1) To assess the effectiveness of a physical exercise training programme in patients with mild to moderate COPD in the primary care setting, in comparison with usual care. 2) To analyse the main physiological (and behavioural) characteristics of…
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure will be the functional exercise capacity measured by
the increase in 6MWD at 4 months compared to baseline.
Secondary outcome
Secondary outcome measures will be peripheral muscle strength (measured with a
handheld dynamometer), physical activity (assessed by a
pedometer/accelerometer), specific health related quality of life (assessed by
questionnaires) and global perceived effect of the treatment according to the
patients (measured on a GPE scale).
There will also be some exploratory outcome measures, for example lung
function, general health status, motivation and some safety and feasibility
parameters.
Background summary
Physical activity is important for patients with COPD, for the short term as
well as for the long term. For patients with severe and very severe COPD it is
known that pulmonary rehabilitation has a positive effect on dyspnoea, exercise
capacity and quality of life. The effects of a physical exercise training
programme in a primary care setting for patients with mild to moderate COPD are
unknown. It is suggested that there will be considerable gains if these
patients can counteract the systemic consequences of the disease in an early
stage. There will be positive impacts for the patients and presumably less
health care utilization.
Study objective
1) To assess the effectiveness of a physical exercise training programme in
patients with mild to moderate COPD in the primary care setting, in comparison
with usual care.
2) To analyse the main physiological (and behavioural) characteristics of
patients with mild to moderate COPD that determine success of the treatment.
Study design
In this RCT, general practitioners, practice nurses and physiotherapists will
be the main caregivers. The general practice will be the entrance to the trial
and the measurements and the physical exercise training programme will be
performed in the physiotherapy practice.
Intervention
The intervention group will participate in a 4-month physical exercise training
programme in a physiotherapy setting. This programme consists of a combination
of endurance/interval training, resistance training, training of specific
skills and breathing exercises. There will be 2 supervised and 1 unsupervised
training sessions per week. The usual care group will receive advice to improve
the physical condition according to the national guidelines of the Dutch
College of General Practitioners (NHG) and will participate in a low-intensity
cardiovascular training programme. There will be 1 supervised training session
per week. In both groups there will be measurements at baseline, at the end of
the training programme and at 6 + 12 months.
Study burden and risks
The main burden for participants is time-investment. Both groups will undergo 4
consults for the measurements (physical tests and questionnaires). Patients in
both groups will have to participate in a training programme for 4 months at
the physiotherapy practice.
The risks are small. Participants will have to execute a maximal bicycle
ergometry, according to the opinion of the caregivers, in order to investigate
the safety of exercise.
Participation may lead to an improvement in exercise capacity and/or quality of
life in patients with mild to moderate COPD.
Postbus 616
6200 MD Maastricht
Nederland
Postbus 616
6200 MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
COPD patients visiting their general practitioner because of dyspnoea, impaired exercise capacity and/or a reduced quality of life. COPD patients who have a clinical diagnosis of mild to moderate COPD (supported by FEV1/FVC ratio < 0,7 and FEV1 > 50% of predicted post-bronchodilator) and MRC-score >= 2. And not meeting the level of exercise performance as defined by the Dutch Standard of Healthy Physical Exercise.
Exclusion criteria
Patients who already receive or have received a physical exercise training programme or rehabilitation therapy in the past year. Patients who have had respiratory tract infections within the last 8 weeks. Presence of serious co morbid conditions which would interfere with regular exercise training
- severe orthopaedic, muscular, or neurological disorders
- cardiovascular conditions liable to be aggravated by exercise
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 4160 |
| CCMO | NL24510.068.08 |