Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112943
• Other study ID #: RCT-2-Acu
• Status: Completed
• Phase: N/A
• First received: April 26, 2010
• Last updated: August 12, 2012
• Start date: July 2007
• Est. completion date: January 2009

Study information

• Verified date: August 2012
• Source: Beaumont Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Acupuncture
Acupuncture on predefined points for 20min once a week over seven weeks
• Pulmonary Rehabilitation
a seven week pulmonary rehabilitation course
• Pulmonary Rehabilitation
Twice a week for seven weeks. Each session lasting 2 hrs (1hr exercise and 1hr education

Locations

Country	Name	City	State
Ireland	Beaumont Hospital	Beaumont	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
Beaumont Hospital	University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life score, St George's Quality of Life score	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	No
Secondary	6 minute walk test	Prognostic indicator that includes a measure of exercise capacity.	Initial, 8 weeks and three months	No
Secondary	'Free Living' Activity Levels	SenseWare Activity Monitors which measure total energy expenditure.	Initial, 8weeks and 3 months	No
Secondary	St. George's Respiratory Questionnaire	A valid and reliable disease specific questionnaire	Initial 8 weeks and 3mths	No
Secondary	Incremental Shuttle Walk Test	This is an incremental, submaximal field exercise test that is sensitive to pulmonary rehabilitation intervention.	Initial, 8 weeks and 3 months	No
Secondary	Borg Score	Breathlessness Score	Initial, 8 weeks and 3 months	No
Secondary	EuroQol 5D	A generic quality of life questionnaire with a Utility score.	Initial, 8 weeks and 3 months	No
Secondary	Lung function	Spirometry and PiMax	Initial, 8 weeks and 3 months	No
Secondary	Inflammatory Markers	IL6, IL8, TNF alpha and CRP	Initial, 8 weeks and 3 monts	No
Secondary	Modified Medical Research Council Score	Subjective activity score based on breathlessness	Initial, 8 weeks and 3 monts	No
Secondary	BODE Index	Prognostic indicator for survival	Initial, 8 weeks and 3 months	No