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

NCT ID: NCT06827171

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2025-06-30

Brief 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.

Detailed 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)

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

(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).

Group Type: EXPERIMENTAL

aerobic exercise + low-level laser therapy

Intervention Type: COMBINATION_PRODUCT

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.

Aerobic exercise

Intervention Type: OTHER

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

Control group B: Aerobic Exercise group B

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

Group Type: EXPERIMENTAL

Aerobic exercise

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nouran Hesham Slama Younis

OTHER

Sponsor Role: lead

Responsible Party

Nouran Hesham Slama Younis

Clinical investigator, police hospital, Egypt

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nesreen Gh EL NAHAS, doctor

Role: PRINCIPAL_INVESTIGATOR

head of physical therapy department for internal medicine, Cairo university.

Locations

Cairo University

Cairo, Egypt, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004935

Identifier Type: -

Identifier Source: org_study_id