|- candidate number||16563|
|- NTR Number||NTR4452|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-feb-2014|
|- Secondary IDs||NL46935.068.13 METC 13-3-055|
|- Public Title||ADLs before and after rehabilitation in patients with COPD and CHF|
|- Scientific Title||Activities of daily life (ADLs) before and after rehabilitation in patients with COPD and CHF.|
|- hypothesis||To study the effects of pulmonary rehabilitation on daily physical activity in patients with COPD and CHF. It seems reasonable to hypothesize that an improved sub-maximal performance capacity following pulmonary rehabilitation and the correct use of ECTs will result in a lower task-related metabolic load and reduce the burden of ADLs in patients with COPD and CHF. |
|- Healt Condition(s) or Problem(s) studied||Chronic Obstructive Pulmonary Disease (COPD), Chronic Heartfalure|
|- Inclusion criteria||1. Patients with COPD as a primary diagnosis according to the Global Initiative For Chronic Obstructive Pulmonary Lung Disease (GOLD) definition: ”±Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients. Its pulmonary component is characterized by airflow limitation that is not fully reversible.The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases”±. COPD is diagnosed by a chest physician. Patients with mild (GOLDI; FEV1/FVC<70% and FEV1”Ż80% of predicted value) to very severe (GOLDIV; FEV1/FVC<70% and FEV1<30% of predicted value) COPD will be included in the study. OR
2. Patients with CHF as a primary diagnosis according to the American College of Cardiology and American Heart Association definition: ”°Heart failure is a complex clinical syndrome that can resultfrom any structural or functional cardiac disorder that impairs the ability of the ventricle to fill with or eject blood”±. CHF is diagnosed by a cardiologist. Patients with mild (NYHA class I) to severe (NYHA class IV) will be included in the study.
3. Clinically stable on the basis of clinical picture by chest physician or cardiologist.
4. Treated according to the current international guidelines.
5. Permission for voluntary participation. Patients will be asked after baseline assessment and have to sign an informed consent. |
|- Exclusion criteria||1. Neuromuscular co-morbidities. Patients with neuromuscular co-morbidities can experience problems, not caused by COPD or CHF, during the performance of the activities of daily life.
2. Lack of motivation for voluntary participation in this study.
3. Patients with long-term oxygen therapy use will be excluded for measurements of metabolic load. |
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||1-apr-2014|
|- planned closingdate||1-apr-2015|
|- Target number of participants||80|
|- Interventions||ADL-test before and after rehabilitation|
|- Primary outcome||The difference in ventilation and oxygen uptake during the performance of ADL before and after rehabilitation. |
|- Secondary outcome||1.Difference in physical activity
2.Difference in heart rate
3.Difference in time to accomplish the ADLs 4.Difference in Borg symptom scores after the performance of ADLs
5.Differences in COPM (patients scores on performance and satisfaction) |
|- Timepoints||Patients will be asked to perform 2 ADL-tests before and 1 ADL-test after rehabilitation|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. Martijn A. Spruit|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Martijn A. Spruit|
|- Sponsor/Initiator ||CIRO+ (Centre of expertise for chronic organ failure)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background of the study:
The degree and impact of dyspnea during ADLs in patients with COPD and CHF is worse compared to healthy elderly subjects. Various non-pharmacological interventions, like exercise training and energy conservation techniques, can be considered to reduce the task-related dyspnea sensation and, in turn, improve the performance of ADLs in COPD and CHF. However, its effects have never been studied. Therefore, there is a clear rationale to study the effects on the performance of domestic ADLs in patients with COPD and CHF after a program of high-intensity interval training in combination with occupational therapy.
Objective of the study:
To study the effects of pulmonary rehabilitation on daily physical activity in patients with COPD and CHF. It seems reasonable to hypothesize that an improved sub-maximal performance capacity following pulmonary rehabilitation and the correct use of ECTs will result in a lower task-related metabolic load and reduce the burden of ADLs in patients with COPD and CHF.
Longitudinal observational design.
Patients with clinically stable COPD and CHF entering rehabilitation at Ciro+.
Primary study parameters/outcome of the study:
The difference in ventilation and oxygen uptake during the performance of ADL before and after rehabilitation.
Secundary study parameters/outcome of the study (if applicable):
-Difference in physical activity
-Difference in heart rate
-Difference in time to accomplish the ADLs -Difference in Borg symptom scores after the performance of ADLs
-Differences in COPM (patients scores on performance and satisfaction)
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
All intervention take place at Ciro+ in Horn as part of regular pulmonary rehabilitation. In addition, an extra test (cardiopulmonary exercise test) will be added to the post-rehabilitation assessment Furthermore, patients will perform 3 ADL-tests. The risks of participation in the study are almost zero.
|- Main changes (audit trail)|
|- RECORD||26-feb-2014 - 8-apr-2014|