Clinical trial NCT01112943: Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?
Official title: The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Acupuncture, Pulmonary Rehabilitation, Inflammation, COPD
Lead sponsor: Beaumont Hospital
Sponsor class: OTHER
Collaborators: name: University College Dublin
First posted: 2010-04-29
Enrollment: 44
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life score, St George's Quality of Life score
timeFrame: Initial, 8 weeks and 3 months
Secondary outcomes:
measure: 6 minute walk test
timeFrame: Initial, 8 weeks and three months
measure: 'Free Living' Activity Levels
timeFrame: Initial, 8weeks and 3 months
measure: St. George's Respiratory Questionnaire
timeFrame: Initial 8 weeks and 3mths
measure: Incremental Shuttle Walk Test
timeFrame: Initial, 8 weeks and 3 months
measure: Borg Score
timeFrame: Initial, 8 weeks and 3 months
measure: EuroQol 5D
timeFrame: Initial, 8 weeks and 3 months
measure: Lung function
timeFrame: Initial, 8 weeks and 3 months
measure: Inflammatory Markers
timeFrame: Initial, 8 weeks and 3 monts
measure: Modified Medical Research Council Score
timeFrame: Initial, 8 weeks and 3 monts
measure: BODE Index
timeFrame: Initial, 8 weeks and 3 months
Other outcomes:
Locations:
city: Beaumont
country: Ireland
facility: Beaumont Hospital
state: Dublin
Study officials:
affiliation: Beaumont Hospital
name: Richard W Costello, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of College, Dublin
name: Brona Fullen, DR
role: STUDY_CHAIR
References:
citation: Egan C, Deering BM, Blake C, Fullen BM, McCormack NM, Spruit MA, Costello RW. Short term and long term effects of pulmonary rehabilitation on physical activity in COPD. Respir Med. 2012 Dec;106(12):1671-9. doi: 10.1016/j.rmed.2012.08.016. Epub 2012 Oct 12.