Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01112943
Recruitment Status : Completed
First Posted : April 29, 2010
Last Update Posted : August 14, 2012
University College Dublin
Information provided by (Responsible Party):
Professor Richard Costello, Beaumont Hospital

Brief Summary:
The hypothesis of this study was that acupuncture in conjunction with standard care of pulmonary rehabilitation improves outcome measures compared to pulmonary rehabilitation alone.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Acupuncture Other: Pulmonary Rehabilitation Not Applicable

Detailed Description:
Pulmonary Rehabilitation is recognized as a pivotal component in International Guidelines for the management of chronic obstructive pulmonary disease (COPD). In patients with COPD, clinical research using acupuncture has reported a significant reduction in the use of medications, decrease breathlessness and increased functional capacity. To our knowledge, this is the first time that these two treatments were combined to compare functional, physiological, biological and emotional/QOL outcomes in this cohort of patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Acupuncture
Acupuncture on predefined points once a week for 20 minutes over the seven week pulmonary rehabilitation course
Other: Acupuncture
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 6 minute walk test [ Time Frame: Initial, 8 weeks and three months ]
    Prognostic indicator that includes a measure of exercise capacity.

  2. 'Free Living' Activity Levels [ Time Frame: Initial, 8weeks and 3 months ]
    SenseWare Activity Monitors which measure total energy expenditure.

  3. St. George's Respiratory Questionnaire [ Time Frame: Initial 8 weeks and 3mths ]
    A valid and reliable disease specific questionnaire

  4. 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.

  5. Borg Score [ Time Frame: Initial, 8 weeks and 3 months ]
    Breathlessness Score

  6. EuroQol 5D [ Time Frame: Initial, 8 weeks and 3 months ]
    A generic quality of life questionnaire with a Utility score.

  7. Lung function [ Time Frame: Initial, 8 weeks and 3 months ]
    Spirometry and PiMax

  8. Inflammatory Markers [ Time Frame: Initial, 8 weeks and 3 monts ]
    IL6, IL8, TNF alpha and CRP

  9. Modified Medical Research Council Score [ Time Frame: Initial, 8 weeks and 3 monts ]
    Subjective activity score based on breathlessness

  10. BODE Index [ Time Frame: Initial, 8 weeks and 3 months ]
    Prognostic indicator for survival

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01112943

Beaumont Hospital
Beaumont, Dublin, Ireland, 5
Sponsors and Collaborators
Beaumont Hospital
University College Dublin
Principal Investigator: Richard W Costello, Professor Beaumont Hospital
Study Chair: Brona Fullen, DR University of College, Dublin

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Professor Richard Costello, Respiratory Consultant, Beaumont Hospital Identifier: NCT01112943     History of Changes
Other Study ID Numbers: RCT-2-Acu
First Posted: April 29, 2010    Key Record Dates
Last Update Posted: August 14, 2012
Last Verified: August 2012

Keywords provided by Professor Richard Costello, Beaumont Hospital:
Acupuncture, Pulmonary Rehabilitation, Inflammation, COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases