Correlation Between Selected Haematological and Doppler Ultrasonic Parameters in Peripheral Arterial Diseased Patients

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT04830254
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2021-01-20
• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-05
• Primary Completion: 2021-05-12
• Study Completion: 2021-05-20
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
Red cell distribution width (RDW)	change from baseline to after 12 weeks	Peripheral venous blood samples were obtained from each patient.
Arterial diameter	change from baseline to after 12 weeks	Diameter of lower limb arteries measured by doppler ultrasonography

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Cairo, Egypt