Self-Managed Walking Improves Function
2 other identifiers
interventional
145
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2006
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 25, 2008
CompletedFirst Posted
Study publicly available on registry
February 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedDecember 10, 2013
December 1, 2013
3.1 years
January 25, 2008
December 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximal treadmill walking distance
6 months
Study Arms (2)
1
EXPERIMENTALThe intervention includes individual therapy, group reinforcement, and follow-up phone contact
2
ACTIVE COMPARATORAttention control group will receive routine follow-up phone calls
Interventions
The intervention includes individual therapy, group reinforcement, and follow-up phone contact
Attention control group will receive routine follow-up phone calls
Eligibility Criteria
You may qualify if:
- Age 40 years and older
- Diabetes mellitus
- Peripheral arterial disease
- Leg symptoms
You may not qualify if:
- Myocardial infarction within 3 months of enrollment
- Inability to walk for exercise secondary to chest pain, dyspnea, or poor balance
- Prior major amputation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kansaslead
- American Diabetes Associationcollaborator
Study Sites (1)
KU School of Medicine - Wichita
Wichita, Kansas, 67214, United States
Related Publications (1)
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.
PMID: 21873560DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tracie C Collins, MD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicpal investigator
Study Record Dates
First Submitted
January 25, 2008
First Posted
February 11, 2008
Study Start
August 1, 2006
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
December 10, 2013
Record last verified: 2013-12