Self-Managed Walking Improves Function

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611988
• Other study ID #: 0607M89406
• Secondary ID: 7-06-CR-10
• Status: Completed
• Phase: Phase 2
• First received: January 25, 2008
• Last updated: December 9, 2013
• Start date: August 2006
• Est. completion date: September 2009

Study information

• Verified date: December 2013
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Behavioral:
• Self-managed walking
The intervention includes individual therapy, group reinforcement, and follow-up phone contact

Other:
• Control group
Attention control group will receive routine follow-up phone calls

Locations

Country	Name	City	State
United States	KU School of Medicine - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal treadmill walking distance		6 months	No