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Trial record 4 of 279 for:    pulmonary rehabilitation
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Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?

This study has been completed.
Sponsor:
Collaborator:
University College Dublin
Information provided by (Responsible Party):
Professor Richard Costello, Beaumont Hospital
ClinicalTrials.gov Identifier:
NCT01112943
First received: April 26, 2010
Last updated: August 12, 2012
Last verified: August 2012
History of Changes
  Purpose

The hypothesis of this study was that acupuncture in conjunction with standard care of pulmonary rehabilitation improves outcome measures compared to pulmonary rehabilitation alone.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Other: Acupuncture
Other: Pulmonary Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beaumont Hospital:

Primary Outcome Measures:
  • Quality of life score, St George's Quality of Life score [ Time Frame: Initial, 8 weeks and 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Initial, 8 weeks and three months ] [ Designated as safety issue: No ]
    Prognostic indicator that includes a measure of exercise capacity.

  • 'Free Living' Activity Levels [ Time Frame: Initial, 8weeks and 3 months ] [ Designated as safety issue: No ]
    SenseWare Activity Monitors which measure total energy expenditure.

  • St. George's Respiratory Questionnaire [ Time Frame: Initial 8 weeks and 3mths ] [ Designated as safety issue: No ]
    A valid and reliable disease specific questionnaire

  • Incremental Shuttle Walk Test [ Time Frame: Initial, 8 weeks and 3 months ] [ Designated as safety issue: No ]
    This is an incremental, submaximal field exercise test that is sensitive to pulmonary rehabilitation intervention.

  • Borg Score [ Time Frame: Initial, 8 weeks and 3 months ] [ Designated as safety issue: No ]
    Breathlessness Score

  • EuroQol 5D [ Time Frame: Initial, 8 weeks and 3 months ] [ Designated as safety issue: No ]
    A generic quality of life questionnaire with a Utility score.

  • Lung function [ Time Frame: Initial, 8 weeks and 3 months ] [ Designated as safety issue: No ]
    Spirometry and PiMax

  • Inflammatory Markers [ Time Frame: Initial, 8 weeks and 3 monts ] [ Designated as safety issue: No ]
    IL6, IL8, TNF alpha and CRP

  • Modified Medical Research Council Score [ Time Frame: Initial, 8 weeks and 3 monts ] [ Designated as safety issue: No ]
    Subjective activity score based on breathlessness

  • BODE Index [ Time Frame: Initial, 8 weeks and 3 months ] [ Designated as safety issue: No ]
    Prognostic indicator for survival


Enrollment: 44
Study Start Date: July 2007
Study Completion Date: January 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Single use needles.25mm /x 0.22 (VINCO) needles
Other: Pulmonary Rehabilitation
a seven week pulmonary rehabilitation course
Active Comparator: Pulmonary Rehabilitation
A seven week exercise and educational class run twice a week using international guidelines.
 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

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112943

Locations
Ireland
Beaumont Hospital
Beaumont, Dublin, Ireland, 5
Sponsors and Collaborators
Beaumont Hospital
University College Dublin
Investigators
Principal Investigator: Richard W Costello, Professor Beaumont Hospital
Study Chair: Brona Fullen, DR University of College, Dublin
  More Information

No publications provided

Responsible Party: Professor Richard Costello, Respiratory Consultant, Beaumont Hospital
ClinicalTrials.gov Identifier: NCT01112943     History of Changes
Other Study ID Numbers: RCT-2-Acu
Study First Received: April 26, 2010
Last Updated: August 12, 2012
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by Beaumont Hospital:
Acupuncture, Pulmonary Rehabilitation, Inflammation, COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013