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

January 25, 2008
December 9, 2013
August 2006
September 2009   (final data collection date for primary outcome measure)
Maximal treadmill walking distance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00611988 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Self-Managed Walking Improves Function
Self-Managed Walking Improves Function in Patients With Diabetes Mellitus and Peripheral Arterial Disease

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Peripheral Arterial Disease
  • Diabetes Mellitus
  • Behavioral: Self-managed walking
    The intervention includes individual therapy, group reinforcement, and follow-up phone contact
    Other Name: behavorial intervention
  • Other: Control group
    Attention control group will receive routine follow-up phone calls
    Other Name: Attention control
  • Experimental: 1
    The intervention includes individual therapy, group reinforcement, and follow-up phone contact
    Intervention: Behavioral: Self-managed walking
  • Active Comparator: 2
    Attention control group will receive routine follow-up phone calls
    Intervention: Other: Control group
Collins TC, Lunos S, Carlson T, Henderson K, Lightbourne M, Nelson B, Hodges JS. Effects of a home-based walking intervention on mobility and quality of life in people with diabetes and peripheral arterial disease: a randomized controlled trial. Diabetes Care. 2011 Oct;34(10):2174-9. doi: 10.2337/dc10-2399. Epub 2011 Aug 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00611988
0607M89406, 7-06-CR-10
No
Tracie Collins, MD, MPH, University of Kansas
University of Kansas
American Diabetes Association
Principal Investigator: Tracie C Collins, MD University of Kansas
University of Kansas
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP