NCT00557115

Brief Summary

The principal aim of the study is to evaluate whether attendance at an exercise training and education programme (known as pulmonary rehabilitation) shortly following hospital discharge can lead to a reduction in exacerbations and improvement in exercise capacity and quality of life in patients with chronic obstructive pulmonary disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

3 active sites

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

January 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2008

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2008

Completed
Last Updated

December 24, 2020

Status Verified

November 1, 2007

Enrollment Period

2.3 years

First QC Date

November 9, 2007

Last Update Submit

December 22, 2020

Conditions

COPD

Keywords

Quality of lifeQuadricepsMuscleExacerbation

Outcome Measures

Primary Outcomes (1)

  • Non-outpatient COPD related hospital attendance (A+E attendance, inpatient admission or death)

    3-months

Secondary Outcomes (5)

  • Disease specific quality of life (CRDQ and SGRQ)

    3 months and 1-year

  • Maximal walking capacity (ISW)and endurance walking capacity (ESW)

    3-months and 1-year

  • Weight and fat free mass (electrical bioimpedance)

    3-months and 1-year

  • Quadriceps muscle strength (volitional and non-volitional)

    3-months and 1-year

  • Cost-effectiveness (Index derived from EQ-5D)

    3-months and 1-year

Study Arms (2)

Usual Care

NO INTERVENTION

Usual Care (UC): usual follow up care post acute COPD exacerbation

EPR

EXPERIMENTAL

Early pulmonary rehabilitation (EPR): pulmonary rehabilitation commenced within 1-week of hospital discharge from an acute COPD exacerbation

Other: Early pulmonary rehabilitation (EPR)

Interventions

Early pulmonary rehabilitation (EPR)OTHER

Multidisciplinary exercise programme in the format of standard pulmonary rehabilitation. Consists of 2 supervised exercise and educations sessions per week for up to 16 sessions within 3-months. Participants are encouraged to keep an exercise diary at perform at least one exercise session at home unsupervised.

EPR

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted to King's College Hospital with a clinical diagnosis of acute exacerbation of COPD. Patients with radiological and microbiological evidence of pneumonia with co-existing COPD will also be included.

You may not qualify if:

  • Significant co-morbidity that could limit exercise training \& testing: Patients unable to walk due to a comorbid neuromuscular or rheumatological condition; patients with severe sensory and cognitive impairment; patients with unstable angina or aortic valve disease in which exercise could be dangerous.
  • Attendance at a pulmonary rehabilitation programme in the preceding year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Basildon University Hospital

Basildon, Essex, United Kingdom

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

King's College Hospital

London, SE5 9RJ, United Kingdom

Location

Related Publications (1)

  • Seymour JM, Moore L, Jolley CJ, Ward K, Creasey J, Steier JS, Yung B, Man WD, Hart N, Polkey MI, Moxham J. Outpatient pulmonary rehabilitation following acute exacerbations of COPD. Thorax. 2010 May;65(5):423-8. doi: 10.1136/thx.2009.124164.

    PMID: 20435864DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • John Moxham, MD FRCP

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2007

First Posted

November 12, 2007

Study Start

January 1, 2006

Primary Completion

April 15, 2008

Study Completion

April 16, 2008

Last Updated

December 24, 2020

Record last verified: 2007-11

Locations

GB(3)