Diabetes Mellitus, Type 2, Diabetic Foot Ulcer
Conditions
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.
Interventions
OTHEREnhanceFitness 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chair Stand Test (5x Sit-to-Stand) at 12-week Session | 12 weeks post-intervention | 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. |
| Glycated Hemoglobin (HbA1c) at 12-week Session | 12 weeks post-intervention | Average blood glucose over a three-month period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-Depression at 12 Weeks | 12 weeks post-intervention | Patient-Reported Outcome Measurement Information System (PROMIS) Depression 4-item short form. Results are reported as a T-score. PROMIS-Depression is a self-reported questionnaire to assess depression. A higher T-score indicates greater depression; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 41.0 to 79.4 for the 4-item short form. |
| PROMIS-Physical Function | 12 weeks post-intervention | Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function 11-item short form. Results are reported as a T-score. PROMIS-Physical Function is a self-reported questionnaire to assess physical function. A higher T-score indicates better physical function; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 11.9 to 57.9 for the 11-item short form. |
| Retention | Through the end of study participation, approximately 12 weeks | Feasibility measure- did the participant attend all study data collection sessions? |
| EnhanceFitness Program Evaluation | 12-weeks post-intervention | Feasibility measure, satisfaction with exercise program for participants in the intervention group. This satisfaction measure was designed by EnhanceFitness. It included 5 items, each item was rated by participants as 1 (not at all satisfied) to 5 (very satisfied). Responses for the five questions were summed and divided by 5. Scores ranged from 1-5, with better scored indicating higher satisfaction. |
| Adverse Events | Through the end of study participation, approximately 12 weeks | Feasibility measure- number of adverse events, if any, that occurred for each participant. |
| Adherence | Through the end of study participation, approximately 12 weeks | Feasibility measure- % classes attended by participants in the intervention group |
| PROMIS-Global at 12-week Session | 12 weeks post-intervention | Patient-Reported Outcome Measurement Information System (PROMIS) Global 10-item short form. Results are reported as a T-score. PROMIS-Global is a self-reported questionnaire to assess global health. T-scores are calculated for 2 subscales- physical health and mental health. A higher T-score indicates better physical health and better mental health; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores for physical health range from 16.2 to 67.7. T-scores for mental health range from 21.2 to 67.6. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 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. |
Countries
United States
Participant flow
Pre-assignment details
Participants were assigned to study group at the time that the baseline appointment was scheduled for logistical reasons (i.e., to facilitate the identification and enrollment in a community-based exercise course if the participant was allocated to the exercise group). 34 participants were allocated to treatment group, but only 24 attended a baseline session and consented to study participation.
Participants by arm
| Arm | Count |
|---|---|
| Exercise EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.
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. | 10 |
| Control Usual care. | 14 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Found to not meet inclusion criteria during baseline session data collection. | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Exercise | Control | Total |
|---|---|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 10 | 57.4 years STANDARD_DEVIATION 11.8 | 58.2 years STANDARD_DEVIATION 10.9 |
| Body mass index | 32.7 kg/m^2 STANDARD_DEVIATION 5.5 | 36.4 kg/m^2 STANDARD_DEVIATION 10.8 | 34.8 kg/m^2 STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 11 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 10 Participants | 14 Participants |
| Region of Enrollment United States | 10 participants | 14 participants | 24 participants |
| Sex/Gender, Customized Gender Men | 6 Participants | 7 Participants | 13 Participants |
| Sex/Gender, Customized Gender Women | 4 Participants | 7 Participants | 11 Participants |
| Time since diabetes diagnosis (self-reported) | 20.0 years STANDARD_DEVIATION 14.8 | 19.1 years STANDARD_DEVIATION 6.8 | 19.5 years STANDARD_DEVIATION 11.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 11 |
| other Total, other adverse events | 0 / 7 | 0 / 11 |
| serious Total, serious adverse events | 0 / 7 | 0 / 11 |
Outcome results
Primary
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.
