Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?

August 12, 2012 updated by: Professor Richard Costello, Beaumont Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Dublin
      • Beaumont, Dublin, Ireland, 5
        • Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
Acupuncture on predefined points once a week for 20 minutes over the seven week pulmonary rehabilitation course
Other: Acupuncture
Acupuncture on predefined points for 20min once a week over seven weeks
Other Names:
  • Single use needles.25mm /x 0.22 (VINCO) needles
Other: Pulmonary Rehabilitation
a seven week pulmonary rehabilitation course
Other: Pulmonary Rehabilitation
Twice a week for seven weeks. Each session lasting 2 hrs (1hr exercise and 1hr education
Active Comparator: Pulmonary Rehabilitation
A seven week exercise and educational class run twice a week using international guidelines.
Other: Pulmonary Rehabilitation
a seven week pulmonary rehabilitation course
Other: Pulmonary Rehabilitation
Twice a week for seven weeks. Each session lasting 2 hrs (1hr exercise and 1hr education
No Intervention: Control
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
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.
Initial, 8 weeks and 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beaumont Hospital

Collaborators

University College Dublin

Investigators

  • Principal Investigator: Richard W Costello, Professor, Beaumont Hospital
  • Study Chair: Brona Fullen, DR, University of College, Dublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

April 26, 2010

First Submitted That Met QC Criteria

April 28, 2010

First Posted (Estimate)

April 29, 2010

Study Record Updates

Last Update Posted (Estimate)

August 14, 2012

Last Update Submitted That Met QC Criteria

August 12, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT-2-Acu

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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