|- candidate number||4544|
|- NTR Number||NTR1542|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-nov-2008|
|- Secondary IDs||MEC 08-3-069 NL24140.068.08|
|- Public Title||Air to walk.|
|- Scientific Title||Effects of 2 walking aids on functional mobility in patients with COPD|
|- hypothesis||Part 1: |
Previously, the use of a rollator has been shown to improve functional mobility in patients with COPD. We hypothesize that a new walking aid will result in a larger improvement in 6-minute walking distance as compared to the rollator.
We hypothesize that COPD patients may also improve their functional mobility on an outdoor course of about 1000m by using the new walking aid as compared to a rollator.
|- Healt Condition(s) or Problem(s) studied||Chronic Obstructive Pulmonary Disease (COPD), Rehabilitation, Walking|
|- Inclusion criteria||1. Primary diagnosis: COPD|
2. Unaided 6-minute walking distance <400 meter ;
3. Clinically stable;
4. Signed written informed consent;
5. Capable to communicate in Dutch language.
|- Exclusion criteria||1. Neuromuscular disease;|
2. Lon-term oxygen therapy;
3. Known joint disease;
4. Cardiac pacemaker.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||24-nov-2008|
|- planned closingdate||30-okt-2009|
|- Target number of participants||48|
|- Interventions||Rollator versus new walking aid (a 'walk-bike').|
|- Primary outcome||Part 1:|
Difference in 6-minute walking distance.
Difference in total time to complete an outdoor course of about 1000m.
|- Secondary outcome||Part 1.|
Differences in sperceived symptoms, number of stops, stride length, stride frequency, number of strides, oxygen consumption, ventilation, heart rate and oxygen saturation.
Differences in perceived symptoms, number of stops, stride length, stride frequency, number of strides, heart rate and oxygen saturation.
|- Timepoints||Part 1+2.|
Patients will be asked to walk twice on 2 consequetive days. The walking aids will be used in random order.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. Martijn A. Spruit|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Martijn A. Spruit|
|- Sponsor/Initiator ||University Hospital Maastricht (AZM)|
(Source(s) of Monetary or Material Support)
|University Hospital Maastricht (AZM)|
|- Brief summary||Patients with COPD generally suffer from a limited functional mobility. An improved mobility has been found following the use of a rollator. Nevertheless, we hypothesize that a new walking aid may even be more effective to improve functional mobility by partially unloading the lower limbs by sitting on a 'bike seat'. Nevertheless, this has never been studied.|
|- Main changes (audit trail)|
|- RECORD||18-nov-2008 - 28-nov-2008|