Clinical trial NCT06827171: Impact of LLL and Aerobic Exercise on Peripheral Arterial Outcomes in Patients With Type 2 Diabetes
Official title: Impact of Low-level Laser and Aerobic Exercise on Peripheral Arterial Outcomes in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Peripheral artery Disease
Low level laser
Aerobic exercise
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the study is going to contain 2 experimental groups, the first one will receive combined therapy (aerobic exercise program for PAD + low-level laser therapy) the other group will receive aerobic exercise program for PAD only.
Primary purpose: SUPPORTIVE_CARE

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)

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

Primary outcomes:
measure: body mass index
timeFrame: 3 month
measure: peak systolic velocities (PSV)
timeFrame: 3 months
measure: Ankle-Brachial Index (ABI) %
timeFrame: 3 months
measure: The visual analog scale (VAS) questionnaire for pain
timeFrame: 3 months
measure: The Edinburgh Claudication Questionnaire (ECQ)
timeFrame: 3 months
Secondary outcomes:
measure: The initial claudication distance and The absolute claudication distance (meters)
timeFrame: 3 months
measure: Maximum oxygen consumption Vo^2 max ((ml/kg/min))
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: head of physical therapy department for internal medicine, Cairo university.
name: Nesreen Gh EL NAHAS, doctor
role: PRINCIPAL_INVESTIGATOR
References: