Clinical trial NCT04734600: EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS
Official title: EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2021-02-02
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 40 patient having single leg intermittent claudication pain
Primary purpose: TREATMENT

Brief summary: This study is trying to answer the following research question: "Are there any differences between effects of aerobic training and myofascial release on claudication among peripheral arterial insuffiency patients?

Detailed description: Peripheral arterial disease is a systemic disorder and for the most part progressive. The condition is associated with life and limb-threatening complications. Symptoms of PAD range from intermittent claudication-defined as fatigue or discomfort in calf, buttock, or thigh muscles on exertion that is relieved by rest-to critical limb ischemia-defined as distal leg pain at rest with or without ischemic ulcers Despite many advances in endovascular surgery, amputations of digits and limbs are not uncommon. Thus, the present-day approach is to prevent the disorder in the first place. There are many evidences that support changes in lifestyle can significantly decrease the rate of progression of the disease and improve the quality of life in addition to aerobic training exercise and manual therapy .

Eligibility criteria: Inclusion Criteria:The patients had been met the following criteria to be involved in this study:

1. Patients from both sexes who were medically diagnosed as peripheral arterial insufficiency with type II claudication at single lower limb 2- Peripheral arterial insufficiency patients, who have ABI inbetween0.90-0.50

1. Age was ranged from 45 -55years.
2. Patients who have intermittent claudicating pain during activities not at rest.
3. BMI between 25-29.9 kg

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Exclusion Criteria:

1. patients who was not willing to participate in the study.
2. patients who have severe foot ulcer, and who were diagnosed as Peripheral arterial insufficiency grade III, IV.
3. patients who have the ABI is less than 0.50
4. Patients who have past history of (unstable cardiovascular diseases, marked dyspnea on exertion or with chronic obstructive pulmonary diseases (COPD), liver and kidney diseases).

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Primary outcomes:
measure: Ankle brachial pressure index ( ABPI )
timeFrame: 8 weeks
measure: amount of blood flow velocity
timeFrame: 8 weeks
Secondary outcomes:
measure: claudication onset time (COT) or distance
timeFrame: 8 weeks
measure: a peak walking time (PWT) or peak walking distance.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Physical Therapy
Study officials:
affiliation: Cairo University
name: nisrenn EL-NAHAS, profesor
role: STUDY_DIRECTOR
References:
citation: McDermott MM, Polonsky TS. Home-Based Exercise: A Therapeutic Option for Peripheral Artery Disease. Circulation. 2016 Oct 18;134(16):1127-1129. doi: 10.1161/CIRCULATIONAHA.116.023691. No abstract available.
citation: Prevost A, Lafitte M, Pucheu Y, Couffinhal T; on behalf the CEPTA educational team. Education and home based training for intermittent claudication: functional effects and quality of life. Eur J Prev Cardiol. 2015 Mar;22(3):373-9. doi: 10.1177/2047487313512217. Epub 2013 Oct 31.