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Observational study;
Prospective validation study Dutch version walking impairment Questionnaire (WIQ).



- candidate number2822
- NTR NumberNTR1118
- ISRCTNNiet aangevraagd/Observational study
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-okt-2007
- Secondary IDs07-N-62.  METC nummer
- Public TitleObservational study;
Prospective validation study Dutch version walking impairment Questionnaire (WIQ).
- Scientific TitleObservational study;
Prospective validation study Dutch version Walking Impairment Questionnaire (WIQ).
- ACRONYMVALWIQ
- hypothesis1.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) studiedLimb ischemia
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 22-okt-2007
- planned closingdate22-okt-2008
- Target number of participants30
- InterventionsSupervised exercise therapy.
- Primary outcome1. Internal consistency;
2. Test-retest reliability ;
3. Construct validity;
4. Concurrent validity.
- Secondary outcomeDifference in walking ability on a treadmill compared with the walking ability outside at baseline and after three month of supervised exercise therapy.
- TimepointsBaseline and after three months of therapy.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.A.W Teijink
- CONTACT for SCIENTIFIC QUERIESDr. J.A.W Teijink
- Sponsor/Initiator Atrium Medisch Centrum Parkstad
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryBackground
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.


Objective
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.


Methods
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.


Conclusion
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)
- RECORD18-okt-2007 - 12-nov-2008


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