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Completed

NCT Number: NCT01112943

Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beaumont Hospital

Beaumont, Dublin, 5, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

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

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

Pulmonary Rehabilitation

Other

a seven week pulmonary rehabilitation course

Primary outcomes

  1. 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 outcomes

  1. 6 minute walk test

    Time frame: Initial, 8 weeks and three months

    Prognostic indicator that includes a measure of exercise capacity.

  2. 'Free Living' Activity Levels

    Time frame: Initial, 8weeks and 3 months

    SenseWare Activity Monitors which measure total energy expenditure.

  3. St. George's Respiratory Questionnaire

    Time frame: Initial 8 weeks and 3mths

    A valid and reliable disease specific questionnaire

  4. 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.

  5. Borg Score

    Time frame: Initial, 8 weeks and 3 months

    Breathlessness Score

  6. EuroQol 5D

    Time frame: Initial, 8 weeks and 3 months

    A generic quality of life questionnaire with a Utility score.

  7. Lung function

    Time frame: Initial, 8 weeks and 3 months

    Spirometry and PiMax

  8. Inflammatory Markers

    Time frame: Initial, 8 weeks and 3 monts

    IL6, IL8, TNF alpha and CRP

  9. Modified Medical Research Council Score

    Time frame: Initial, 8 weeks and 3 monts

    Subjective activity score based on breathlessness

  10. BODE Index

    Time frame: Initial, 8 weeks and 3 months

    Prognostic indicator for survival

Sponsors and collaborators

Lead sponsor

Beaumont Hospital

Other

Collaborators

  • University College Dublin

Registry information

Official study title

The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Apr 29, 2010
Registry last updated
Aug 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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