Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
18/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anita Simonds

ORCID ID

Contact details

Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom
+44 (0)20 7351 8911
a.simonds@rbh.nthames.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC00893

Study information

Scientific title

Effectiveness of pulmonary rehabilitation in chronic obstructive and restrictive lung disease in elderly patients

Acronym

Study hypothesis

This prospective, randomised controlled study will assess the effects of an outpatient and home-based multidisciplinary rehabilitation programme in patients over 65 years old with chronic obstructive pulmonary disease and restrictive ventilatory disorders, by assessing the impact on physiological outcome measures, quality of life and future healthcare demands.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

1. Outpatient
2. Home-based multidisciplinary rehabilitation programme

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Clearer understanding of the mechanism of action of pulmonary rehabilitation in elderly patients
2. Knowledge of whether the effects differ in obstructive and restrictive disorders
3. A comparison of incomes from a hospital outpatient scheme versus home-based scheme
4. Understanding of the impact of pulmonary rehabilitation on future healthcare demands

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1998

Overall trial end date

01/09/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Outpatients over 65 years of age with COPD and restrictive ventilatory disorders.
2. Forced expiratory volume in one second (FEV1) <50% pred obstructive
3. Forced vital capacity (FVC) <50% pred restrictive

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Uncontrolled cardiac disease
2. Mobility limited by non-respiratory cause

Recruitment start date

01/01/1998

Recruitment end date

01/09/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton Hospital
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/03/2016: No publications found, verifying study status with principal investigator