Clinical trial NCT03002155: Effects of a Exercise Program on Health Outcomes in People With Diabetic Foot Ulcers
Official title: Effects of a Community Exercise Program on Physical, Physiological, and Psychosocial Health Outcomes in People With Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Diabetes Mellitus, Type 2
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-12-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Glycated Hemoglobin (HbA1c) at 12-week Session
timeFrame: 12 weeks post-intervention
measure: Chair Stand Test (5x Sit-to-Stand) at 12-week Session
timeFrame: 12 weeks post-intervention
Secondary outcomes:
measure: PROMIS-Global at 12-week Session
timeFrame: 12 weeks post-intervention
measure: PROMIS-Depression at 12 Weeks
timeFrame: 12 weeks post-intervention
measure: PROMIS-Physical Function
timeFrame: 12 weeks post-intervention
measure: Retention
timeFrame: Through the end of study participation, approximately 12 weeks
measure: Adherence
timeFrame: Through the end of study participation, approximately 12 weeks
measure: EnhanceFitness Program Evaluation
timeFrame: 12-weeks post-intervention
measure: Adverse Events
timeFrame: Through the end of study participation, approximately 12 weeks
Other outcomes:
measure: Recruitment
timeFrame: At the completion of the 2-year study
Locations:
city: Seattle
country: United States
facility: Northwest Hospital
state: Washington
Study officials:
affiliation: University of Washington
name: Sara J Morgan, PhD
role: PRINCIPAL_INVESTIGATOR
References: