NCT04734600

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 28, 2021

Last Update Submit

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

EXPERIMENTAL

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

myofascial release technique

ACTIVE COMPARATOR

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

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

aerobic training program

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

myofascial release technique

Eligibility Criteria

Age45 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Physical Therapy

Cairo, Egypt

Location

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: 27754945BACKGROUND
  • 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.

    PMID: 24177266BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • nisrenn EL-NAHAS, profesor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

farag abdel-moniem ali, professor

CONTACT

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
Model Details: 40 patient having single leg intermittent claudication pain
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

Locations