Condition category
Respiratory
Date applied
13/11/2007
Date assigned
07/01/2008
Last edited
07/01/2008
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

Mrs Tanja Effing

ORCID ID

Contact details

Haaksbergerstraat 55
Poli 12
Enschede
7513 ER
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NT1101

Study information

Scientific title

Acronym

PULMOFIT-MST

Study hypothesis

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of disability and mortality worldwide. Morbidity and mortality among COPD-patients are strongly related to acute exacerbations of COPD, which can be defined as sustained worsening of the patient’s condition, from stable state and beyond normal day-to-day variations, that is acute in onset and may warrant additional treatment in a patient with underlying COPD. Severe exacerbations may lead to hospital admissions and have a major impact on disease evolution and costs.

Pulmofit-MST, an immediate reactivation programme, will induce a reduction of the length of stay in the hospital, by preventing loss of peripheral muscle force and exercise capacity and thereby initiating a faster recovery of activities of daily living.

Ethics approval

Ethics approval received from the local medical ethics committee (Medisch Etische Toetsingscommissie Medisch Spectrum Twente) on the 16th January 2006 (ref: P06-05).

Study design

Randomised, active controlled, parallel group, two armed trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic Obstructive Pulmonary Disease (COPD)

Intervention

The protocol of the programme aimed at an active role of COPD-patients during their stay in the hospital. Patients in the intervention group were asked to perform three daily training sessions of 15 minutes each. One daily session was assisted by a physiotherapist, while the other two had to be performed by the patients themselves.

PULMOFIT-MST consists of four levels of increasing difficulty. Within four hours after admission, level I was started by the nurse who distributed the workbook with the description of all exercises and who instructed the first exercises to the patient. Within 24 hours after admission, the physiotherapist visited the patient and continued the programme by choosing the appropriate follow-up level and determining the intensity of the exercises. Every day the physiotherapist evaluated the exercises and the appropriateness of the training level and training intensity. A workbook functioned as a daily diary in which the intensities of training exercises were noted by the physiotherapist and daily experiences and improvements by the patient. All disciplines (chest physicians, nurses, and physiotherapists) stimulated patients to perform all three daily PULMOFIT-MST sessions.

Patients in the control group received usual care, meaning treatment the patients would have received prior to this study.

The duration of the treatment depends on the length of the hospitalisation. Patients of the intervention group are treated according to the PULMOFIT-MST protocol during the whole hospitalisation period.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Length of hospital stay, defined as number of days between day of admission and day of medical discharge. Day of medical discharge was distinguished from the actual day of discharge because some patients remain in hospital longer than medically necessary (e.g. patients could not yet be referred to a nursing home).

Secondary outcome measures

1. Walking distance (3 minutes walking test)
2. Dyspnoea (Borg scale)
3. Health status (Clinical COPD Questionnaire)
4. Activities of daily living (Barthel Index)
5. Readmissions due to a COPD-exacerbation (less than 28 days), measured at 28 days

Measurements take place at the day of admission, day 4 and the day of medical discharge.

Overall trial start date

01/02/2006

Overall trial end date

01/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. A clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
2. A clinical diagnosis of an exacerbation of COPD for which hospitalisation was required
3. (Ex-) smoker
4. Age above 40 years
5. A life expectancy of at least 3 months
6. Able to understand and read Dutch
7. An informed consent from the subject prior to participation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Pneumonia
2. Fever (greater than 38.5°C)
3. Severe confusion
4. Severe heart failure, New York Heart Association (NHYA) class III or IV
5. Relevant co-morbidity seriously influencing mobility

Recruitment start date

01/02/2006

Recruitment end date

01/02/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Haaksbergerstraat 55
Enschede
7513 ER
Netherlands

Sponsor information

Organisation

Dutch Asthma Foundation (The Netherlands)

Sponsor details

Postbus 5
Leusden
3830 AA
Netherlands

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Dutch Asthma Foundation (The Netherlands)

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