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Exercise Rehabilitation for Patients With Critical Limb Ischemia After Revascularization

NCT03839953 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-05-28

No results posted yet for this study

Summary

Peripheral arterial disease (PAD) affects more than 200 million people worldwide. This disease occurs with narrowing and occlusion of arteries supplying oxygenated blood to the organs and limbs. Symptomatic patients typically experience leg pain with physical activity. More advanced disease states are referred to as critical limb ischemia (CLI), where patients may have leg pain at rest or non-healing wounds. Primary treatment of PAD involves risk factor management; smoking cessation, management of blood pressure, blood cholesterol, diabetes, and exercise prescription. Patients with CLI typically require interventions to reestablish blood supply to their limbs. There is currently minimal understanding of the role for exercise rehabilitation after revascularization procedures in this vulnerable population. This is the first clinical to understand the role of exercise for these patients. We hypothesize that exercise rehabilitation after revascularization will improve quality of life and functional capacity in these patients.

Conditions

  • Peripheral Arterial Disease
  • Critical Limb Ischemia

Interventions

BEHAVIORAL

Supervised Exercise Program

This intervention is a 12-week supervised exercise program at an established cardiac rehabilitation facility.

OTHER

Best Medical Therapy

After undergoing revascularization for critical limb ischemia, patients will receive best medical therapy under the supervision of a vascular internal medicine specialist. This care will include advice on smoking cessation, physical activity guidelines, blood pressure regulation, statin administration and possible anti-platelet administration.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Randy D Moore, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2020-01-01
Completion
2020-07-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03839953 on ClinicalTrials.gov