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Air to walk.


- candidate number4544
- NTR NumberNTR1542
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-nov-2008
- Secondary IDsMEC 08-3-069 NL24140.068.08
- Public TitleAir to walk.
- Scientific TitleEffects of 2 walking aids on functional mobility in patients with COPD
- ACRONYMN/A
- hypothesisPart 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.

Part 2:
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) studiedChronic Obstructive Pulmonary Disease (COPD), Rehabilitation, Walking
- Inclusion criteria1. 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 criteria1. Neuromuscular disease;
2. Lon-term oxygen therapy;
3. Known joint disease;
4. Cardiac pacemaker.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 24-nov-2008
- planned closingdate30-okt-2009
- Target number of participants48
- InterventionsRollator versus new walking aid (a 'walk-bike').
- Primary outcomePart 1:
Difference in 6-minute walking distance.

Part 2:
Difference in total time to complete an outdoor course of about 1000m.
- Secondary outcomePart 1.
Differences in sperceived symptoms, number of stops, stride length, stride frequency, number of strides, oxygen consumption, ventilation, heart rate and oxygen saturation.

Part 2.
Differences in perceived symptoms, number of stops, stride length, stride frequency, number of strides, heart rate and oxygen saturation.
- TimepointsPart 1+2.
Patients will be asked to walk twice on 2 consequetive days. The walking aids will be used in random order.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Martijn A. Spruit
- CONTACT for SCIENTIFIC QUERIESDr. Martijn A. Spruit
- Sponsor/Initiator University Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
University Hospital Maastricht (AZM)
- PublicationsN/A
- Brief summaryPatients 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)
- RECORD18-nov-2008 - 28-nov-2008


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