Evaluating the effects of early pulmonary rehabilitation on exercise capacity, quality of life and readmission.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
exercise tolerance in meters.
Secondary outcome
exacerbations and (re)admissions rate.
quality of life.
Background summary
Hospital admissions because of exacerbation COPD is a burden. Despite optimal
therapy during admission, rthe ecovery time after discharge lasts long. A
previous trial has shown that 25 % of the patients is not recovered at all,
three months after discharge from the hospital, measured in lungfunction.
Recovery of the quality of life is lasting longer, even if an exacerbation does
not occur. Admission because of exacerbation COPD increases the risk of
readmission. Interventions leading to fast recovery and improving symptoms
after a hospital admission, would not decrease only readmissions, but would
increase also quality of life of the COPD patient in daily life. Pulmonary
rehabilitation is a multidisciplinary treatment, whereby medical and
psychosocial interventions including training, education and nutrition are
used. Pulmonary rehabilitation by stable COPD patients is seemed to be regular
care and cost-effective. However, the effect of early pulmonary rehabilitation
by acute exacerbation patients in the recovery period is not investigated
properly. The expectancy is that early rehabilitation after admission because
of exacerbation COPD is safe and will profound statistically and clinically
improvement in exercise capacity, quality of life and a decrease of hospital
readmissions.
Study objective
Evaluating the effects of early pulmonary rehabilitation on exercise capacity,
quality of life and readmission.
Study design
Hundred patients with an acute exacerbation of COPD admitted to the regular
pulmonology department via the emergency room are recruited, after they have
given written informed consent. Inclusion criteria are an age > 40 years or <=
80 years, at least 10 packyears of smoking history and COPD at least GOLD II.
Each form of physical therapy is accepted outside pulmonary rehabilitation.
Exclusion criteria include participation in a pulmonary rehabilitation program
in the preceding year, comorbidity that can limit exercise training (for
example: invalidating ischaemic heart disease, RA, malignancy and lung
embolus), intolerance to prednisolon, history of asthma, non-compliance,
findings on chest radiography other than fitting with signs of COPD and a prior
randomisation. During admission patients are receiving standard exacerbation
COPD treatment consisting of O2, Combivent inhalation, antibiotics and
prednison. Exercise capacity is measured by a 6 minute walk test performed
before randomisation and discharge from the hospital as well as a spirometry.
These measurements will be repeated after discharge from hospital at 3 months.
Quality of life is evaluated by the following questionnaires at discharge: St.
George respiratory questionnaire (SGRQ), SF-36-scores (short form health
survey) and CCQ. Before discharge patients are randomised with a computer
minimisation program for pulmonary rehabilitation or usual care with special
attendance to age (< 70 years or >= 70 years), sex, length of hospital admission
(< 7 days or >= 7 days ), six minute walk test distance at discharge (< 100
meters >= 100 meters ) and predicted forced expiratory volume in one second
(FEV1< or >= FEV1). Pulmonary rehabilitation will take place within ten days
after discharge and shall be given by a multidisciplinary team (pulmonologist,
respiratory nurse, physical therapist, dietician and a social worker). The
program will last 2 hours weekly; 1 hour exercise training and one hour
education during 8 weeks. All patients are followed up after discharge at 3 and
6 months.The questionnaires will be repeated at 3 and 6 months. Readmission
rate will be also evaluated in this period.
Intervention
Participate to early pulmonary rehabilitation during 8 weeks for 2 hours
weekly.
Study burden and risks
Patients have to perform the walk test twice, have to blow a spirometry twice
and have to fill in the three quality of life questionnaires for 3 times during
hospital admission and after discharge. Patients have to participate also to
the weekly 2 hour lasting pulmonary rehabilitation program. Patients will
receive a taxi-pass for these visits. There are no direct adverse effects due
to the rehabilitation program. Patients in the *regular care* group will not be
guided by the multidisciplinary rehabilitation team. Exercise and physical
therapy outside pulmonary rehabilitation is tolerated. The expected benefits
are a better exercise tolerance, less exacerbations, a lower re-admission rate
and a better quality of life. Patients will also be seen more often after
discharge. Two appointments will be made after discharge from the hospital.
Questions will be answered during these visits.
Groot Wezenland 20
8011 J W Zwolle
Nederland
Groot Wezenland 20
8011 J W Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
age between 40 and 80 years
at least COPD GOLD II
at least 10 packyears of smoking history
physical therapy outside pulmonary rehabilitation
Exclusion criteria
pulmonary rehabilitation in previous year
comorbidity limiting rehabilitation
intolerance to prednison
non-compliance
asthma in history
prior randomisation in trial
radiological findings not fitting with COPD
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
CCMO | NL11494.075.06 |