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.
ID
Bron
Verkorte titel
Aandoening
Chronic Obstructive Pulmonary Disease (COPD), exercise, Chronisch Obstructieve Longaandoening, trainingsprogramma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Objectives:
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 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.
Primary outcome:
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.
Doel van het onderzoek
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.
Onderzoeksopzet
T=0 (baseline)
T=1 (4 months post-baseline)
T=2 (7 months post-baseline)
Onderzoeksproduct en/of interventie
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.
Publiek
CAPHRI<br> Research Institute, Department of General Practice<br> P.O. Box 616
Annemieke Fastenau
Maastricht 6200 MD
The Netherlands
+31 (0)43 3882836
annemieke.fastenau@hag.unimaas.nl
Wetenschappelijk
CAPHRI<br> Research Institute, Department of General Practice<br> P.O. Box 616
Annemieke Fastenau
Maastricht 6200 MD
The Netherlands
+31 (0)43 3882836
annemieke.fastenau@hag.unimaas.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL1411 |
NTR-old | NTR1471 |
Ander register | MEC : 08-3-065 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |