Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?

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.

Official Title
-----------------
The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Acupuncture
* Other: Pulmonary Rehabilitation
* Other: Pulmonary Rehabilitation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Acupuncture on predefined points once a week for 20 minutes over the seven week pulmonary rehabilitation course | Other: Acupuncture<br>* Acupuncture on predefined points for 20min once a week over seven weeks<br>* Other names: Single use needles.25mm /x 0.22 (VINCO) needles;Other: Pulmonary Rehabilitation<br>* a seven week pulmonary rehabilitation course<br>|
| Active Comparator: Pulmonary Rehabilitation<br>A seven week exercise and educational class run twice a week using international guidelines. | Other: Pulmonary Rehabilitation<br>* Twice a week for seven weeks. Each session lasting 2 hrs (1hr exercise and 1hr education<br>|
| No Intervention: Control<br>Three assessments over the same time frame of three months but without intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score, St George's Quality of Life score | 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. | Initial, 8 weeks and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test | Prognostic indicator that includes a measure of exercise capacity. | Initial, 8 weeks and three months | 
| 'Free Living' Activity Levels | SenseWare Activity Monitors which measure total energy expenditure. | Initial, 8weeks and 3 months | 
| St. George's Respiratory Questionnaire | A valid and reliable disease specific questionnaire | Initial 8 weeks and 3mths | 
| Incremental Shuttle Walk Test | This is an incremental, submaximal field exercise test that is sensitive to pulmonary rehabilitation intervention. | Initial, 8 weeks and 3 months | 
| Borg Score | Breathlessness Score | Initial, 8 weeks and 3 months | 
| EuroQol 5D | A generic quality of life questionnaire with a Utility score. | Initial, 8 weeks and 3 months | 
| Lung function | Spirometry and PiMax | Initial, 8 weeks and 3 months | 
| Inflammatory Markers | IL6, IL8, TNF alpha and CRP | Initial, 8 weeks and 3 monts | 
| Modified Medical Research Council Score | Subjective activity score based on breathlessness | Initial, 8 weeks and 3 monts | 
| BODE Index | Prognostic indicator for survival | Initial, 8 weeks and 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture, Pulmonary Rehabilitation, Inflammation, COPD