|- candidate number||2822|
|- NTR Number||NTR1118|
|- ISRCTN||Niet aangevraagd/Observational study|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-okt-2007|
|- Secondary IDs||07-N-62. METC nummer |
|- Public Title||Observational study;|
Prospective validation study Dutch version walking impairment Questionnaire (WIQ).
|- Scientific Title||Observational study;|
Prospective validation study Dutch version Walking Impairment Questionnaire (WIQ).
|- hypothesis||1.The Dutch version of the walking impairment questionnaire is a valid instrument for measuring walking disability in patients with peripheral arterial disease;|
2.There is a difference between the walking ability experienced by patients on a treadmill and in daily life.
|- Healt Condition(s) or Problem(s) studied||Limb ischemia|
|- Inclusion criteria||1. Peripheral arterial disease, stage 2 according to Fontaine;|
2. patients starting with supervised exercise therapy;
3. a maximal walking distance of < 750 meter, measured on a treadmill (using a progressive protocol of 3.2 km/h starting with 0% incline, increasing 2% every 2 minutes);
4. informed consent.
|- Exclusion criteria||1. Peripheral arterial disease (stage 3 or 4 acoording to Fontaine);|
2. severe cardiopulmonary comorbidities (NYHA 3 or 4);
3. insufficient knowledge of the Dutch language;
4. unable to walk on a treadmill;
5. unable to walk without walking appliances;
6. familiar with supervised exercise therapy.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||22-okt-2007|
|- planned closingdate||22-okt-2008|
|- Target number of participants||30|
|- Interventions||Supervised exercise therapy.|
|- Primary outcome||1. Internal consistency;|
2. Test-retest reliability ;
3. Construct validity;
4. Concurrent validity.
|- Secondary outcome||Difference in walking ability on a treadmill compared with the walking ability outside at baseline and after three month of supervised exercise therapy.
|- Timepoints||Baseline and after three months of therapy.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.A.W Teijink|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.A.W Teijink|
|- Sponsor/Initiator ||Atrium Medisch Centrum Parkstad|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background|
The Walking Impairment Questionnaire (WIQ) is a questionnaire, often used in peripheral arterial disease studies. A disadvantage for the Dutch situation is that the distances asked in this questionnaire are measured in “Feet” and “Blocks”. A validation of the Dutch version which is culturally adapted to the Dutch situation seems required.
There seems to be a discrepancy between walking ability on the treadmill and the walking ability experienced by patients in daily life. Therefore, the Dutch version of the WIQ will also be validated with a walking-outside-test.
All patients with intermittent claudication receive supervised exercise therapy to improve their walking distances. To examine if the Dutch WIQ is capable of measuring therapy effect, all measurements will be repeated after 3 months of supervised exercise therapy.
Main goal of this study is the validation of the Dutch version of the WIQ at baseline and after three months of supervised exercise therapy.
Patients with peripheral arterial disease, stage 2 according to Fontaine, will have to answer three questionnaires and perform two walking tests; one on a treadmill and one outside before starting supervised exercise therapy and 3 months thereafter.
This study will provide insight in the validity and reliability of the Dutch version of the WIQ before the start of supervised exercise therapy as well as after three months of therapy.
|- Main changes (audit trail)|
|- RECORD||18-okt-2007 - 12-nov-2008|