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

Nouran Hesham Slama Younis

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Combination Product: aerobic exercise + low-level laser therapy; Other: Aerobic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06827171

P.T.REC/012/004935

Details and patient eligibility

About

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.

Full description

The participants will be submitted into two equal groups in numbers:

Group A (Study group) n=20 will receive a low-level laser (scanning laser) combined with an aerobic exercise program for 12 weeks (3 sessions/ week).

Group B (control group) n=20: Who will receive aerobic exercise for 12 weeks (3sessions/week) All patients with their prescribed medications (hypoglycemic, antiplatelet, anticoagulants, antihypertensive, vasodilators, analgesics)

Enrollment: 40 patients

Sex: All

Ages: 55 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Their ages will range from 55- 65 years, for both genders.
• Body Mass Index of 25-29.9kg/m2.
• Glycated hemoglobin (HbA1c) from 7 to 9 %.
• The patient has suffered from diabetes for more than 5 years.
• Patient with mild to moderate PAD on Rutherford classification stages (1-3)

Exclusion criteria

1. Patients with a history of hypo-hyperglycemic coma.
2. Uncontrolled cardiovascular complications, and ischemic heart disease.
3. Photosensitivity, Malignancy, Anemia, Hemorrhagic diseases (contraindication to laser)
4. Deep venous thrombosis, acute thromboses.
5. Cerebrovascular disease.
6. Patients with Monckeberg sclerosis.
7. Patient with resting pain critical limb ischemia, diabetic foot, and peripheral edema, asymptomatic PAD, Diabetic neuropathy.
8. Patient with minor/ or major amputations.
9. A patient with positive smoking

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Study group A: Aerobic exercise+ low-level Laser therapy

Experimental group

Description:

(Study group A): It will receive a low-level laser (scanning laser) on the course of the posterior tibial and anterior tibial artery combined with an aerobic exercise program for peripheral artery disorder for 12 weeks (3 sessions/ week).

Treatment:

Other: Aerobic exercise

Combination Product: aerobic exercise + low-level laser therapy

Control group B: Aerobic Exercise group B

Experimental group

Description:

group B: They will receive aerobic exercise for 12 weeks. aerobic exercise program for peripheral arterial disorders and intermittent claudication.

Treatment:

Other: Aerobic exercise