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

Diabetes Mellitus Clinical Trial

Official title:

Feet First: Increasing Activity Without Increasing the Risk of Foot Ulcers in People With Diabetes and Insensate Feet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286598
• Other study ID #: UMHS IRB 1040047
• Status: Completed
• Phase: Phase 1
• First received: February 1, 2006
• Last updated: October 4, 2016
• Start date: January 2005
• Est. completion date: June 2008

Study information

• Verified date: October 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Physical activity is a vital component of self-management for patients with diabetes mellitus, yet there are special problems in patients whose disease is complicated by insensate feet (i.e. loss of protective sensation caused by diabetic distal symmetric sensory peripheral neuropathy). Foot ulcers develop in 15% of the 17 million people in the United States with diabetes mellitus, and contribute to 84% of foot or toe amputations. Foot ulcer risk is very high among those with insensate feet. Although the roles of neuropathy, plantar foot pressure, and footwear in foot ulcers have been extensively studied, the independent role of physical activity has not. The overall goal of this study is to determine whether a "lifestyle" physical activity intervention, based on the Second Community Healthy Activities Model Program for Seniors (CHAMPS II), which we call FEET FIRST, can be used to safely increase moderate-intensity physical activity (achieving at least 40% of maximal oxygen consumption, as in walking briskly) among people with diabetes and insensate feet. "Lifestyle" physical activity interventions help participants to accumulate at least 30 minutes of self-selected activities in short bouts during the day. CHAMPS II effectively and safely increased physical activity in sedentary older adults with multiple chronic illnesses.

Substantial research has also found that people with diabetic peripheral neuropathy are also at increased risk of falls. Diabetic peripheral neuropathy also leads to postural instability, i.e. impairment in measures of functional dynamic balance. Moreover, this instability worsens with age. People with diabetic peripheral neuropathy in particular tend to have ankle instability due to decreased proprioception, making them less able to rapidly recover balance during sudden ankle dorsiflexion, inversion or eversion when walking on uneven surfaces.

There is ample evidence that promotion of an active lifestyle and specific exercises targeting endurance, strength and balance improves reduces functional decline in the elderly, and that home-based exercise programs effectively decrease fall risk in the elderly as well. One small, non-randomized trial found preliminary evidence that a 3-week intervention that focused on ankle strength improved balance measures in those with diabetic peripheral neuropathy. However, no randomized studies have investigated the effect of a physical activity intervention on fall risk in community-dwelling people with diabetic peripheral neuropathy, who may also be at increased risk of cutaneous injuries (i.e. foot lesions) during weight-bearing activity. Before we unequivocally recommend to people with diabetic peripheral neuropathy that they engage in exercise, we need to determine that this will be safe for their feet, and not increase fall risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Peripheral Nervous System Diseases
• Peripheral Neuropathies

Intervention

Behavioral:
• Feet First
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.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight-bearing physical activity (steps/day)		Baseline, 3, 6 and 12 months post-enrollment	No
Secondary	Partial or greater depth foot ulcer (Wagner Gr. 1 or deeper)		continuously post-enrollment for 12 months	Yes
Secondary	Falls		continuously post-enrollment for 12 months	No
Secondary	Self-reported foot disability		baseline, 6 and 12 months post enrollment	No
Secondary	Foot-related self-care		baseline, 6 and 12 months post enrollment	No