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

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ClinicalTrials.gov Identifier: NCT03002155
Recruitment Status : Completed
First Posted : December 23, 2016
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Sara Morgan, University of Washington

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Diabetes Mellitus, Type 2 Other: EnhanceFitness community exercise program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of a Community Exercise Program on Physical, Physiological, and Psychosocial Health Outcomes in People With Diabetic Foot Ulcers
Study Start Date : January 2017
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.
Other: EnhanceFitness community exercise program
Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.
Other Names:
  • Seated Exercise
  • Group exercise
  • Fitness program

No Intervention: Control
Usual care.



Primary Outcome Measures :
  1. Change in Glycated Hemoglobin (HbA1c) [ Time Frame: Baseline and 12 weeks post-intervention ]
    Blood test

  2. Change in Chair Stand Test [ Time Frame: Baseline and 12 weeks post-intervention ]
    Measure of functional mobility and lower extremity strength

  3. Change in wound area measurement [ Time Frame: Baseline and 12 weeks post-intervention ]
    The area (length x width) of the wound measured in square centimeters


Secondary Outcome Measures :
  1. Change in PROMIS-Global [ Time Frame: Baseline and 12 weeks post-intervention ]
    Measure of global health

  2. Change in PROMIS-Depression [ Time Frame: Baseline and 12 weeks post-intervention ]
    Measure of depression

  3. Change in PROMIS-Physical Function [ Time Frame: Baseline and 12 weeks post-intervention ]
    Measure of physical function

  4. Change in Exercise Self-Efficacy Scale [ Time Frame: Baseline and 12 weeks post-intervention ]
    Measure of future ability to perform exercise

  5. Retention [ Time Frame: Through the end of study participation, approximately 12 weeks ]
    Feasibility measure- did the participant attend all study data collection sessions?

  6. Adherence [ Time Frame: Through the end of study participation, approximately 12 weeks ]
    Feasibility measure- % classes attended by participants in the intervention group

  7. EnhanceFitness Program Evaluation [ Time Frame: 12-weeks post-intervention ]
    Feasibility measure, satisfaction with exercise program for participants in the intervention group.

  8. Adverse events [ Time Frame: Through the end of study participation, approximately 12 weeks ]
    Feasibility measure- number of adverse events, if any, that occurred for each participant.


Other Outcome Measures:
  1. Recruitment [ Time Frame: At the completion of the 2-year study ]
    Feasibility measure- were overall recruitment targets reached? This feasibility measure will be assessed for the overall study and not for each participant.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002155


Locations
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United States, Washington
Northwest Hospital
Seattle, Washington, United States, 98133
Sponsors and Collaborators
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Sara J Morgan, PhD University of Washington

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Responsible Party: Sara Morgan, Acting Assistant Professor, Dept. of Rehabilitation Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT03002155     History of Changes
Other Study ID Numbers: 52222
P30DK017047 ( U.S. NIH Grant/Contract )
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetes Mellitus, Type 2
Ulcer
Pathologic Processes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies
Foot Diseases