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

NCT03002155 | Completed Results

• 2 other identifiers: 52222P30DK017047
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Glycated Hemoglobin (HbA1c) at 12-week Session

  Average blood glucose over a three-month period

  12 weeks post-intervention

• Chair Stand Test (5x Sit-to-Stand) at 12-week Session

  Measure of functional mobility and lower extremity strength. The 5x Sit-to-Stand test measures the total amount of time that it takes a individual to stand up and sit down in a chair five times. The individual is asked to stand up and sit down five times as quickly as they are able. The research staff started the stopwatch on "begin" and stopped timing after the individual had completed the fifth round of standing/sitting. Faster times are better, and scores are recorded in seconds.

  12 weeks post-intervention

Secondary Outcomes (7)

• PROMIS-Global at 12-week Session

  12 weeks post-intervention

• PROMIS-Depression at 12 Weeks

  12 weeks post-intervention

• PROMIS-Physical Function

  12 weeks post-intervention

• Retention

  Through the end of study participation, approximately 12 weeks

• Adherence

  Through the end of study participation, approximately 12 weeks

Other Outcomes (1)

• Recruitment

  At the completion of the 2-year study

Study Arms (2)

Exercise

EXPERIMENTAL

EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.

Other: EnhanceFitness community exercise program

Control

NO INTERVENTION

Usual care.

Interventions

EnhanceFitness community exercise program OTHER

Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.

Also known as: Seated Exercise, Group exercise, Fitness program

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Northwest Hospital

Seattle, Washington, 98133, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Sara Morgan, PhD
• Organization: University of Washington (affiliation)

sjmorgan@uw.edu

651-229-1719

Study Officials

• Sara J Morgan, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Assistant Professor, Dept. of Rehabilitation Medicine

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 23, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 6, 2022
• Results First Posted: October 6, 2022

Record last verified: 2022-09

Locations

US (1)