Micro- and macrovasculair adaptations in patients with peripheral arterial disease during supervised exercise therapy: a MRI study

Micro- and macrovasculair adaptations in patients with peripheral arterial disease during supervised exercise therapy: a MRI study - VAPAD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35278

Enrollment

Registered

2008-05-13

Start date

2008-07-18

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis stenosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •Intermittent claudication according to a psoitive Rose-Edingburgh questionnaire •Rest ankel-brachial pressure index (ABPI)

Exclusion criteria

Exclusion criteria: •Chronic or acute critical ischemia •Treated by or planned for vascular surgery or percutaneous transluminal angioplasty •Recent onset

Design outcomes

Primary

Measure	Time frame
The clinical outcome (i.e. degree of rehabilitation) is expressed in terms of change in maximal and pain free walking distance and quality-of-life. The pain free walking distance will be measured conform the guidelines of the 'inter-society consensus for the management of peripheral arterial disease (TASC II). Following this protocol, the primaire outcome measure consists of the walking distance up until claudicationpain arises.	—

Measure

Time frame

The clinical outcome (i.e. degree of rehabilitation) is expressed in terms of change in maximal and pain free walking distance and quality-of-life. The pain free walking distance will be measured conform the guidelines of the 'inter-society consensus for the management of peripheral arterial disease (TASC II). Following this protocol, the primaire outcome measure consists of the walking distance up until claudicationpain arises.

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Secondary

Measure	Time frame
Changes in painfree walking distance before, after 3 and 6 months of therapy will be related to changes in micro- and macrovasculair adaptations that have been found on MRI assessments. MRI measures will be the degree of stenosis, collateralization, bulk blood flow to the common femoral artery, microvascular blood flow (expressed as Ktrans in mL/min/cm3) and dynamics of oxygen delivery during reactive hyperemia.	—

Measure

Time frame

Changes in painfree walking distance before, after 3 and 6 months of therapy will be related to changes in micro- and macrovasculair adaptations that have been found on MRI assessments. MRI measures will be the degree of stenosis, collateralization, bulk blood flow to the common femoral artery, microvascular blood flow (expressed as Ktrans in mL/min/cm3) and dynamics of oxygen delivery during reactive hyperemia.

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Countries

Netherlands

Outcome results