Exercise Rehabilitation for Patients With Critical Limb Ischemia After Revascularization

NCT03839953 | Unknown

• 1 other identifier: REB17-730
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rehabilitation; Exercise; Revascularization; Endovascular; Vascular Surgery

Outcome Measures

Primary Outcomes (5)

• Rate of enrollment

  A minimum of 3 patients per month should be enrolled

  3 months

• Functional Capacity

  Functional capacity will be evaluated by a six-minute walk test

  Three months

• Quality of Life assessed by VascuQuol questionnaire

  Questionnaire with 25 items validated for patients with peripheral arterial disease

  Three months

• Health status assess by SF-36

  36-item self-reported survey that provides a measure of patient health

  Three months

• Barriers or experiences with physical activity

  We will conduct a 30-minute interview to gain better understanding of patient experiences with exercise rehabilitation.

  Three months

Secondary Outcomes (1)

• Major adverse limb events (MALE)

  Five years

Study Arms (2)

Best Medical Therapy

ACTIVE COMPARATOR

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.

Other: Best Medical Therapy

Supervised Exercise Program

EXPERIMENTAL

Patients will receive best medical therapy plus participation in a 12-week supervised exercise program.

Behavioral: Supervised Exercise Program

Interventions

Supervised Exercise Program BEHAVIORAL

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

Supervised Exercise Program

Best Medical Therapy OTHER

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.

Best Medical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulating prior to procedure
• Living independently prior to procedure
• Available to attend all SEP and follow-up appointments
• PAD Fontaine class III and IV (rest pain and tissue loss)
• Entry with consent of vascular surgeon
• Ischemia secondary to TASC A-D lesions identified on imaging (CTA or angiogram)
• Able to understand and sign informed consent
• \>18 years of age

You may not qualify if:

• Confined to wheelchair
• Patients with exercise tolerance limitations due to other co-morbidities such as cardiorespiratory, musculoskeletal, or peripheral neuropathy. (NYHA class III and IV)
• PAD Fontaine class I and II (asymptomatic, claudication)
• Patients with ongoing tissue loss that limits ambulation
• Patient with previous revascularization procedures
• Patients undergoing revascularization for acute limb ischemia events

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Peter Lougheed Center, Alberta Health Services, University of Calgary

Calgary, Alberta, T1Y 6J4, Canada

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Motor Activity

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Behavior

Study Officials

• Randy D Moore, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 15, 2019
• Study Start: February 15, 2019
• Primary Completion: January 1, 2020
• Study Completion: July 1, 2020
• Last Updated: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)