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
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