Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Acupuncture
Pulmonary Rehabilitation
Pulmonary Rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Acupuncture, Pulmonary Rehabilitation, Inflammation, COPD
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
Sites / Locations
- Beaumont Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Acupuncture
Pulmonary Rehabilitation
Control
Arm Description
Acupuncture on predefined points once a week for 20 minutes over the seven week pulmonary rehabilitation course
A seven week exercise and educational class run twice a week using international guidelines.
Three assessments over the same time frame of three months but without intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
6 minute walk test
Prognostic indicator that includes a measure of exercise capacity.
'Free Living' Activity Levels
SenseWare Activity Monitors which measure total energy expenditure.
St. George's Respiratory Questionnaire
A valid and reliable disease specific questionnaire
Incremental Shuttle Walk Test
This is an incremental, submaximal field exercise test that is sensitive to pulmonary rehabilitation intervention.
Borg Score
Breathlessness Score
EuroQol 5D
A generic quality of life questionnaire with a Utility score.
Lung function
Spirometry and PiMax
Inflammatory Markers
IL6, IL8, TNF alpha and CRP
Modified Medical Research Council Score
Subjective activity score based on breathlessness
BODE Index
Prognostic indicator for survival
Full Information
NCT ID
NCT01112943
First Posted
April 26, 2010
Last Updated
August 12, 2012
Sponsor
Beaumont Hospital
Collaborators
University College Dublin
1. Study Identification
Unique Protocol Identification Number
NCT01112943
Brief Title
Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?
Official Title
The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beaumont Hospital
Collaborators
University College Dublin
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Acupuncture, Pulmonary Rehabilitation, Inflammation, COPD
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Acupuncture on predefined points once a week for 20 minutes over the seven week pulmonary rehabilitation course
Arm Title
Pulmonary Rehabilitation
Arm Type
Active Comparator
Arm Description
A seven week exercise and educational class run twice a week using international guidelines.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Three assessments over the same time frame of three months but without intervention
Intervention Type
Other
Intervention Name(s)
Acupuncture
Other Intervention Name(s)
Single use needles.25mm /x 0.22 (VINCO) needles
Intervention Description
Acupuncture on predefined points for 20min once a week over seven weeks
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
a seven week pulmonary rehabilitation course
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
Twice a week for seven weeks. Each session lasting 2 hrs (1hr exercise and 1hr education
Primary Outcome Measure Information:
Title
Quality of life score, St George's Quality of Life score
Description
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.
Time Frame
Initial, 8 weeks and 3 months
Secondary Outcome Measure Information:
Title
6 minute walk test
Description
Prognostic indicator that includes a measure of exercise capacity.
Time Frame
Initial, 8 weeks and three months
Title
'Free Living' Activity Levels
Description
SenseWare Activity Monitors which measure total energy expenditure.
Time Frame
Initial, 8weeks and 3 months
Title
St. George's Respiratory Questionnaire
Description
A valid and reliable disease specific questionnaire
Time Frame
Initial 8 weeks and 3mths
Title
Incremental Shuttle Walk Test
Description
This is an incremental, submaximal field exercise test that is sensitive to pulmonary rehabilitation intervention.
Time Frame
Initial, 8 weeks and 3 months
Title
Borg Score
Description
Breathlessness Score
Time Frame
Initial, 8 weeks and 3 months
Title
EuroQol 5D
Description
A generic quality of life questionnaire with a Utility score.
Time Frame
Initial, 8 weeks and 3 months
Title
Lung function
Description
Spirometry and PiMax
Time Frame
Initial, 8 weeks and 3 months
Title
Inflammatory Markers
Description
IL6, IL8, TNF alpha and CRP
Time Frame
Initial, 8 weeks and 3 monts
Title
Modified Medical Research Council Score
Description
Subjective activity score based on breathlessness
Time Frame
Initial, 8 weeks and 3 monts
Title
BODE Index
Description
Prognostic indicator for survival
Time Frame
Initial, 8 weeks and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard W Costello, Professor
Organizational Affiliation
Beaumont Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brona Fullen, DR
Organizational Affiliation
University of College, Dublin
Official's Role
Study Chair
Facility Information:
Facility Name
Beaumont Hospital
City
Beaumont
State/Province
Dublin
ZIP/Postal Code
5
Country
Ireland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23063203
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.
Results Reference
derived
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Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?
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