Exercise Rehabilitation for Critical Limb Ischemia Patients After Revascularization: Pilot Randomized Controlled Trial Assessing Functional Capacity and Quality of Life After a 12-week Rehabilitation Program Versus Best Medical Therapy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Calgary
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Rate of enrollment
Study Overview
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.
Detailed Description
Background: Peripheral arterial disease (PAD) refers to narrowing and occlusion of arteries supplying oxygenated blood to non-coronary and non-intracranial circulatory systems. This term is typically used to describe disease in the legs though it also affects upper extremities, renal and mesenteric vessels. Symptomatic patients typically experience leg pain with walking or physical activity which is referred to as intermittent claudication (IC). In more advanced chronic disease states with severely compromised blood flow to the tissues, patients may have leg pain at rest or even non healing wounds that can lead to tissue loss which is defined as critical limb ischemia (CLI).
Risk factor management is critical for PAD patients with the goal of improving symptoms and preventing disease progression. This includes smoking cessation as well as appropriate management for hypertension, dyslipidemia and diabetes. Antiplatelet therapy should be initiated in symptomatic patient or when other risk factors are present. Exercise interventions should be encouraged in all patients with PAD. In patients who have progressed to critical limb ischemia, treatment goals are to relieve pain, heal wounds and prevent limb loss. In addition to risk factor management and medical therapy, these patients require revascularization procedures. Depending on the extent and location of disease, the techniques used may be endovascular/interventional (minimally invasive), surgical, or a hybrid combination of the two.
There has been minimal research examining exercise rehabilitation after revascularization. There are no studies that have focused on exercise rehabilitation exclusively in patients with CLI.
Purpose/Objectives: The aim of this study is to develop a better understanding of the role for supervised exercise rehabilitation programs (SEP) in PAD-CLI patients after revascularization. This pilot study will assess the feasibility for expanding this research to a larger randomized controlled trial.
Study Design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Best Medical Therapy (Other)
Supervised Exercise Program
Patients will receive best medical therapy plus participation in a 12-week supervised exercise program.
Intervention: Supervised Exercise Program (Behavioral)
Outcomes
Primary Outcomes
Rate of enrollment
Time Frame: 3 months
A minimum of 3 patients per month should be enrolled
Functional Capacity
Time Frame: Three months
Functional capacity will be evaluated by a six-minute walk test
Health status assess by SF-36
Time Frame: Three months
36-item self-reported survey that provides a measure of patient health
Quality of Life assessed by VascuQuol questionnaire
Time Frame: Three months
Questionnaire with 25 items validated for patients with peripheral arterial disease
Barriers or experiences with physical activity
Time Frame: Three months
We will conduct a 30-minute interview to gain better understanding of patient experiences with exercise rehabilitation.
Secondary Outcomes
- Major adverse limb events (MALE)(Five years)
Investigators
Randy Moore
Principal Investigator
University of Calgary