|- candidate number||14605|
|- NTR Number||NTR3936|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-mrt-2013|
|- Secondary IDs||NL44318.044.13 CCMO|
|- Public Title||Mozart.|
|- Scientific Title||Dynamic hyperinflation (DH) during metronome-paced tachypnea (MPT) and the correlation with the activity status in COPD.|
The rate of DH induced by MPT correlates with the activity status determined with an accelerometer.
1. The rate of recovery after having induced DH by MPT correlates with the activity status determined with an accelerometer;
2. The degree of DH induced by MPT correlates with the activity status determined with an accelerometer.
|- Healt Condition(s) or Problem(s) studied||Chronic Obstructive Pulmonary Disease (COPD)|
|- Inclusion criteria||1. Mild-severe stable COPD;|
2. Ability to read and speak Dutch;
3. Informed consent;
4. An age of atleast 40 years old and not older than 80.
|- Exclusion criteria||1. GOLD stage IV;|
2. COPD exacerbation
3. Rapid decline of clinical course;
4. Use of a wheelchair;
5. Use of longterm oxygen therapy;
6. A history of astma;
7. Any medical condition that limits the daily activity;
8. Serious psychiatric comorbidity;
9. Participation in a COPD rehabilition program in the previous 3 months;
10. Serious comorbidity with a reduced life expectancy;
11. Restrictive lungdisease (TLC < 80%);
12. A chronic lungdisease other than COPD;
13. A history of myocardial infarction, heartfailure or cardiac arrhythmia in the previous 6 months that requires treatment;
14. Inability to travel to hospital.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jun-2013|
|- planned closingdate||1-feb-2014|
|- Target number of participants||30|
|- Interventions||Metronome-paced tachypnea.|
|- Primary outcome||Rate of dynamic hyperinflation (ΔIC/s):|
Hyperinflation is defined as an increase in the end-expiratory lungvolume (EELV). A decrease in inspiratory capacity (IC) is used as a substitute for the increased EELV. This is based on the assumption that the total lungcapacity (TLC) has to remain constant. An increase of the EELV has to result in a decrease of the IC, because the sum of these parameters composes the TLC (EELV+IC=TLC).
|- Secondary outcome||1. Rate of recovery after DH (ΔIC/s);|
2. The degree of DH (ΔIC);
3. Activity outcome IMA.
To measure physical activity a smartphone (HTC Desire/ HTC Desire S) and a motion sensor (ProMove 3D wireless inertial sensor, Inertia Technology) will be used. The motion sensor is a triaxial accelerometer that measures
acceleration. The average value of the three axes of motion are than calculated and converted into activity outcome IMA.
The outcome measure is calculated with the method of Bouten et al., that can be highly related to energy expenditure. A
change of velocity occurs when a person starts to move and stops to move. The motion sensor connects through a
Bluetooth-connection with a smartphone. Daily activity data is subsequently memorized as activity outcome IMA on the
hard drive of the smartphone. The motion sensor is being carried on the patient’s belt and the smartphone is being kept
near the patient. This method has been approved by the Medical research ethics committee of the Medisch Spectrum
Twente Hospital in Enschede.
|- Trial web site||N/A|
|- 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)
|Medisch Spectrum Twente|
|- Brief summary||This study investigates the relation between DH and activity status in COPD. The central question in this study is if DH induced by MPT can be correlated with the activity status determined with an accelerometer. One of the factors causing dyspnea in COPD patients is DH. Symptomatic patients with COPD are dyspnoic, even during daily activities. This leads to inactivity and subsequently to fysical deconditioning. This results in a vicious circle that affects the quality of life highly. The aim of this study is to gain insight in the relation between DH and the activity status in order that, when it becomes clear what the influence of DH on the activity status is, an estimation can be made of which patients are most at risk of becoming locked in a vicious circle. Consequently, this could be accomodated with an adaptation of lungrehabilitation programs, based on the predisposition in developing DH. With regard to a quality of life, shortness of breath, usage of the healthcare system and mortality could improved. Furthermore, DH is possibly a more sensitive measurement than FEV1 to track consequenses of changes in expiratory airflowobstruction. The FEV1 appears to be an unreliable predictor of patientcentered outcomes, such as physical tolerance, shortness of breath or health related quality of life. This study is a one-group clinical trial. 30 COPD patients will be included. Objective daily activity will be assessed with an accelerometer and expressed in activity outcome IMA. DH will be induced by MPT. DH will be measured as a change in the inspiratory capacity (IC) using Oxycon Pro.|
|- Main changes (audit trail)||- Exclusion criteria 6: “A history of asthma” became “A history of severe asthma”? |
- Start amde end date: 15 August 2013 and 15 April 2014.
- Secondary outcomes: “4. Borgscale (1-10) before and after MPT.”
|- RECORD||26-mrt-2013 - 21-jul-2013|