Chronic Obstructive Pulmonary DiseaseNCT01112943
Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?
A study testing Acupuncture and Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Beaumont Hospital at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Acupuncture and Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIreland
- Study dates
- Jul 2007to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Fear of needles
- Lung Cancer
- Previous attendance at pulmonary rehabilitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation
The hypothesis of this study was that acupuncture in conjunction with standard care of pulmonary rehabilitation improves outcome measures compared to pulmonary rehabilitation alone.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Acupuncture, Pulmonary Rehabilitation
- Keywords
- Acupuncture, Pulmonary Rehabilitation, Inflammation, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Also called Single use needles.25mm /x 0.22 (VINCO) needles
Acupuncture on predefined points for 20min once a week over seven weeks
Pulmonary RehabilitationOther
a seven week pulmonary rehabilitation course
Pulmonary RehabilitationOther
Twice a week for seven weeks. Each session lasting 2 hrs (1hr exercise and 1hr education
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture on predefined points once a week for 20 minutes over the seven week pulmonary rehabilitation course Receives: Other: Acupuncture; Other: Pulmonary Rehabilitation |
| Pulmonary Rehabilitation | Active comparator | A seven week exercise and educational class run twice a week using international guidelines. Receives: Other: Pulmonary Rehabilitation |
| Control | No intervention | Three assessments over the same time frame of three months but without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Initial, 8 weeks and 3 months
Secondary outcomes (10)
6 minute walk test
Prognostic indicator that includes a measure of exercise capacity.
Measured: Initial, 8 weeks and three months
'Free Living' Activity Levels
SenseWare Activity Monitors which measure total energy expenditure.
Measured: Initial, 8weeks and 3 months
St. George's Respiratory Questionnaire
A valid and reliable disease specific questionnaire
Measured: Initial 8 weeks and 3mths
Incremental Shuttle Walk Test
This is an incremental, submaximal field exercise test that is sensitive to pulmonary rehabilitation intervention.
Measured: Initial, 8 weeks and 3 months
Borg Score
Breathlessness Score
Measured: Initial, 8 weeks and 3 months
EuroQol 5D
A generic quality of life questionnaire with a Utility score.
Measured: Initial, 8 weeks and 3 months
Lung function
Spirometry and PiMax
Measured: Initial, 8 weeks and 3 months
Inflammatory Markers
IL6, IL8, TNF alpha and CRP
Measured: Initial, 8 weeks and 3 monts
Modified Medical Research Council Score
Subjective activity score based on breathlessness
Measured: Initial, 8 weeks and 3 monts
BODE Index
Prognostic indicator for survival
Measured: Initial, 8 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startJul 2007
- Primary completionNov 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin
- Responsible party
- Principal investigator, Professor Richard Costello, Beaumont Hospital
- Investigators
- Richard W Costello, Professor, Principal investigator, Beaumont HospitalBrona Fullen, DR, Study chair, University of College, Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112943
- Sponsor's protocol ID
- RCT-2-Acu
- Status last verified
- Aug 2012
- First submitted
- 26 Apr 2010
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23063203
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT01112943
- Acronym / sponsor ID
- RCT-2-Acu
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Acupuncture, Pulmonary Rehabilitation, Inflammation, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Collaborators
- University College Dublin
- Study start
- Jul 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 29 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: Acupuncture, Other: Pulmonary RehabilitationAcupuncture on predefined points once a week for 20 minutes over the seven week pulmonary rehabilitation course |
| Pulmonary Rehabilitation | Active comparator | Other: Pulmonary RehabilitationA seven week exercise and educational class run twice a week using international guidelines. |
| Control | No intervention | –Three assessments over the same time frame of three months but without intervention |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: Single use needles.25mm /x 0.22 (VINCO) needlesAcupuncture on predefined points for 20min once a week over seven weeks | Other | Acupuncture |
| Pulmonary Rehabilitationa seven week pulmonary rehabilitation course | Other | Acupuncture |
| Pulmonary RehabilitationTwice a week for seven weeks. Each session lasting 2 hrs (1hr exercise and 1hr education | Other | Pulmonary Rehabilitation |
Primary outcome
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.
10 secondary outcomes
6 minute walk test
Time frame: Initial, 8 weeks and three months
'Free Living' Activity Levels
Time frame: Initial, 8weeks and 3 months
St. George's Respiratory Questionnaire
Time frame: Initial 8 weeks and 3mths
Incremental Shuttle Walk Test
Time frame: Initial, 8 weeks and 3 months
Borg Score
Time frame: Initial, 8 weeks and 3 months
EuroQol 5D
Time frame: Initial, 8 weeks and 3 months
Lung function
Time frame: Initial, 8 weeks and 3 months
Inflammatory Markers
Time frame: Initial, 8 weeks and 3 monts
Modified Medical Research Council Score
Time frame: Initial, 8 weeks and 3 monts
BODE Index
Time frame: Initial, 8 weeks and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
- Derived from this study: PubMed 23063203Egan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard W Costello, Professor principal investigator
Beaumont Hospital
Brona Fullen, DR study chair
University of College, Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Beaumont Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score, St George's Quality of Life score (time frame: Initial, 8 weeks and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01112943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2012.