Expired Study
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Wichita, Kansas 67214


Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

0607M89406


NCT ID:

NCT00611988


Secondary ID:

7-06-CR-10


Study Acronym:


Brief Title:

Self-Managed Walking Improves Function


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Kansas


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

145


Enrollment Type:

Actual


Overall Contact Information

Official Name:Tracie C Collins, MD
Principal Investigator
University of Kansas

Study Dates

Start Date:August 2006
Completion Date:September 2009
Completion Type:Actual
Primary Completion Date:September 2009
Primary Completion Type:Actual
Verification Date:December 2013
Last Changed Date:December 9, 2013
First Received Date:January 25, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Maximal treadmill walking distance
Time Frame:6 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Self-managed walking
Description:The intervention includes individual therapy, group reinforcement, and follow-up phone contact
Arm Name:1
Other Name:behavorial intervention
Intervention Type:Other
Name:Control group
Description:Attention control group will receive routine follow-up phone calls
Arm Name:2
Other Name:Attention control

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Attention control group will receive routine follow-up phone calls
Study Arm Type:Experimental
Arm Name:1
Description:The intervention includes individual therapy, group reinforcement, and follow-up phone contact

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Kansas
Agency Class:Other
Agency Type:Collaborator
Agency Name:American Diabetes Association

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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