EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS

Peripheral Arterial Disease Clinical Trial

Official title:

EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04734600
• Other study ID #: aeobic training,MFR and PAD
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 2021

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: ola elgohary
• Phone: 01227191398
• Email: ola_elgoharyy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 55 Years

Eligibility

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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Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Electronic Treadmill device
group A:PN-7001M Panasonic Treadmill 130 kg, frequency 50 HZ, input voltage AC220 V, input power 100W+_ 10 will usefor aerobic training program ,start by 1pbm grading to 2pbm speed and increase according to patient abilities during sessions ,0% treadmill inclination angle for two month as a total treatment period for study group patients. Patients in this group will participate in aerobic training as march walking on treadmill for 45 mints duration for session 3 times per week, start with 5 mints warm up beginning and 5 mints cooling down at end session, in addition to their medical program and burger exercises

Other:
• myofascial release technique
group B:The myofascial release technique group will receive a 45 mints session time, for3 times per week for two months in addition to their medical program and burger exercises. Before the MF will starte, patient will rested in a relaxed prone position for 15 to 30 mints and also after end session time, MF protocol will applied as follow sequence over all period of total treatment sessions (8) week.: thoracolumbar cross hand facial release technique for at least 5 mints for every barrier depth area, started by one hand will place on high thoracic area with pressure applied cephalic, the other hand was placed directly on the lower lumbo -sacrum area pushing caudal and arms are crossed to maximize as leverage as the barrier sense of softening will occurre and release sense on fascia under hand (release done at transverse alternative with longitudinal direction)alternation same methods to affected leg

Locations

Country	Name	City	State
Egypt	Physical Therapy	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
ola mohamed elsayed mostafa elgohary	Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

McDermott MM, Polonsky TS. Home-Based Exercise: A Therapeutic Option for Peripheral Artery Disease. Circulation. 2016 Oct 18;134(16):1127-1129. Review. — View Citation

Prévost 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle brachial pressure index ( ABPI )	it will measure by stethoscope and doppler	8 weeks
Primary	amount of blood flow velocity	it will be measured by doppler ultrasound	8 weeks
Secondary	claudication onset time (COT) or distance	it will be measured by Graded Treadmill Exercise Testing	8 weeks
Secondary	a peak walking time (PWT) or peak walking distance.	it will be measured by Graded Treadmill Exercise Testing	8 weeks