Feet First: Promoting Physical Activity Among People With Diabetes Mellitus and Insensate Feet
Status: | Completed |
---|---|
Conditions: | Neurology, Diabetes |
Therapuetic Areas: | Endocrinology, Neurology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 5/14/2016 |
Start Date: | January 2005 |
End Date: | June 2008 |
Feet First: Increasing Activity Without Increasing the Risk of Foot Ulcers in People With Diabetes and Insensate Feet
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.
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.
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.
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.
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
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University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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