Exercise therapy with risk factor management and life style coaching after vascular intervention for patients with peripheral arterial disease with critical limb ischemia or tissue loss.

Exercise therapy with risk factor management and life style coaching after vascular intervention for patients with peripheral arterial disease with critical limb ischemia or tissue loss. - PEARL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39070

Enrollment

Registered

2011-08-10

Start date

2011-11-01

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

critical limb ischemia gangrene

Interventions

The treatment of patients in the intervention group consists of several facets: identification of all cardiovascular risk factors and analysis of adequacy of the chosen therapy. If necessary, refer

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with Rutherford stage 4 and 5 peripheral arterial disease where an open or endovascular intervention is possible to improve the arterial peripheral perfusion.

Exclusion criteria

Exclusion criteria: Servere NYHA 4 comorbidity Below the knee or above the knee amputation contralateral leg No physiotherapy coverd in insurance

Design outcomes

Primary

Measure	Time frame
Primary endpoints: pain free and maximum walking distance, quality of life, illness and pain perception measured with the RAND SF-36, WIQ, and MPQ-DLV.	—

Secondary

Measure	Time frame
Secondary outcome measures: control of cardiovascular risk factors: hypertension, diabetes mellitus, hypercholesterolemia. Lifestyle factors: smoking status, body mass index and waist-hip ratio. Prevalence of confusion and dementia measured by MMSE and DOS. Functioning on ADL level measured by the Katz Index. Also registration of mortality and morbidity, vascular re-interventions, cardiovascular events and hospitalizations and treatments performed by other specialties. All endpoints measured at baseline, 1, 3, 6, 9 and 12 months.	—

Measure

Time frame

Secondary outcome measures: control of cardiovascular risk factors: hypertension, diabetes mellitus, hypercholesterolemia. Lifestyle factors: smoking status, body mass index and waist-hip ratio. Prevalence of confusion and dementia measured by MMSE and DOS. Functioning on ADL level measured by the Katz Index. Also registration of mortality and morbidity, vascular re-interventions, cardiovascular events and hospitalizations and treatments performed by other specialties. All endpoints measured at baseline, 1, 3, 6, 9 and 12 months.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)