Self-Managed Walking Improves Function

Study Overview
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Brief Summary
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We are conducting a clinical research trial to determine the role of self-managed walking therapy to improve walking ability in patients with diabetes mellitus and peripheral arterial disease (PAD). PAD, commonly referred to as poor circulation in the legs, is a very common disease in patients with diabetes mellitus. For patients with PAD, there is a significant risk for poor walking ability and limb loss. One major treatment for PAD is walking therapy but the traditional methods for the delivery of this treatment have required frequent visits to a university or hospital-based site. We will address the role of self-managed walking program, to be conducted at or near the home, to improve limb function.

Detailed Description
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Peripheral arterial disease (PAD) is a prevalent illness that affects 12% of U.S adults. Diabetes mellitus is one of the strongest atherosclerotic risk factors for this disease. Among patients with diabetes mellitus, the prevalence of PAD is as high as 29%. An underutilized component of care for PAD is walking therapy. Walking has specifically been shown to improve functional status in patients with PAD and leg symptoms. Leg symptoms in PAD include intermittent claudication and atypical leg symptoms (leg discomfort other than intermittent claudication). Patients with symptomatic PAD have impaired lower extremity functioning, which clinically manifests as slower walking speed, reduced walking distance, and lower physical activity levels. These functional deficits often hinder the ability to live independently in the community (e.g., walking to the bus stop in time for the next bus, shopping independently for groceries). Reduced physical activity is associated with an increased risk for mobility loss and a higher risk for functional decline with subsequent inability to perform activities of daily living. Walking therapy should not be a burden and it should be something that the patient can routinely perform without the need for regular supervision, a treadmill, or to report to the hospital (i.e., self-managed walking therapy). As patients with diabetes mellitus have special needs for self-management behavior (e.g., diet, medication adherence) and, for those with PAD, a higher burden of atypical leg symptoms, the role of a self-managed walking program specific to this group of PAD patients cannot be overemphasized. Thus, this clinical trial has 2 novel aspects: 1) to evaluate the role of self-managed walking therapy for patients with symptomatic PAD and 2) to focus on patients with PAD and diabetes mellitus.

Official Title
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Self-Managed Walking Improves Function in Patients With Diabetes Mellitus and Peripheral Arterial Disease

Conditions
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Peripheral Arterial Disease, Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Self-managed walking
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 years and older Diabetes mellitus Peripheral arterial disease Leg symptoms Exclusion Criteria: Myocardial infarction within 3 months of enrollment Inability to walk for exercise secondary to chest pain, dyspnea, or poor balance Prior major amputation

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>The intervention includes individual therapy, group reinforcement, and follow-up phone contact | Behavioral: Self-managed walking<br>* The intervention includes individual therapy, group reinforcement, and follow-up phone contact<br>* Other names: behavorial intervention;|
| Active Comparator: 2<br>Attention control group will receive routine follow-up phone calls | Other: Control group<br>* Attention control group will receive routine follow-up phone calls<br>* Other names: Attention control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal treadmill walking distance |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walking therapy, Diabetes mellitus, Peripheral arterial disease