|- candidate number||4529|
|- NTR Number||NTR1536|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-nov-2008|
|- Secondary IDs||P08-43 |
|- Public Title||Pilot study COPE III|
|- Scientific Title||The effects of a reactivation programme for patients with both COPD and heart failure on exercise capacity and quality of life, a pilot study.|
|- ACRONYM||Pilot study COPE III|
|- hypothesis||Patients with a combination of COPD and CHF who receive a small-group community based reactivation programme will have a higher exercise capacity and quality of life after completing the programme compared to before. |
|- Healt Condition(s) or Problem(s) studied||Chronic Obstructive Pulmonary Disease (COPD), Heart failure, Intervention, Reactivation|
|- Inclusion criteria||1. Age between 40 and 75 |
2. A clinical diagnosis of COPD defined by the GOLD-criteria stage 2 and 3
3. A diagnosis of CHF; New York Heart Association (NYHA) class II-III
4. Left ventricular ejection fraction (LVEF) < 40% by echocardiogram, within 2 months before inclusion
5. A history of smoking of a least 10 pack-years
6. Hemodynamically and respiratory stable and on a stable drug regimen with regard to both COPD and CHF for at least four weeks
7. Able to understand, read and write Dutch.
|- Exclusion criteria||1. Serious other diseases with a low survival rate|
2. Other diseases which generate symptoms of dyspnoea and/or decreased exercise capacity
3. Severe psychiatric illness, diagnosed by anamnesis
4. Severe anaemia (Hb<6)
5. Less than 1 year out of pulmonary of cardiac rehabilitation
6. Disorders or progressive diseases, which seriously influence the ability to walk (e.g. amputation, paralysis, claudicatio intermittens)
7. Medication use of inhibin, buflomedil, ginkgo, pentoxifylinne
8. Poorly regulated diabetes mellitus
9. Resting respiratory rate > 30 breaths/min
10. Resting heart rate > 110 beats/min in rest or atrial fibrillation with a ventricular rate > 100/min at rest
11. Sustained ventricular tachycardias not protected by ICD
12. Indication for a revascularisation intervention
13. A pulmonary embolism or a deep venous thrombosis less than a half year back
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-nov-2008|
|- planned closingdate||1-mei-2009|
|- Target number of participants||9|
|- Interventions|| The patients will participate in a 10 weeks community based reactivation programme under supervision of a physiotherapist. The programme contains cycling, walking, lifting and muscle strength training of the m. Quadriceps. Two self-management session under supervision of a nurse practioner will also be part of the intervention. |
|- Primary outcome||The primary outcome measure is exercise capacity, measured with the six minute walking test. |
|- Secondary outcome||Secondary outcome measure is health related quality of life and health status measured with disease specific (CCQ, CRQ, MLHFQ) and generic questionnaires (MRC).|
Also exercise capacity will be measured with the Incremental Shuttle Walk Test.
|- Timepoints||10 weeks training, a measurement before and after the training|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. P.D.L.P.M. Valk, van der|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.D.L.P.M. Valk, van der|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Netherlands Asthma Foundation|
|- Brief summary||Rationale:|
Congestive heart failure (CHF) is an important co-morbidity in patients with chronic obstructive pulmonary disease (COPD). The beneficial effects of community based reactivation programmes on exercise tolerance have already been demonstrated in patients with solely COPD or solely CHF. However, the evidence for treatment of patients with a combination of COPD and CHF is surprisingly slim since patients with co-morbidity are more or less routinely excluded from the majority of studies.
This pilot study will investigate whether patients with both COPD and CHF who participated in a community based reactivation programme have a higher exercise capacity and a better health related quality of life after the programme in comparison with before.
The design of the study is a pilot intervention study with a measurement before and after the study.
Study population: Nine patients, aged between 40 and 75 years, with a combination of COPD (GOLD II-III) and CHF (NHYA II-III) will be included in this study. The patients are at least four weeks hemodynamically and respiratory stable and on a stable drug regimen with regard to both COPD and CHF. Patients will be recruited from the out-patient departments of pulmonology and cardiology of Medisch Spectrum Twente in Enschede.
The patients will participate in a 10 weeks community based reactivation programme under supervision of a physiotherapist. The programme contains cycling, walking, lifting and muscle strength training of the m. Quadriceps. Two self-management session under supervision of a nurse practioner will also be part of the intervention.
Main study parameters/endpoints:
The primary outcome measure is exercise capacity, measured with the six minute walking test. Secondary outcome measure is health related quality of life measured with disease specific and generic questionnaires.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The risk of the study is negligible. Patients will train under supervision of in COPD and heart failure trained physiotherapists. The physiotherapists will stop or modify the training intervention when one of the following symptoms occur:
1) marked shortness of breath or fatigue (Borg scale >13);
2) respiratory rate > 40/minute during exercise;
3) weight gain of more than two kilograms within 2-3 days.
The patients have to come three times to the hospital to undergo physical tests and to fill in questionnaires.
|- Main changes (audit trail)|
|- RECORD||16-nov-2008 - 26-feb-2009|