EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS
1 other identifier
interventional
40
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2021
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedFirst Posted
Study publicly available on registry
February 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedFebruary 2, 2021
January 1, 2021
2 months
January 28, 2021
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Ankle brachial pressure index ( ABPI )
it will measure by stethoscope and doppler
8 weeks
amount of blood flow velocity
it will be measured by doppler ultrasound
8 weeks
Secondary Outcomes (2)
claudication onset time (COT) or distance
8 weeks
a peak walking time (PWT) or peak walking distance.
8 weeks
Study Arms (2)
aerobic training program
EXPERIMENTALgroup a:twenty patients who will receive aerobic training program combine with traditional burger exercises for 45 mints, 3 times per week for two months as a total treatment period in addition to their medical treatment.
myofascial release technique
ACTIVE COMPARATORgroup B: twenty patients who will receive myofascial release technique combine with traditional burger exercises for 45 mints, 3 times per week for two months as a total treatment period in addition to their medical treatment.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- \. 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
- Age was ranged from 45 -55years.
- Patients who have intermittent claudicating pain during activities not at rest.
- BMI between 25-29.9 kg
You may not qualify if:
- patients who was not willing to participate in the study.
- patients who have severe foot ulcer, and who were diagnosed as Peripheral arterial insufficiency grade III, IV.
- patients who have the ABI is less than 0.50
- Patients who have past history of (unstable cardiovascular diseases, marked dyspnea on exertion or with chronic obstructive pulmonary diseases (COPD), liver and kidney diseases).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ola mohamed elsayed mostafa elgoharylead
- Cairo Universitycollaborator
Study Sites (1)
Physical Therapy
Cairo, Egypt
Related Publications (2)
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.
PMID: 27754945BACKGROUNDPrevost 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.
PMID: 24177266BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
nisrenn EL-NAHAS, profesor
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS
Study Record Dates
First Submitted
January 28, 2021
First Posted
February 2, 2021
Study Start
February 1, 2021
Primary Completion
April 15, 2021
Study Completion
May 1, 2021
Last Updated
February 2, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share