Self-Managed Walking Improves Function
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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 |
- 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 |
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| United States, Minnesota | |
| University of Minnesota - General Clinical Research Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: | Tracie C Collins, MD | University of Minnesota - Clinical and Translational Science Institute |
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: | September 21, 2012 |
| 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 May 19, 2013