NCT01112943

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2010

Completed
Last Updated

August 14, 2012

Status Verified

August 1, 2012

Enrollment Period

1.3 years

First QC Date

April 26, 2010

Last Update Submit

August 12, 2012

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Acupuncture, Pulmonary Rehabilitation, Inflammation, COPD

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (10)

  • 6 minute walk test

    Initial, 8 weeks and three months

  • 'Free Living' Activity Levels

    Initial, 8weeks and 3 months

  • St. George's Respiratory Questionnaire

    Initial 8 weeks and 3mths

  • Incremental Shuttle Walk Test

    Initial, 8 weeks and 3 months

  • Borg Score

    Initial, 8 weeks and 3 months

  • +5 more secondary outcomes

Study Arms (3)

Acupuncture

EXPERIMENTAL

Acupuncture on predefined points once a week for 20 minutes over the seven week pulmonary rehabilitation course

Other: AcupunctureOther: Pulmonary Rehabilitation

Pulmonary Rehabilitation

ACTIVE COMPARATOR

A seven week exercise and educational class run twice a week using international guidelines.

Other: Pulmonary Rehabilitation

Control

NO INTERVENTION

Three assessments over the same time frame of three months but without intervention

Interventions

AcupunctureOTHER

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

Also known as: Single use needles.25mm /x 0.22 (VINCO) needles
Acupuncture
Pulmonary RehabilitationOTHER

a seven week pulmonary rehabilitation course

Acupuncture

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Hospital

Beaumont, Dublin, 5, Ireland

Location

Related Publications (1)

  • Egan C, Deering BM, Blake C, Fullen BM, McCormack NM, Spruit MA, Costello RW. Short term and long term effects of pulmonary rehabilitation on physical activity in COPD. Respir Med. 2012 Dec;106(12):1671-9. doi: 10.1016/j.rmed.2012.08.016. Epub 2012 Oct 12.

    PMID: 23063203DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveInflammation

Interventions

Acupuncture TherapyNeedles

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsEquipment and Supplies

Study Officials

  • Richard W Costello, Professor

    Beaumont Hospital

    PRINCIPAL INVESTIGATOR

  • Brona Fullen, DR

    University of College, Dublin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Respiratory Consultant

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 29, 2010

Study Start

July 1, 2007

Primary Completion

November 1, 2008

Study Completion

January 1, 2009

Last Updated

August 14, 2012

Record last verified: 2012-08

Locations

IE(1)