Back to resultsCorrelation Between Selected Haematological and Doppler Ultrasonic Parameters in Peripheral Arterial Diseased Patients
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transcutaneous Electrical Nerve Stimulation(TENS) device
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
- Unilateral Leriche-Fontaine stage-II PAD
- Both sexes
- Aged 50 to 60 years
- Outpatients
- Clinically stable
- Sedentary
- Not participating in any physical activity last 3 months
Exclusion Criteria:
- Walking disorders related to orthopedic or neuromuscular disease
- Renal insufficiency requiring dialysis (Renal diseases)
- Known and documented myopathy
- Progressive cancer
- Associated progressive disease causing a deterioration in general health
- Participation in another research protocol
- Skin disorder making it impossible to use TENS
- Absolute contraindication to physical activity
- Presence of a pacemaker/defibrillator
Sites / Locations
- Faculty of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
study group(A)
Control group(B)
Arm Description
Group (A) included 20 patients who received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs) for 45 min per session, three times per week, and for 12 weeks.
The control group(B) included 20 patients who received placebo TENS stimulation but with a voltage level falling to zero after 10 s of stimulation
Outcomes
Primary Outcome Measures
Red cell distribution width (RDW)
Peripheral venous blood samples were obtained from each patient.
Mean platelet volume(MPV)
Peripheral venous blood samples were obtained from each patient.
Ankle peak systolic velocity (APSV)
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
Diameter of lower limb arteries measured by doppler ultrasonography
Secondary Outcome Measures
Actual claudication distance
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04830254
Brief Title
Correlation Between Selected Haematological and Doppler Ultrasonic Parameters in Peripheral Arterial Diseased Patients
Official Title
Correlation Between Selected Hematological and Doppler Ultrasonic Parameters After Electrical Stimulation in Peripheral Arterial Diseased Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
May 12, 2021 (Actual)
Study Completion Date
May 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group(A)
Arm Type
Active Comparator
Arm Description
Group (A) included 20 patients who received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs) for 45 min per session, three times per week, and for 12 weeks.
Arm Title
Control group(B)
Arm Type
Sham Comparator
Arm Description
The control group(B) included 20 patients who received placebo TENS stimulation but with a voltage level falling to zero after 10 s of stimulation
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation(TENS) device
Other Intervention Name(s)
TENS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Red cell distribution width (RDW)
Description
Peripheral venous blood samples were obtained from each patient.
Time Frame
change from baseline to after 12 weeks
Title
Mean platelet volume(MPV)
Description
Peripheral venous blood samples were obtained from each patient.
Time Frame
change from baseline to after 12 weeks
Title
Ankle peak systolic velocity (APSV)
Description
is the mean of the peak systolic velocities of the anterior and posterior tibial arteries measured at the ankle level by doppler ultrasonography
Time Frame
change from baseline to after 12 weeks
Title
Arterial diameter
Description
Diameter of lower limb arteries measured by doppler ultrasonography
Time Frame
change from baseline to after 12 weeks
Secondary Outcome Measure Information:
Title
Actual claudication distance
Description
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.
Time Frame
change from baseline to after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral Leriche-Fontaine stage-II PAD
Both sexes
Aged 50 to 60 years
Outpatients
Clinically stable
Sedentary
Not participating in any physical activity last 3 months
Exclusion Criteria:
Walking disorders related to orthopedic or neuromuscular disease
Renal insufficiency requiring dialysis (Renal diseases)
Known and documented myopathy
Progressive cancer
Associated progressive disease causing a deterioration in general health
Participation in another research protocol
Skin disorder making it impossible to use TENS
Absolute contraindication to physical activity
Presence of a pacemaker/defibrillator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
ZIP/Postal Code
12316
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Correlation Between Selected Haematological and Doppler Ultrasonic Parameters in Peripheral Arterial Diseased Patients
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