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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01112943 |
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Date of registration:
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26/04/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?
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Scientific title:
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The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01112943 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Richard W Costello, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beaumont Hospital |
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Name:
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Brona Fullen, DR |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of College, Dublin |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A diagnosis of COPD based on the GOLD staging of the disease
- Medical Research Council Score of 3 or Above
- Ability of mobilize independently
- Motivated to exercise independently
Exclusion Criteria:
- No evidence of COPD on spirometry
- Acute exacerbation within 4-6 weeks
- Evidence of Ischemic Heat Disease/acute changes on ECG
- Uncontrolled hypertension
- Insulin dependent diabetic
- Inability to exercise independently or musculoskeletal/neurological conditions which
would prevent completion of the course
- Fear of needles
- Lung Cancer
- Previous attendance at pulmonary rehabilitation
Age minimum:
35 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Obstructive Pulmonary Disease
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Intervention(s)
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Other: Acupuncture
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Other: Pulmonary Rehabilitation
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Primary Outcome(s)
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Quality of life score, St George's Quality of Life score
[Time Frame: Initial, 8 weeks and 3 months]
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Secondary Outcome(s)
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'Free Living' Activity Levels
[Time Frame: Initial, 8weeks and 3 months]
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6 minute walk test
[Time Frame: Initial, 8 weeks and three months]
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EuroQol 5D
[Time Frame: Initial, 8 weeks and 3 months]
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BODE Index
[Time Frame: Initial, 8 weeks and 3 months]
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Incremental Shuttle Walk Test
[Time Frame: Initial, 8 weeks and 3 months]
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Inflammatory Markers
[Time Frame: Initial, 8 weeks and 3 monts]
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St. George's Respiratory Questionnaire
[Time Frame: Initial 8 weeks and 3mths]
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Borg Score
[Time Frame: Initial, 8 weeks and 3 months]
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Lung function
[Time Frame: Initial, 8 weeks and 3 months]
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Modified Medical Research Council Score
[Time Frame: Initial, 8 weeks and 3 monts]
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Secondary ID(s)
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RCT-2-Acu
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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