Treadmill with TENS on Functional Capacity &muscle Oxygenation in PAD Patients
Key facts
- Who runs it
- Cairo University
- Where
- Egypt1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 50 people enrolled
- Started
- 1 Oct 2023
- Ended
- 30 Nov 2024
- Type of study
- Interventional, 2 groups
- Treatments tested
- TREADMILL(SIDEA-Germany treadmill ) with TENS
- Record updated
- 12 December 2024
Who can take part
- Age
- 40 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- • Fifty patients who had intermittent claudication secondary to PAD; Ambulation during a graded treadmill test limited by leg pain consistent with intermittent claudication (stage II of the Fontaine classification of PAD); Ankle-brachial index (ABI) of 0.90 or lower at rest or 0.73 or lower after exercise; Their age will be ranged from 40-75 years old; Body mass index (BMI) from 18.5 to 40 kg/m2; they are able to take part in an outpatient rehabilitation program; they are clinically stable; they are sedentary activity level according to Global Physical Activity Questionnaire (GPAQ); smokers
Who cannot take part
- • Absence of PAD; Inability to obtain an ABI measure because of non compressible vessels; Asymptomatic PAD determined from the medical history and verified during the graded treadmill test; Use of cilostazol and pentoxifylline initiated within 3 months before the investigation; Exercise tolerance limited by factors other than leg pain; Active cancer, renal disease, or liver disease; The presence of a contraindication to the use of TENS, such as a pacemaker or skin lesion; walking disorders related to orthopedic or neuromuscular disease; myopathy; associated progressive disease causing deterioration in general health; implanted pacemaker or defibrillator; uncontrolled diabetes
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Fifty patients from both sexes with PAD, stage II fontaine will participate in this study. Their ages will be from 40-75 years old. They will be selected from kasr el ainy (faculty of medicine), Cairo University, Giza, Egypt. The patients will be randomly assigned into two equal groups:
Read full original descriptionShow less
Group (A): 25 patients will receive transcutaneous electrical nerve stimulation (TENS) for 45 minutes per session applied on calf muscle, combined with treadmill three days per week for twelve weeks in addition to the routine medical treatment.
Group (B): 25 patients will receive treadmill training for 45 minutes per session, three days per week for twelve weeks in addition to the routine medical treatment
The 2 groups in the trial
- Treadmill with TENS trainingTreatment being tested
SIDEA-Germany treadmill \& MH8001 Portable tens Treadmill walking initially will begin exercising at 2 mph (3.2 km/h) at a 0% grade. They will walk until their claudication pain and determine site of pain then we will apply TENS on pain site and starting frequency at 2 HZ, then will increase inclination of treadmill gradually together with increasing frequancy of TENS up to 120 HZ if patient will report any feeling of pain, pain became moderately severe (4 of 5 on the claudication scale), throughout 45-minute exercise session. When a participant will be able to walk for 8 minutes at the initial workload without having to stop because of moderately severe claudication, the treadmill grade will be increased by increments of 0.5% until an 8-10% grade will be achieved. Subsequently, exercise intensity will be increased during training sessions by increasing the treadmill speed by increments of 0.1-0.2 mph (0.2-0.3 km/h) as tolerated
Treatment: TREADMILL(SIDEA-Germany treadmill ) with TENS
- Treadmill trainingOther group
Over the past 30 years, treadmill-based SET programs have been shown to be consistently beneficial in improving walking ability as assessed by graded treadmill testing and to be effective in patients with PAD both with and without classic symptoms of claudication. Treadmill-based exercise therapy for patients with PAD consists of intermittent bouts of walking exercise to moderate to moderately severe discomfort (4 of 5 on the claudication scale) followed by short periods of rest until symptoms resolve. These exercise/rest bouts are repeated over a 30- to 45-minute exercise session. Exercise capability is most commonly measured as COT/COD and PWT/PWD.
Treatment: TREADMILL(SIDEA-Germany treadmill ) with TENS
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Treadmill Training with TENS Impact on Walking Distance, Pain and Peak Velocity in Patients with Peripheral Arterial Disease
- Record updated
- 12 December 2024