Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286598
Status:
COMPLETED
Last Update Posted:
2016-10-05
First Post:
2006-02-01
Brief Title:
Feet First Promoting Physical Activity Among People With Diabetes Mellitus and Insensate Feet
Sponsor:
University of Missouri-Columbia
Organization:
University of Missouri-Columbia
Study Overview
Official Title:
Feet First Increasing Activity Without Increasing the Risk of Foot Ulcers in People With Diabetes and Insensate Feet
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 Foundations 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
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 Foundations 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
Detailed 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 ie 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 ie 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 ie 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
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 ie 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None