The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Quality of life score, St George's Quality of Life score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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 Outcomes
- 6 minute walk test(Initial, 8 weeks and three months)
- 'Free Living' Activity Levels(Initial, 8weeks and 3 months)
- St. George's Respiratory Questionnaire(Initial 8 weeks and 3mths)
- Incremental Shuttle Walk Test(Initial, 8 weeks and 3 months)
- Borg Score(Initial, 8 weeks and 3 months)
- EuroQol 5D(Initial, 8 weeks and 3 months)
- Lung function(Initial, 8 weeks and 3 months)
- Inflammatory Markers(Initial, 8 weeks and 3 monts)
- Modified Medical Research Council Score(Initial, 8 weeks and 3 monts)
- BODE Index(Initial, 8 weeks and 3 months)
Investigators
Professor Richard Costello
Respiratory Consultant
Beaumont Hospital