Self-Managed Walking Improves Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00611988
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : December 10, 2013
American Diabetes Association
Information provided by (Responsible Party):
Tracie Collins, MD, MPH, University of Kansas

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Diabetes Mellitus Behavioral: Self-managed walking Other: Control group Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self-Managed Walking Improves Function in Patients With Diabetes Mellitus and Peripheral Arterial Disease
Study Start Date : August 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
The intervention includes individual therapy, group reinforcement, and follow-up phone contact
Behavioral: Self-managed walking
The intervention includes individual therapy, group reinforcement, and follow-up phone contact
Other Name: behavorial intervention

Active Comparator: 2
Attention control group will receive routine follow-up phone calls
Other: Control group
Attention control group will receive routine follow-up phone calls
Other Name: Attention control

Primary Outcome Measures :
  1. Maximal treadmill walking distance [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00611988

United States, Kansas
KU School of Medicine - Wichita
Wichita, Kansas, United States, 67214
Sponsors and Collaborators
University of Kansas
American Diabetes Association
Principal Investigator: Tracie C Collins, MD University of Kansas Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tracie Collins, MD, MPH, Prinicpal investigator, University of Kansas Identifier: NCT00611988     History of Changes
Other Study ID Numbers: 0607M89406
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by Tracie Collins, MD, MPH, University of Kansas:
Walking therapy
Diabetes mellitus
Peripheral arterial disease

Additional relevant MeSH terms:
Diabetes Mellitus
Peripheral Arterial Disease
Peripheral Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases