Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?
|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) needlesOther: 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
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|