Effects of a Exercise Program on Health Outcomes in People With Diabetic Foot Ulcers



Status:Completed
Conditions:Gastrointestinal, Podiatry, Diabetes, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:11/1/2018
Start Date:January 2017
End Date:June 2018

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Effects of a Community Exercise Program on Physical, Physiological, and Psychosocial Health Outcomes in People With Diabetic Foot Ulcers

People with diabetes are at risk for life altering complications, including diabetic foot
ulcers. To heal a diabetic foot ulcer, people are often required to refrain from bearing
weight on their affected limb for months. These long periods of non-weight bearing can result
in severe physical deconditioning, putting these individuals at risk for further health
decline. The goal of this pilot, randomized controlled trial is to evaluate the effects of a
seated exercise program on clinically meaningful outcomes in people with diabetic foot
ulcers. The long-term aim of this research is to improve overall health and quality of life
in people with complications from diabetes.

People with diabetes are at risk for life-altering complications and comorbidities. One of
the most serious complications is a diabetic foot ulcer, which significantly increases risk
for limb amputation. To heal a diabetic foot ulcer, patients are often instructed to refrain
from bearing weight on the affected limb. This non-weight bearing protocol results in
extended periods of inactivity that can lead to severe physical deconditioning, including
diminished strength, endurance, and flexibility. EnhanceFitness, a community exercise program
designed for older adults, holds classes that can be adapted for people who are non-weight
bearing due to a healing foot ulcer. These exercise classes focus specifically on strength
training, aerobic fitness, and stretching - activities that can counteract progressive
deconditioning in people with diabetic foot ulcer. Health benefits associated with exercise
in people with diabetes are well-established. However, for those experiencing declines in
health and physical function because of healing protocols for a diabetic foot ulcer, the
potential benefits of exercise are not yet known. The proposed project aims to address this
gap in diabetes research.

The long-term goal of this research is to improve the health and quality of life of people
with complications from diabetes. The specific goal of this project is to evaluate the effect
of a seated community exercise program, EnhanceFitness, on clinically-meaningful outcomes in
people with diabetic foot ulcers. Study investigators will recruit people with diabetic foot
ulcers from local wound care clinics and randomly assign them to two groups. The first group
will engage in EnhanceFitness, an existing community fitness program appropriate for people
with weight-bearing restrictions due to wound-healing protocols. The second group will
receive the standard of care, which does not include exercise recommendations. To assess the
effectiveness of the seated exercise program, the investigators will compare important health
outcomes between people with diabetic foot ulcers participating in EnhanceFitness and a
control group with diabetic foot ulcers. Specifically, the investigators will assess physical
and physiological outcomes, including glycated hemoglobin (HbA1c), lower-extremity strength,
and wound healing. The investigators will also measure psychosocial outcomes, such as
depression, perceived physical function, overall health, and self-reported ability to
continue with exercise. Further, the investigators will evaluate the feasibility of
conducting research assessing the effects of seated exercise in people with foot ulcers. The
data collected in this pilot research will be used to apply for large, extramural funding
that aims to mitigate physical deconditioning in people with diabetic foot ulcers.

Inclusion Criteria:

- 18 or more years of age

- diagnosis of type 2 diabetes

- undergoing treatment for a Wagner grade II, III, or IV diabetic foot ulcer

- able to attend regular exercise classes and two data collection sessions

Exclusion Criteria:

- medical conditions where aerobic or resistance exercise is contraindicated (e.g.,
uncontrolled cardiovascular problems)

- a score of less than 18 on the Montreal Cognitive Assessment indicating moderate
cognitive impairment

- response from primary physician requesting that the participant not engage in exercise

- current participation in a regular exercise program (more than 30 minutes, more than 2
times a week)
We found this trial at
1
site
Seattle, Washington 98133
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mi
from
Seattle, WA
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