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 patients 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
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