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Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?

NCT ID: NCT01112943

Last Updated: 2012-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-01-31

Brief Summary

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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

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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

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Chronic Obstructive Pulmonary Disease

Keywords

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Acupuncture, Pulmonary Rehabilitation, Inflammation, COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupuncture

Acupuncture on predefined points once a week for 20 minutes over the seven week pulmonary rehabilitation course

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Acupuncture on predefined points for 20min once a week over seven weeks

Pulmonary Rehabilitation

Intervention Type OTHER

a seven week pulmonary rehabilitation course

Pulmonary Rehabilitation

A seven week exercise and educational class run twice a week using international guidelines.

Group Type ACTIVE_COMPARATOR

Pulmonary Rehabilitation

Intervention Type OTHER

Twice a week for seven weeks. Each session lasting 2 hrs (1hr exercise and 1hr education

Control

Three assessments over the same time frame of three months but without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

Acupuncture on predefined points for 20min once a week over seven weeks

Intervention Type OTHER

Pulmonary Rehabilitation

a seven week pulmonary rehabilitation course

Intervention Type OTHER

Pulmonary Rehabilitation

Twice a week for seven weeks. Each session lasting 2 hrs (1hr exercise and 1hr education

Intervention Type OTHER

Other Intervention Names

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Single use needles.25mm /x 0.22 (VINCO) needles

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College Dublin

OTHER

Sponsor Role collaborator

Beaumont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Professor Richard Costello

Respiratory Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard W Costello, Professor

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital

Brona Fullen, DR

Role: STUDY_CHAIR

University of College, Dublin

Locations

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Beaumont Hospital

Beaumont, Dublin, Ireland

Site Status

Countries

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Ireland

References

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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.

Reference Type DERIVED
PMID: 23063203 (View on PubMed)

Other Identifiers

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RCT-2-Acu

Identifier Type: -

Identifier Source: org_study_id