Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Acupuncture, Pulmonary Rehabilitation, Inflammation, COPD
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.
Interventions
OTHERAcupuncture
Acupuncture on predefined points for 20min once a week over seven weeks
OTHERPulmonary Rehabilitation
a seven week pulmonary rehabilitation course
Sponsors
University College Dublin
Beaumont Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| '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 |
| 6 minute walk test | Initial, 8 weeks and three months | Prognostic indicator that includes a measure of exercise capacity. |
| 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 |
| EuroQol 5D | Initial, 8 weeks and 3 months | A generic quality of life questionnaire with a Utility score. |
Countries
Ireland
Outcome results
None listed