Feet First: Promoting Physical Activity Among People With Diabetes Mellitus and Insensate Feet

NCT00286598 | Completed Phase 1 DMC

• 1 other identifier: UMHS IRB 1040047
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The role of weight-bearing physical activity in the development of diabetic foot ulcers remains poorly understood. Regular participation in moderately intense physical activity (e.g. brisk walking ) reduces 8-year cardiovascular mortality in those with diabetes mellitus by over 30%. The American Diabetes Association (ADA) recommends at least 30 minutes of daily moderate intensity activity for people with diabetes. However, the ADA recommends that people with diabetes and insensate feet, which affects up to 40% of those with diabetes, should limit their walking because of concerns that walking could increase the risk of foot ulcers and amputation. Firm evidence is lacking to support these concerns; in fact, while a research fellow I conducted an observational study that showed daily weight-bearing activity may reduce the risk of foot ulceration among people with diabetic foot problems. A controlled clinical trial is needed to study these issues further. The present study is a randomized controlled trial in 100 older adults with diabetes and insensate feet, 50 of whom will participate in an individually-tailored behavior-change intervention called "Feet First", and 50 of whom will be controls. The intervention is based on the extensively-tested CHAMPS model used by the Robert Wood Johnson Foundation's Active for Life Program. Feet First extends the target population beyond older adults generally to people with insensate feet due to diabetic peripheral neuropathy. The specific aims of the study are:

• To determine whether Feet First intervention subjects achieve a greater increase in weight-bearing activity than control subjects, and
• To obtain preliminary evidence on intervention subjects' foot outcomes (foot function, foot-related self-care, and risk of foot ulcers), compared to control subjects.

Conditions

Diabetes Mellitus; Peripheral Neuropathies

Keywords

foot ulcer; diabetes mellitus; motor activity; randomized controlled trial; prevention

Outcome Measures

Primary Outcomes (1)

• Change in weight-bearing physical activity (steps/day)

  Baseline, 3, 6 and 12 months post-enrollment

Secondary Outcomes (4)

• Partial or greater depth foot ulcer (Wagner Gr. 1 or deeper)

  continuously post-enrollment for 12 months

• Falls

  continuously post-enrollment for 12 months

• Self-reported foot disability

  baseline, 6 and 12 months post enrollment

• Foot-related self-care

  baseline, 6 and 12 months post enrollment

Study Arms (2)

Feet First

EXPERIMENTAL

Phase 1: (enrollment to 3 months) 8 sessions with a physical therapist learning leg strengthening and balance exercises, and initiating a walking program Phase 2: Motivational enhancement calls from a nurse every 2 weeks.

Behavioral: Feet First

Control

NO INTERVENTION

Usual care

Interventions

Feet First BEHAVIORAL

Phase 1: (enrollment to 3 months) 8 sessions with a physical therapist learning leg strengthening and balance exercises, and initiating a walking program Phase 2: Motivational enhancement calls from a nurse every 2 weeks.

Feet First

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed type 1 or 2 diabetes mellitus
• Age 50 years or older
• Absent 5.07 Semmes Weinstein monofilament sensation to \> 1 point on both feet
• Residence within 50 miles of Columbia, MO
• Functioning telephone service
• Not currently participating in 20 or more minutes of moderately intense activity more than twice a week

You may not qualify if:

• Hospitalization in the last year for any of the following reasons:
• Proliferative diabetic retinopathy
• Accelerated hypertension (systolic BP \>200 or diastolic BP \> 120)
• Myocardial infarction or unstable angina
• New hemodynamically significant arrhythmia
• Acute congestive heart failure
• Failure to attend 3 of the last 5 scheduled clinic visits
• Foot deformities requiring a custom shoe
• "Timed Up and Go" test 3 \> 15 seconds Subjects unable to ambulate without assistance
• Severe cardiac autonomic neuropathy
• Lower extremity amputation \> one digit
• Heart, kidney or other transplant
• Currently unhealed foot ulcer (or healed for less than 1 month

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (1)

• Kruse RL, Lemaster JW, Madsen RW. Fall and balance outcomes after an intervention to promote leg strength, balance, and walking in people with diabetic peripheral neuropathy: "feet first" randomized controlled trial. Phys Ther. 2010 Nov;90(11):1568-79. doi: 10.2522/ptj.20090362. Epub 2010 Aug 26.

  PMID: 20798179 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Peripheral Nervous System Diseases; Foot Ulcer; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Behavior

Study Officials

• Joseph W LeMaster, MD, MPH

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2006
• First Posted: February 3, 2006
• Study Start: January 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2008
• Last Updated: October 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)