Self-Managed Walking Improves Function
Primary Purpose
Peripheral Arterial Disease, Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Self-managed walking
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Walking therapy, Diabetes mellitus, Peripheral arterial disease
Eligibility 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
Sites / Locations
- KU School of Medicine - Wichita
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
The intervention includes individual therapy, group reinforcement, and follow-up phone contact
Attention control group will receive routine follow-up phone calls
Outcomes
Primary Outcome Measures
Maximal treadmill walking distance
Secondary Outcome Measures
Full Information
NCT ID
NCT00611988
First Posted
January 25, 2008
Last Updated
December 9, 2013
Sponsor
University of Kansas
Collaborators
American Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT00611988
Brief Title
Self-Managed Walking Improves Function
Official Title
Self-Managed Walking Improves Function in Patients With Diabetes Mellitus and Peripheral Arterial Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas
Collaborators
American Diabetes Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Diabetes Mellitus
Keywords
Walking therapy, Diabetes mellitus, Peripheral arterial disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
The intervention includes individual therapy, group reinforcement, and follow-up phone contact
Arm Title
2
Arm Type
Active Comparator
Arm Description
Attention control group will receive routine follow-up phone calls
Intervention Type
Behavioral
Intervention Name(s)
Self-managed walking
Other Intervention Name(s)
behavorial intervention
Intervention Description
The intervention includes individual therapy, group reinforcement, and follow-up phone contact
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
Attention control
Intervention Description
Attention control group will receive routine follow-up phone calls
Primary Outcome Measure Information:
Title
Maximal treadmill walking distance
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracie C Collins, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
KU School of Medicine - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21873560
Citation
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.
Results Reference
derived
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