Peripheral Arterial Disease
Conditions
Brief summary
Forty patients of both sexes, aged between 50 and 60 years, were chosen from an outpatient vascular clinic in the El Sahel Education Hospital. Patients have been examined and referred to by a vascular specialist.
Detailed description
The participants were divided randomly into two groups of equal numbers. The study group got low-frequency TENS (4 Hz frequency, pulse duration 200 μs) which was administered through surface electrodes for 45 min per session, supramaximal stimulation for T12, L1, and L2 sympathetic ganglions that innervate the lower extremity for 45 min per session, three times per week and for 12 weeks. Control Group that received placebo stimulation as provided by the same TENS device but with a zero volt after 10 s of stimulation.
Interventions
DEVICETranscutaneous Electrical Nerve Stimulation(TENS) device
The Patients in group (A) received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs,burst mode) was be applied through 2 output channels surface electrodes with an E2 TENS device, for 45 min per session, supramaximal stimulation to sympathetic ganglions in T12, L1, and L2, which innervate the lower extremity . For 45 min per session, three times per week, and for 12 weeks.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Unilateral Leriche-Fontaine stage-II PAD 2. Both sexes 3. Aged 50 to 60 years 4. Outpatients 5. Clinically stable 6. Sedentary 7. Not participating in any physical activity last 3 months
Exclusion criteria
1. Walking disorders related to orthopedic or neuromuscular disease 2. Renal insufficiency requiring dialysis (Renal diseases) 3. Known and documented myopathy 4. Progressive cancer 5. Associated progressive disease causing a deterioration in general health 6. Participation in another research protocol 7. Skin disorder making it impossible to use TENS 8. Absolute contraindication to physical activity 9. Presence of a pacemaker/defibrillator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Red cell distribution width (RDW) | change from baseline to after 12 weeks | Peripheral venous blood samples were obtained from each patient. |
| Mean platelet volume(MPV) | change from baseline to after 12 weeks | Peripheral venous blood samples were obtained from each patient. |
| Ankle peak systolic velocity (APSV) | change from baseline to after 12 weeks | is the mean of the peak systolic velocities of the anterior and posterior tibial arteries measured at the ankle level by doppler ultrasonography |
| Arterial diameter | change from baseline to after 12 weeks | Diameter of lower limb arteries measured by doppler ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Actual claudication distance | change from baseline to after 12 weeks | Claudication pain distance was measured after running on a treadmill constant walking speed of 2 mile/hour at 0% grade, with gradual increases in grade of 2.0% every 2 minutes. |
Countries
Egypt
Outcome results
None listed