Impact of LLL and Aerobic Exercise on Peripheral Arterial Outcomes in Patients With Type 2 Diabetes

Summary

Diabetes is one of the fastest-growing diseases worldwide, It has Devastating macrovascular complications (cardiovascular disease) and microvascular complications (such as diabetic kidney disease, diabetic retinopathy, and neuropathy) In Egypt, factors in patients that affect diabetic control include the patient's education and occupation and smoking status. Physical exercise is important for diabetes control. Metformin and investigation availability have a positive association with diabetes control.

Diabetes mellitus increases the risk and accelerates the course of peripheral artery disease, making patients more susceptible to ischemic events and infections and delaying tissue healing. The current understanding of pathogenic mechanisms is mainly based on the negative influence of diabetes mellitus on atherosclerotic disease and inflammation (Fadini et al., 2020).) An early diagnosis of peripheral arterial diseases PAD and correctly identifying patients with Chronic limb-threatening ischemia CLTI are crucial in patients with diabetes to improve outcomes.

Several treatment strategies can be subdivided into lifestyle modification, medical management, endovascular therapies, and surgical interventions for the treatment of PAD.

Exercise training improves walking ability, distances, physical function, and vitality. Physical activity by supervised exercise is recommended in first-line therapy for intermittent claudication by SVS, ESVS, and AHA (Treat-Jacobson et al., 219) More specifically, a supervised exercise program consists of walking a minimum of three times per week (30-60 min/session) for at least 12 weeks Therapeutic laser treatment, also known as low-level laser therapy (LLLT), offers numerous benefits. It is non-surgical, promotes tissue healing, and reduces edema, inflammation, and pain.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

COMBINATION_PRODUCT

aerobic exercise + low-level laser therapy

low- level laser parameters: The wavelength: 808 +/- 5nm The power: output is 450 Mw Type of beam: red laser beam. Beam Divergent \>,025 rad+/- ,005rad Nominal Distance of Sight hazard \>8m The duration: is 20 min for each artery. Treatment period: 3 times/week for 3 months.

OTHER

Aerobic exercise

Aerobic exercise Frequency = 3sessions/week duration: 10 min warm up and 10 min cool down/ 30 min stance phase Intensity: moderate intensity initiating with 50% HR max to end 75% HR max

Sponsors & Collaborators

• Nouran Hesham Slama Younis

  lead OTHER

Principal Investigators

• Nesreen Gh EL NAHAS, doctor · head of physical therapy department for internal medicine, Cairo university.

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-20

Primary Completion

2025-06-30

Completion

2025-06-30

FDA Device

Yes

Countries

• Egypt

Study Locations