Self-Managed Walking Improves Function

NCT ID: NCT00611988

Last Updated: 2013-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-09-30

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.

Conditions

Peripheral Arterial Disease; Diabetes Mellitus

Keywords

Walking therapy; Diabetes mellitus; Peripheral arterial disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

The intervention includes individual therapy, group reinforcement, and follow-up phone contact

Group Type: EXPERIMENTAL

Self-managed walking

Intervention Type: BEHAVIORAL

The intervention includes individual therapy, group reinforcement, and follow-up phone contact

2

Attention control group will receive routine follow-up phone calls

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

Attention control group will receive routine follow-up phone calls

Interventions

Self-managed walking

The intervention includes individual therapy, group reinforcement, and follow-up phone contact

Intervention Type: BEHAVIORAL

Control group

Attention control group will receive routine follow-up phone calls

Intervention Type: OTHER

Other Intervention Names

behavorial intervention; Attention control

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

University of Kansas

OTHER

Sponsor Role: lead

Responsible Party

Tracie Collins, MD, MPH

Prinicpal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tracie C Collins, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

KU School of Medicine - Wichita

Wichita, Kansas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21873560 (View on PubMed)

Other Identifiers

7-06-CR-10

Identifier Type: -

Identifier Source: secondary_id

0607M89406

Identifier Type: -

Identifier Source: org_study_id