Structured Exercise Program for Diabetic Foot

Overseen By Eric J Lew, DPM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Infection, Transplant, Immunocompromised, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The overarching purpose of this study is to investigate the impact that exercise, as delivered through a medically supervised, outpatient cardiac rehabilitation program, has on the wound healing process in Type 2 diabetics having foot ulcers classified as being Wound, Ischemia, foot Infection (WIfI) stage 2 or lower. The criterion reference measure of diabetic foot ulcer wound healing is be the time required to reach the maturation phase of the wound healing cascade (wound closure without drainage).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is a structured exercise program safe for people with diabetes?

Structured exercise programs, including aerobic and strength training, are generally safe for people with diabetes when proper precautions are taken, such as assessing cardiovascular health and monitoring for complications like retinopathy (eye problems) and neuropathy (nerve damage). Serious complications are rare, and regular exercise can improve blood pressure and insulin sensitivity. ^{1 2 3 4 5}

How is the structured exercise program treatment for diabetic foot different from other treatments?

The structured exercise program for diabetic foot is unique because it involves a medically supervised exercise regimen tailored to individuals with diabetes, focusing on both safety and effectiveness. Unlike standard treatments, this program combines resistance and aerobic training to improve cardiovascular health and insulin sensitivity, while being closely monitored to prevent complications. ^{2 3 4 6 7}

What data supports the effectiveness of the treatment Structured Exercise Program for Diabetic Foot?

Research shows that structured exercise programs, including aerobic and resistance training, are effective in improving cardiovascular health and managing diabetes. These programs can enhance insulin sensitivity and blood sugar control, which are beneficial for patients with diabetic complications. ^{4 8 9 10 11}

Research Team

Eric J Lew, DPM

Principal Investigator

University of New Mexico Health Sciences Center

Eligibility Criteria

This trial is for Type 2 diabetics aged 20-80 with foot ulcers (WIfI stage 2 or lower). Participants must have stable blood glucose and HbA1c levels, be able to communicate in English or Spanish, and have reliable transportation. Those with infections, without medical clearance, unable to consent, immunocompromised individuals, or prisoners cannot join.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

My foot ulcer is not severe, graded 2 or less.

I am between 20 and 80 years old.

Exclusion Criteria

I do not have a reliable way to get to UNMH.

I have had a transplant or my immune system is weak.

I currently have an infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive standard wound care and, if in the TAU-EX group, participate in a medically supervised exercise program

12 weeks

2-3 visits per week (in-person)

Follow-up

Participants are monitored for wound healing and safety after the treatment phase

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Structured exercise program

Trial Overview The study tests if a structured exercise program speeds up wound healing in diabetic foot ulcers. It's conducted through an outpatient cardiac rehab setup. The main measure is how quickly the ulcer reaches the maturation phase—meaning it's closed and not draining.

Participant Groups

Group I: Treatment-as-usual plus medically-supervised exercise (TAU-EX) Experimental Treatment 1 Intervention

This group attends normal wound care appointments as scheduled with the wound care provider, generally 2 - 3 times per week. Coincident with these appointments, ideally, they will also attend a medically-supervised exercise program supervised by the exercise physiologists of the Cardiac Rehabilitation facility. The exercise sessions will last no more than 1-hr per session. The maximum number of sessions possibly attended over the 12-wk intervention period is 36. In addition, participants in this group will maintain their activities of daily life unless contraindicated by the would care provider.

Group II: Treat-as-usual (TAU) Active Control 1 Intervention

This group attends normal wound care appointments as scheduled with the wound care provider, generally 2 - 3 times per week. In addition, participants in this group will maintain their activities of daily life unless contraindicated by the would care provider.

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Findings from Research

Exercise training significantly helps in preventing and modifying cardiovascular diseases and reducing mortality, highlighting its importance in patient care.

Patients with acute cardiovascular conditions benefit from structured cardiac rehabilitation programs, while those with chronic conditions should engage in lifelong home-based exercise routines that include aerobic, resistance, flexibility, and balance activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in cardiovascular diseases. Perez-Terzic, CM.[2022]

A specialized unit for prescribing physical exercise has been established for patients with chronic heart failure, post-coronary angioplasty, diabetes, and other cardiovascular conditions, addressing the gap in rehabilitation programs after hospital discharge.

Patients undergo a comprehensive evaluation and then participate in supervised aerobic and resistance training, with ongoing support and reassessment to ensure effective and safe exercise regimens tailored to their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive therapeutic program for cardiovascular patients: role of a sports medicine unit in collaboration with local gymnasiums. Sarto, P., Merlo, L., Astolfo, P., et al.[2016]

Exercise is crucial for managing heart disease, and patients should undergo careful screening to create a safe and effective exercise prescription based on their test results.

Moderate-intensity exercise or exercising under medical supervision is recommended for safety, and these programs have been proven to enhance both the quality and quantity of life for heart disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for the cardiac patient. Long-term maintenance phase. Hartley, LH.[2017]

A structured exercise program conducted three times a week did not succeed in a regional inner-city referral center, indicating challenges in implementing such programs in certain populations.

