Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?
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|ClinicalTrials.gov Identifier: NCT01112943|
Recruitment Status : Completed
First Posted : April 29, 2010
Last Update Posted : August 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Other: Acupuncture Other: Pulmonary Rehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||January 2009|
Acupuncture on predefined points once a week for 20 minutes over the seven week pulmonary rehabilitation course
Acupuncture on predefined points for 20min once a week over seven weeks
Other Name: Single use needles.25mm /x 0.22 (VINCO) needles
Other: Pulmonary Rehabilitation
a seven week pulmonary rehabilitation course
Active Comparator: Pulmonary Rehabilitation
A seven week exercise and educational class run twice a week using international guidelines.
Other: Pulmonary Rehabilitation
Twice a week for seven weeks. Each session lasting 2 hrs (1hr exercise and 1hr education
No Intervention: Control
Three assessments over the same time frame of three months but without intervention
- Quality of life score, St George's Quality of Life score [ Time Frame: Initial, 8 weeks and 3 months ]A validated assessment of quality of life for patients with COPD. A comparison will be made between those who underwent no rehabilitation the control group and the group who underwent rehabilitation.
- 6 minute walk test [ Time Frame: Initial, 8 weeks and three months ]Prognostic indicator that includes a measure of exercise capacity.
- 'Free Living' Activity Levels [ Time Frame: Initial, 8weeks and 3 months ]SenseWare Activity Monitors which measure total energy expenditure.
- St. George's Respiratory Questionnaire [ Time Frame: Initial 8 weeks and 3mths ]A valid and reliable disease specific questionnaire
- Incremental Shuttle Walk Test [ Time Frame: Initial, 8 weeks and 3 months ]This is an incremental, submaximal field exercise test that is sensitive to pulmonary rehabilitation intervention.
- Borg Score [ Time Frame: Initial, 8 weeks and 3 months ]Breathlessness Score
- EuroQol 5D [ Time Frame: Initial, 8 weeks and 3 months ]A generic quality of life questionnaire with a Utility score.
- Lung function [ Time Frame: Initial, 8 weeks and 3 months ]Spirometry and PiMax
- Inflammatory Markers [ Time Frame: Initial, 8 weeks and 3 monts ]IL6, IL8, TNF alpha and CRP
- Modified Medical Research Council Score [ Time Frame: Initial, 8 weeks and 3 monts ]Subjective activity score based on breathlessness
- BODE Index [ Time Frame: Initial, 8 weeks and 3 months ]Prognostic indicator for survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112943
|Beaumont, Dublin, Ireland, 5|
|Principal Investigator:||Richard W Costello, Professor||Beaumont Hospital|
|Study Chair:||Brona Fullen, DR||University of College, Dublin|