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

Sponsor
ola mohamed elsayed mostafa elgohary (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04734600
Collaborator
Cairo University (Other)
40
1
2
2.9
13.7

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Device: Electronic Treadmill device
  • Other: myofascial release technique
N/A

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 .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
40 patient having single leg intermittent claudication pain40 patient having single leg intermittent claudication pain
Masking:
Single (Participant)
Masking Description:
AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS
Primary Purpose:
Treatment
Official Title:
EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Apr 15, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: aerobic training program

group 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.

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

Active Comparator: myofascial release technique

group 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.

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

Outcome Measures

Primary Outcome Measures

  1. Ankle brachial pressure index ( ABPI ) [8 weeks]

    it will measure by stethoscope and doppler

  2. amount of blood flow velocity [8 weeks]

    it will be measured by doppler ultrasound

Secondary Outcome Measures

  1. claudication onset time (COT) or distance [8 weeks]

    it will be measured by Graded Treadmill Exercise Testing

  2. a peak walking time (PWT) or peak walking distance. [8 weeks]

    it will be measured by Graded Treadmill Exercise Testing

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

  2. Age was ranged from 45 -55years.

  3. Patients who have intermittent claudicating pain during activities not at rest.

  4. BMI between 25-29.9 kg

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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Physical Therapy Cairo Egypt

Sponsors and Collaborators

  • ola mohamed elsayed mostafa elgohary
  • Cairo University

Investigators

  • Study Director: nisrenn EL-NAHAS, profesor, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ola mohamed elsayed mostafa elgohary, EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS, Cairo University
ClinicalTrials.gov Identifier:
NCT04734600
Other Study ID Numbers:
  • aeobic training,MFR and PAD
First Posted:
Feb 2, 2021
Last Update Posted:
Feb 2, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2021