In response to the need for exercise training, a new 'Therapeutic Walking Program' was developed, highlighting the importance of adapting exercise interventions to better meet patient needs and suggesting areas for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic walking program: an alternative to a formal vascular rehabilitation program. Maune, J.[2004]

The primary principle of exercise prescription is ensuring that the benefits of exercise outweigh any potential risks, particularly for patients with health conditions.

For individuals with diabetic complications, a comprehensive physical examination is essential before starting an exercise program, as daily moderate aerobic exercise can enhance cardiovascular health and improve insulin sensitivity and blood sugar control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise options for people with diabetic eye complications. Scheiner, G.[2004]

Physical activity is crucial for diabetes management, providing benefits like improved blood sugar control, reduced risk of related health issues, and enhanced quality of life for patients with both type 1 and type 2 diabetes.

Caregivers often lack knowledge about exercise recommendations for diabetic patients, which can lead to either unnecessary restrictions on physical activity or increased risk of adverse reactions; therefore, proper assessment of health conditions and safety measures is essential before starting an exercise program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise prescription for diabetics: more than a general recommendation]. Constantini, N., Harman-Boehm, I., Dubnov, G.[2008]

A 12-week tailored exercise program for a patient with severe complications from type 2 diabetes was conducted safely, leading to improvements in muscle strength and daily functioning despite challenges with glycemic control.

The study highlights the importance of a comprehensive medical screening and a multidisciplinary team, including specialists in diabetes and exercise physiology, to ensure safe and effective exercise interventions for patients with diabetic complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use and safety of combined resistance and aerobic training in a patient with complications related to type 2 diabetes: a case report. Otterman, NM., van der Schaaf, M., Busch-Westbroek, TE., et al.[2013]

A 10-year study involving 255 patients with diabetes showed that regular aerobic exercise can be safely implemented in outpatient settings, leading to modest improvements in blood pressure and reduced insulin requirements for those with insulin-dependent diabetes.

Despite some concerns, such as exercise-related proteinuria occurring in 29% of patients, serious complications were rare, indicating that exercise can be an effective part of diabetes management for at least three months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten-year experience with an exercise-based outpatient life-style modification program in the treatment of diabetes mellitus. Schneider, SH., Khachadurian, AK., Amorosa, LF., et al.[2022]

A survey of 104 diabetes patients at the Medical University of Vienna found that 43% were interested in exercise programs, with 23% actually participating, indicating outpatient departments can effectively recruit for such initiatives.

Factors like younger age and better economic status increased participation rates, while gender differences showed that more women expressed interest and participated compared to men, highlighting the need for tailored outreach and more accessible exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment of patients with type 2 diabetes for target group specific exercise programs at an Outpatient Department of a Medical University: A factor analysis. Lackinger, C., Lamprecht, T., Winhofer, Y., et al.[2021]

Regular exercise has long been recognized as a key component of diabetes management, alongside diet and insulin, but research on its specific benefits and risks for diabetic patients has been limited until recently.

There is now a growing interest in defining appropriate exercise prescriptions for diabetic patients, highlighting the importance of exercise as a therapeutic strategy for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and physical training in the treatment of diabetes mellitus. Schneider, SH., Ruderman, NB.[2011]

A 12-week community-based lifestyle program for adults with diabetes or prediabetes showed significant clinical improvements in cardiorespiratory fitness, waist circumference, and exercise behavior, with participants walking an average of 87 meters further in a six-minute test by the end of the program.

The program was well-received, demonstrating good acceptability among participants, and had a low risk of adverse events, suggesting it could be effectively implemented in other communities for similar health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a community-based lifestyle programme for adults with diabetes or pre-diabetes. Higgs, C., Skinner, M., Hale, L.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Exercise in cardiovascular diseases. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Comprehensive therapeutic program for cardiovascular patients: role of a sports medicine unit in collaboration with local gymnasiums. [2016]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise for the cardiac patient. Long-term maintenance phase. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Therapeutic walking program: an alternative to a formal vascular rehabilitation program. [2004]

5. United States pubmed.ncbi.nlm.nih.gov

Exercise options for people with diabetic eye complications. [2004]

6. Israel pubmed.ncbi.nlm.nih.gov

[Exercise prescription for diabetics: more than a general recommendation]. [2008]

7. England pubmed.ncbi.nlm.nih.gov

The use and safety of combined resistance and aerobic training in a patient with complications related to type 2 diabetes: a case report. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Ten-year experience with an exercise-based outpatient life-style modification program in the treatment of diabetes mellitus. [2022]

9. Austria pubmed.ncbi.nlm.nih.gov

Recruitment of patients with type 2 diabetes for target group specific exercise programs at an Outpatient Department of a Medical University: A factor analysis. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Exercise and physical training in the treatment of diabetes mellitus. [2011]

11. Australia pubmed.ncbi.nlm.nih.gov

Outcomes of a community-based lifestyle programme for adults with diabetes or pre-diabetes. [2017]