Self-Managed Walking Improves Function

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Tracie Collins, MD, MPH, University of Kansas
ClinicalTrials.gov Identifier:
NCT00611988
First received: January 25, 2008
Last updated: December 9, 2013
Last verified: December 2013
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self-Managed Walking Improves Function in Patients With Diabetes Mellitus and Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Maximal treadmill walking distance [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: August 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611988

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

No publications provided by University of Kansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tracie Collins, MD, MPH, Prinicpal investigator, University of Kansas
ClinicalTrials.gov Identifier: NCT00611988     History of Changes
Other Study ID Numbers: 0607M89406, 7-06-CR-10
Study First Received: January 25, 2008
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014