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- Klinische proef NCT02665130
Comparison of Tai Chi and Pulmonary Rehabilitation on the Effect of Indacaterol in Treatment naïve COPD Participants
State Key Laboratory of Respiratory Disease
Tai-Chi may be a beneficial form of rehabilitation which is acceptable to the Chinese population but no data exist concerning metabolic responses to Tai-Chi in COPD patients. Investigators conduct an Randomized controlled trial to evaluate the synergistic effect of a Long acting β2-agonists with Tai-Chi as a culturally acceptable form of PR in the Asian population. Classical western style pulmonary rehabilitation will serve as a comparator Investigators propose a prospective randomized controlled trial in which 120 bronchodilator naïve participants (Age 40-80 with GOLD II-IV COPD (post-bronchodilator FEV1 ≥ 25% and <80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70) are randomized to receive a 26 weeks course of Indacaterol with either Tai-Chi or conventional Pulmonary Rehabilitation. Only participants who are residents in Xingning city (Guangdong Province, China) will be recruited.
Both Tai-Chi and pulmonary rehabilitation will be given by qualified instructors at a rural location in southern China (Xingning). A qualified UK Physiotherapist will also be involved in the management of pulmonary rehabilitation program to further make sure the high quality of pulmonary rehabilitation has been applied. Both arm participants will also receive in an open label fashion Indacaterol 150µg qd. for 6 months giving 2 therapy groups (Tai-Chi/Indacaterol, pulmonary rehabilitation/Indacaterol). The primary endpoint of this study is change in SGRQ between Tai-Chi/Indacaterol and pulmonary rehabilitation/Indacaterol at 14 weeks after entry and the secondary endpoints are change in FEV1% and six minute walk distance. the planned recruitment will be 120 with a view to obtaining 100 completers. The investigators propose the study starts on 31 Dec 2014 and completes on 30 June, 2016.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Guangdong
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Meizhou, Guangdong, China
- Xing-Ning Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- bronchodilator naïve patients
- Age 40-80 with GOLD II-IV COPD (post-bronchodilator FEV1 ≥ 25% and <80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70)
- patients who are residents in Xingning city (Guangdong Province, China) will be recruited.
Exclusion Criteria:
- Patients currently or previous on any type of Tai Chi exercise or pulmonary rehabilitation
- Patients with a history of malignancy of any organ system treated or untreated, within the past 5 years.
- Patients with clinically significant renal, cardiovascular, neurological, metabolism, immunological, psychiatric, gastrointestinal, hepatic, or haematological abnormalities.
- Patients with concomitant pulmonary disease (e.g. asthma, lung fibrosis, primary bronchiectasis, sarcoidosis, interstitial lung disorder, tuberculosis)
- Patients with obesity (BMI> 40 kg/m2).
- Patients requiring long term oxygen therapy (> 12 h a day) on a daily basis for chronic hypoxemia or recovering from acute exacerbation less than 6 weeks.
- Patients with Asthma.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Tai-Chi group
Tai-Chi exercise plus Indacaterol 150ug/day
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Participants perform Tai-chi exercise 5 days/week and take indacaterol 150ug/day for 24 weeks
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Placebo-vergelijker: Pulmonary rehabilitation group
Conventional exercise plus Indacaterol 150ug/day
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Participants perform conventional exercise 5 days/week and take indacaterol 150ug/day for 24 weeks
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
change in St. George's Respiratory Questionnaire (SGRQ)
Tijdsspanne: 14 weeks after intervention
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14 weeks after intervention
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Yuan-Ming Luo, PhD, The Affiliated Hospital og Guangzhou Medical University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CQAB149BCN01T
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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Klinische onderzoeken op Tai-chi plus Indacaterol
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Federal University of PelotasNog niet aan het werven
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Harvard University Faculty of MedicineBeth Israel Deaconess Medical Center; Brigham and Women's HospitalVoltooid
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Lidian ChenPeking University Third HospitalNog niet aan het werven
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Chengdu University of Traditional Chinese MedicineNog niet aan het wervenKwaliteit van het leven | Dialyse; complicaties | Chinees medicijn
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University Hospital, Clermont-FerrandVoltooid
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Hartford HospitalWerving
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Chang Gung Memorial HospitalVoltooid
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Texas Tech University Health Sciences CenterActief, niet wervend
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Massachusetts General HospitalOnbekend
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Chen Li TienVoltooid