Impact of Low-level Laser and Aerobic Exercise on Peripheral Arterial Outcomes in Patients With Type 2 Diabetes
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- body mass index
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Their ages will range from 55- 65 years, for both genders.
- •Body Mass Index of 25-29.9kg/m
- •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
- •Patients with a history of hypo-hyperglycemic coma.
- •Uncontrolled cardiovascular complications, and ischemic heart disease.
- •Photosensitivity, Malignancy, Anemia, Hemorrhagic diseases (contraindication to laser)
- •Deep venous thrombosis, acute thromboses.
- •Cerebrovascular disease.
- •Patients with Monckeberg sclerosis.
- •Patient with resting pain critical limb ischemia, diabetic foot, and peripheral edema, asymptomatic PAD, Diabetic neuropathy.
- •Patient with minor/ or major amputations.
- •A patient with positive smoking
Outcomes
Primary Outcomes
body mass index
Time Frame: 3 month
Body mass index (Kg/M\^2): by dividing the weight by kilogram over Height by meter square.
peak systolic velocities (PSV)
Time Frame: 3 months
Duplex ultrasonography of the lower extremity arteries, from common femoral to pedal arteries is used to measure PSV * Peak systolic velocities (PSV) were recorded in meters per second (Ugwu et al., 2021). * The normal peak systolic velocity (PSV) in peripheral lower limb arteries varies from 45-180 cm/s (Abdelrahman, 2010). Severe arterial disease manifests as a PSV over 200 cm/s, monophasic waveform, and spectral broadening of the Doppler waveform.
Ankle-Brachial Index (ABI) %
Time Frame: 3 months
• Ankle-Brachial Index (ABI) is a ratio of the highest ankle systolic blood pressure obtained in the anterior tibial/ dorsalis pedis or posterior tibial artery to that of the highest brachial systolic pressure. An ABI \< 0.9 was diagnostic of PAD and values were stratified according to severity as: * 0.7-0.89 = mild arterial obstruction. * 0.5-0.69 = moderate arterial obstruction. * ≤ 0.5 = severe arterial obstruction.
The visual analog scale (VAS) questionnaire for pain
Time Frame: 3 months
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." Delgado etal., 2018). * no pain (0-4 mm) * mild pain(5-44 mm) * moderate pain (45-74 mm) * severe pain (75-100 mm). (Weigl K et al., 2021)
The Edinburgh Claudication Questionnaire (ECQ)
Time Frame: 3 months
The Edinburgh Claudication Questionnaire (ECQ) Definition of positive classification requires all of the following responses: \\Yes" to (1), \\No" to (2), \\Yes" to (3), Grade 1 \\No" to (4), and Grade 2 \\Yes" to (4). If these criteria are met, a typical claudicant is one who indicates the pain is in the calf, regardless of whether the pain is also marked at other sites; a diagnosis of atypical claudication is made when the pain is marked in the thigh or buttock, in the absence of any calf pain. Subjects should not be diagnosed with claudication if the pain is indicated in the hamstrings, feet, shins, and joints, or radiates in the absence of any calf pain
Secondary Outcomes
- The initial claudication distance and The absolute claudication distance (meters)(3 months)
- Maximum oxygen consumption Vo^2 max ((ml/kg/min))(3 months)
Investigators
Nouran Hesham Slama Younis
Clinical investigator, police hospital, Egypt
Cairo University