Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?

Overview

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

Full Title of Study: “The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 2008

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Acupuncture
    • Acupuncture on predefined points once a week for 20 minutes over the seven week pulmonary rehabilitation course
  • Active Comparator: Pulmonary Rehabilitation
    • A seven week exercise and educational class run twice a week using international guidelines.
  • No Intervention: Control
    • Three assessments over the same time frame of three months but without intervention

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 6 minute walk test
    • Time Frame: Initial, 8 weeks and three months
    • Prognostic indicator that includes a measure of exercise capacity.
  • ‘Free Living’ Activity Levels
    • Time Frame: Initial, 8weeks and 3 months
    • SenseWare Activity Monitors which measure total energy expenditure.
  • St. George’s Respiratory Questionnaire
    • Time Frame: Initial 8 weeks and 3mths
    • A valid and reliable disease specific questionnaire
  • 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.
  • Borg Score
    • Time Frame: Initial, 8 weeks and 3 months
    • Breathlessness Score
  • EuroQol 5D
    • Time Frame: Initial, 8 weeks and 3 months
    • A generic quality of life questionnaire with a Utility score.
  • Lung function
    • Time Frame: Initial, 8 weeks and 3 months
    • Spirometry and PiMax
  • Inflammatory Markers
    • Time Frame: Initial, 8 weeks and 3 monts
    • IL6, IL8, TNF alpha and CRP
  • Modified Medical Research Council Score
    • Time Frame: Initial, 8 weeks and 3 monts
    • Subjective activity score based on breathlessness
  • BODE Index
    • Time Frame: Initial, 8 weeks and 3 months
    • Prognostic indicator for survival

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beaumont Hospital
  • Collaborator
    • University College Dublin
  • Provider of Information About this Clinical Study
    • Principal Investigator: Professor Richard Costello, Respiratory Consultant – Beaumont Hospital
  • Overall Official(s)
    • Richard W Costello, Professor, Principal Investigator, Beaumont Hospital
    • Brona Fullen, DR, Study Chair, University of College, Dublin

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