence to support its positive effects on health outcomes in various groups of people with physical and mental disorders.
In college students, it may enhance cardio respiratory function, lower limb function, and flexibility compared with usual exercise.
However, there is no previous relevant randomized controlled trials on the health promoting effects of Baduanjin exercise in targeted fatigued lung cancer patients.
Lung cancer survivors can experience fatigue due to multiple reasons that can strongly impact their quality of life throughout the remainder of their life.
Therefore, this randomized controlled trial in China was designed to assess the health promoting effects of Baduanjin exercise in fatigued lung cancer patients with the expectation of improvement in physical and psychological health.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yu Qian, Dr
- Telefonnummer: +862787670255
- E-mail: 173653835@qq.com
Studiesteder
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Hubei
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Wuhan, Hubei, Kina, 430000
- Rekruttering
- Hubei Cancer Hospital
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Kontakt:
- Yuan Wu, Dr.
- Telefonnummer: 027-87670318
- E-mail: gwgfe@163.com
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- This trial aims to enroll 18- to 75-year-old patients expected to survive > 3 months and with a Zubrod performance status of 0 to 2. All patients must have diagnosed as lung cancer and have at least one cycle of adjuvant chemotherapy. Enrolled patients should have a minimal ESAS fatigue as 3. Other inclusion criteria are lack of leptomeningeal disease, adequate hepatorenal function and blood counts (red blood cells, >3.0 * 1012/L; white blood cells, > 3.5 * 109/L; absolute neutrophil count, > 1.5 * 109/L; platelets, > 100 * 109/L; hemoglobin > 90 g/L).
Exclusion Criteria:
- Children
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Intervention group
Participants in the intervention group received two months of Baduanjin exercise training provided by the specialist coach 3 days per week in Hubei Cancer Hospital, and they were also required to do Baduanjin exercise at home for the remaining 4 days each week for at least 20 min per day.
All the participants are requested to monitor and record adverse effects during their exercise sessions.
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Baduanjin is very popular in China.
There is increasing evidence to support its positive effects on health outcomes in various groups of people with physical and mental disorders.
|
Placebo komparator: Control group
Participants in the control group were requested to maintain their original daily physical activity for no less than 20 min per day over the following 6-month period and record their daily activity at home by themselves.
These data were collected by a researcher during the participants' time in the study and at the 6-month follow-up at the hospital.
After the 6-month follow-up, the participants were provided with 1-month professional Baduanjin exercise guidance by the trial's specialist coach for free if they wished.
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Baduanjin is very popular in China.
There is increasing evidence to support its positive effects on health outcomes in various groups of people with physical and mental disorders.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Scale of fatigue
Tidsramme: 6 months
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Yuan Wu, Huazhong University of Science and Technology
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. december 2021
Primær færdiggørelse (Forventet)
1. august 2022
Studieafslutning (Forventet)
1. august 2023
Datoer for studieregistrering
Først indsendt
1. december 2021
Først indsendt, der opfyldte QC-kriterier
3. december 2021
Først opslået (Faktiske)
16. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. december 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. december 2021
Sidst verificeret
1. december 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LLHBCH2021YN-029
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Baduanjin, a type of Qigong
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University of HoustonBrigham and Women's Hospital; Texas Woman's UniversityAktiv, ikke rekrutterendeLivskvalitet | Fysisk funktion | Pårørende nødForenede Stater
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Huimin GongUkendtDepression | Angst | KOLKina
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Akdeniz UniversityAfsluttetLivskvalitet | Postoperativ smerte | Muskelsvaghed | Smerter, skulder | Tab af respiratorisk funktion | FugevedhæftningKalkun
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The Hong Kong Polytechnic UniversityRekruttering
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The University of Hong KongRekrutteringKræft | Skrøbelighed | Ældre | OverlevelseHong Kong
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The University of Hong KongRekrutteringKræft | Kemoterapi-induceret perifer neuropatiHong Kong
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The University of Hong KongUkendt
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Medical University of GrazAfsluttetPersonligt beskyttelsesudstyr | VarmestressØstrig
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Swansea UniversityAfsluttetA Bite of ACT' (BOA) Accept og Commitment Therapy Online Psykoeducation Kursus | En ventelistekontrolDet Forenede Kongerige
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Horizon Health NetworkUniversity of Manitoba; University of British Columbia; University of Michigan og andre samarbejdspartnereAfsluttetStød | Hypotension | Point of Care UltralydCanada, Sydafrika