Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Other: AcupunctureOther: Pulmonary Rehabilitation
- Registration Number
- NCT01112943
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acupuncture Acupuncture Acupuncture on predefined points once a week for 20 minutes over the seven week pulmonary rehabilitation course Acupuncture Pulmonary Rehabilitation Acupuncture on predefined points once a week for 20 minutes over the seven week pulmonary rehabilitation course Pulmonary Rehabilitation Pulmonary Rehabilitation A seven week exercise and educational class run twice a week using international guidelines.
- Primary Outcome Measures
Name Time Method Quality of life score, St George's Quality of Life score 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
Name Time Method 6 minute walk test Initial, 8 weeks and three months Prognostic indicator that includes a measure of exercise capacity.
'Free Living' Activity Levels Initial, 8weeks and 3 months SenseWare Activity Monitors which measure total energy expenditure.
St. George's Respiratory Questionnaire Initial 8 weeks and 3mths A valid and reliable disease specific questionnaire
Incremental Shuttle Walk Test Initial, 8 weeks and 3 months This is an incremental, submaximal field exercise test that is sensitive to pulmonary rehabilitation intervention.
Borg Score Initial, 8 weeks and 3 months Breathlessness Score
EuroQol 5D Initial, 8 weeks and 3 months A generic quality of life questionnaire with a Utility score.
Lung function Initial, 8 weeks and 3 months Spirometry and PiMax
Inflammatory Markers Initial, 8 weeks and 3 monts IL6, IL8, TNF alpha and CRP
Modified Medical Research Council Score Initial, 8 weeks and 3 monts Subjective activity score based on breathlessness
BODE Index Initial, 8 weeks and 3 months Prognostic indicator for survival
Trial Locations
- Locations (1)
Beaumont Hospital
🇮🇪Beaumont, Dublin, Ireland