|- candidate number||13246|
|- NTR Number||NTR3587|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-aug-2012|
|- Secondary IDs||NL25920.091.08 / 3.4.08.040; CCMO / Astmafonds|
|- Public Title||The effect of pulmonary rehabilitation in COPD: Dynamic hyperinflation and systemic inflammation during daily activities.|
|- Scientific Title||The effect of pulmonary rehabilitation on respiratory impairments, dyspnea and systemic inflammation during daily activities (ADL) in patients with COPD.|
|- hypothesis||It is hypothesized that in patients with COPD pulmonary rehabilitation will reduce respiratory impairments like dynamic hyperinflation and dyspnea during daily activities compared to control patients. Furthermore, rehabilitation will reduce the systemic inflammatory response induced by ADL.|
|- Healt Condition(s) or Problem(s) studied||Chronic Obstructive Pulmonary Disease (COPD)|
|- Inclusion criteria||1. Stable COPD GOLD I-III;|
2. Dynamic hyperinflation during ADL.
|- Exclusion criteria||1. Long term oxygen therapy at home;|
2. Severe ADL-limiting cardiac or neuromuscular disease;
3. Co-existing lung disease other than COPD;
4. Other inflammatory diseases;
5. Treatment with systemic anti-inflammatory drugs;
6. Previous participation in rehabilitation program (<2 year).
Extra exclusion criterium for control COPD patients:
1. Participation in supervised physical therapy program.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-sep-2012|
|- planned closingdate||1-jul-2013|
|- Target number of participants||26|
|- Interventions||The multidisciplinary outpatient pulmonary rehabilitation program consists of a 10-week training program with 2 hour sessions, 3 times a week. The pulmonary rehabilitation program also includes education sessions and psychosocial support or nutritional intervention if necessary.
As a control group, COPD patients from the same hospital will be included. They receive usual COPD care which might include education, nutritional intervention if necessary, but no supervised physical exercise training. |
|- Primary outcome||1. Dynamic hyperinflation;|
3. Biomarkers of systemic inflammation after ADL.
Dynamic hyperinflation and other respiratory impairments during ADL will be measured using the Oxycon Mobile (Viasys Healthcare, Germany), which is a portable breath-by-breath system, consisting of a face mask with turbine volume transducer and integrated O2 and CO2 gas analyzers. Subjects will be asked to rate their shortness of breath using a 10-point Borg scale at start and end of each ADL. Systemic inflammation will be characterized by measuring the number of circulating leukocytes (standard laboratory tests), and plasma levels of interleukins.
|- Secondary outcome||N/A|
|- Timepoints||Before and after rehabilitation or control period:|
1. Before daily activity (rest);
2. Immediately after daily activity.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. L.M. Willems|
|- CONTACT for SCIENTIFIC QUERIES||MSc. L.M. Willems|
|- Sponsor/Initiator ||Radboud University Nijmegen Medical Centre, Department of Pulmonary diseases|
(Source(s) of Monetary or Material Support)
|Radboud University Nijmegen Medical Centre, Department of Pulmonary diseases, Longfonds The Netherlands , Astra Zeneca|
|- Brief summary||This study will focus on the effect of pulmonary rehabilitation on respiratory impairments, dyspnea and systemic inflammation during ADL. 13 patients with COPD enter the 10 week outpatient pulmonary rehabilitation program and 13 patients will receive usual COPD care without rehabilitation. Before and after the rehabilitation or (10 weeks during) control period an ADL test will be performed and respiratory impairments will be measured using a portable breath-by-breath system. In addition, before and after ADL, blood will be collected that will be used for determination of biomarkers of systemic inflammation.|
|- Main changes (audit trail)|
|- RECORD||20-aug-2012 - 22-sep-2012|