|- candidate number||4160|
|- NTR Number||NTR1471|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-okt-2008|
|- Secondary IDs||08-3-065 MEC |
|- Public Title||Physical Exercise Training Programme COPD in primary care|
|- Scientific Title||Physical Exercise Training Programme COPD in primary care|
|- hypothesis||A physical exercise training programme in patients with mild to moderate COPD is more effective in comparison with usual care (i.e. advice given by the general practitioner) in a primary care setting.|
|- Healt Condition(s) or Problem(s) studied||Chronic Obstructive Pulmonary Disease (COPD), Exercises, Physical exercise|
|- Inclusion criteria||1. COPD patients visiting their general practitioner because of dyspnoea, impaired exercise capacity and/or a reduced quality of life; |
2. Bronchus obstruction detected by spirometry: FEV1/FVC-ratio < 70% and postbronchodilatory FEV1 > 50% predicted (= mild or moderate COPD / GOLD I or II);
3. MRC-score 2 or more;
4. Not meeting the level of exercise performance as defined by the Dutch Standard of Healthy Physical Exercise;
5. Competent enough in speaking the Dutch language.
|- Exclusion criteria||1. Patients who already receive or have received a physical exercise training programme or rehabilitation therapy in the past year; |
2. Patients who have had respiratory tract infections within the last 8 weeks;
3. Presence of serious co-morbid conditions which would interfere with regular exercise training (severe orthopaedic, muscular, or neurological disorders and cardiovascular conditions liable to be aggravated by exercise).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2008|
|- planned closingdate||30-jun-2010|
|- Target number of participants||102|
|- Interventions||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 control group will receive "care as usual", i.e. they will receive advice to improve the physical condition according to the national guidelines of the Dutch College of General Practitioners (NHG). In both groups there will be measurements at baseline, at 4 months and at 7 months.
|- Primary outcome||Primary outcome measure will be the functional exercise capacity measured by the increase in six Minute Walking Distance (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)
- specific health related quality of life (assessed by questionnaires)
- 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.
|- Timepoints||T=0 (baseline)|
T=1 (4 months post-baseline)
T=2 (7 months post-baseline)
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. Annemieke Fastenau|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Jean Muris|
|- Sponsor/Initiator ||University Maastricht (UM), CAPHRI Research Institute|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background: |
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.
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.
In this RCT 102 patients will be analysed. The intervention group will participate in a 4-month physical exercise training programme. The control group will receive verbal and written advice to improve physical condition.
Measurements will take place at baseline, after 4 monhs and after 7 months.
Functional exercise capacity measured by the increase in 6 MWD. Secondary outcome: peripheral muscle strength, physical activity, specific health related quality of life and global perceived effect of the treatment.
|- Main changes (audit trail)|
|- RECORD||1-okt-2008 - 6-dec-2008|