Time frame: 12 weeks post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise | Chair Stand Test (5x Sit-to-Stand) at 12-week Session | 14.4 seconds | Standard Deviation 2.8 |
| Control | Chair Stand Test (5x Sit-to-Stand) at 12-week Session | 17.1 seconds | Standard Deviation 4.9 |
p-value: 0.38ANOVA
Primary
Glycated Hemoglobin (HbA1c) at 12-week Session
Average blood glucose over a three-month period
Time frame: 12 weeks post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise | Glycated Hemoglobin (HbA1c) at 12-week Session | 8.0 percentage of HbA1c | Standard Deviation 1.7 |
| Control | Glycated Hemoglobin (HbA1c) at 12-week Session | 7.0 percentage of HbA1c | Standard Deviation 1.3 |
p-value: 0.26ANOVA
Secondary
Adherence
Feasibility measure- % classes attended by participants in the intervention group
Time frame: Through the end of study participation, approximately 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise | Adherence | 57.1 percentage of classes attended | Standard Deviation 28.9 |
Secondary
Adverse Events
Feasibility measure- number of adverse events, if any, that occurred for each participant.
Time frame: Through the end of study participation, approximately 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exercise | Adverse Events | 0 adverse events |
| Control | Adverse Events | 0 adverse events |
Secondary
EnhanceFitness Program Evaluation
Feasibility measure, satisfaction with exercise program for participants in the intervention group. This satisfaction measure was designed by EnhanceFitness. It included 5 items, each item was rated by participants as 1 (not at all satisfied) to 5 (very satisfied). Responses for the five questions were summed and divided by 5. Scores ranged from 1-5, with better scored indicating higher satisfaction.
Time frame: 12-weeks post-intervention
Population: Only participants in the exercise arm who attended at least one exercise class (n=6 out of 7 total).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise | EnhanceFitness Program Evaluation | 4.8 score on a scale | Standard Deviation 0.32 |
Secondary
PROMIS-Depression at 12 Weeks
Patient-Reported Outcome Measurement Information System (PROMIS) Depression 4-item short form. Results are reported as a T-score. PROMIS-Depression is a self-reported questionnaire to assess depression. A higher T-score indicates greater depression; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 41.0 to 79.4 for the 4-item short form.
Time frame: 12 weeks post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise | PROMIS-Depression at 12 Weeks | 48.4 T-score | Standard Deviation 8.8 |
| Control | PROMIS-Depression at 12 Weeks | 53.8 T-score | Standard Deviation 8.7 |
p-value: 0.81ANOVA
Secondary
PROMIS-Global at 12-week Session
Patient-Reported Outcome Measurement Information System (PROMIS) Global 10-item short form. Results are reported as a T-score. PROMIS-Global is a self-reported questionnaire to assess global health. T-scores are calculated for 2 subscales- physical health and mental health. A higher T-score indicates better physical health and better mental health; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores for physical health range from 16.2 to 67.7. T-scores for mental health range from 21.2 to 67.6.
Time frame: 12 weeks post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise | PROMIS-Global at 12-week Session | Physical Health | 47.5 T-score | Standard Deviation 7.5 |
| Exercise | PROMIS-Global at 12-week Session | Mental Health | 50.7 T-score | Standard Deviation 10 |
| Control | PROMIS-Global at 12-week Session | Physical Health | 39.2 T-score | Standard Deviation 6.9 |
| Control | PROMIS-Global at 12-week Session | Mental Health | 45.7 T-score | Standard Deviation 9.1 |
Comparison: For PROMIS Global Physicalp-value: 0.24ANOVA
Comparison: For PROMIS Global Mentalp-value: 0.8ANOVA
Secondary
PROMIS-Physical Function
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function 11-item short form. Results are reported as a T-score. PROMIS-Physical Function is a self-reported questionnaire to assess physical function. A higher T-score indicates better physical function; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 11.9 to 57.9 for the 11-item short form.
Time frame: 12 weeks post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise | PROMIS-Physical Function | 44.6 T-score | Standard Deviation 7.2 |
| Control | PROMIS-Physical Function | 37.0 T-score | Standard Deviation 3.2 |
p-value: 0.03ANOVA
Secondary
Retention
Feasibility measure- did the participant attend all study data collection sessions?
Time frame: Through the end of study participation, approximately 12 weeks
Population: This is a feasibility measure of how many people completed the study from baseline to 12 weeks. Thus, the number of patients that completed the baseline session was used.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exercise | Retention | 7 Participants |
| Control | Retention | 11 Participants |
Other Pre-specified
Recruitment
Feasibility measure- were overall recruitment targets reached? This feasibility measure will be assessed for the overall study and not for each participant.
Time frame: At the completion of the 2-year study
Population: 34 is the number randomized to group; 40 is the number that we targeted for this study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exercise | Recruitment | 34 Participants |