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Pilot study COPE III

The effects of a reactivation programme for patients with both COPD and heart failure on exercise capacity and quality of life, a pilot study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26380
Enrollment
9
Registered
2008-11-16
Start date
2008-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intervention, COPD, heart failure, reactivation interventie, COPD, hartfalen, reactivatie

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

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Inclusion criteria

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

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 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

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is exercise capacity, measured with the six minute walking test.

Secondary

MeasureTime frame
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.

Contacts

Public ContactP.D.L.P.M. Valk, van der

Medisch Spectrum Twente Hospital Department of Pulmonology PO Box 50.000

P.vanderValk@mst.nl+31 (0)53 4872610

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)