Peripheral Arterial DiseaseNCT04734600
EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS
A study testing Electronic Treadmill device and myofascial release technique in people with Peripheral Arterial Disease, run by ola mohamed elsayed mostafa elgohary at 1 site in Egypt.
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? Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Electronic Treadmill device and myofascial release technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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).
- -
Trial locations and contacts
1 site in 1 country.
farag abdel-moniem ali, professor contact
Egypt1 site
Physical Therapy
Cairo
FARAG ABD-ELMONEIM ALY, professor, 01005446559
niseen GHAREB EL-NAHAS, pofessor, 0100227242
About this study
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?
Read the 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 .
- Conditions
- Peripheral Arterial Disease
- Being tested
- Electronic Treadmill device, myofascial release technique
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Treadmill deviceDevice
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
myofascial release techniqueOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: myofascial release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle brachial pressure index ( ABPI )
it will measure by stethoscope and doppler
Measured: 8 weeks
amount of blood flow velocity
it will be measured by doppler ultrasound
Measured: 8 weeks
Secondary outcomes (2)
claudication onset time (COT) or distance
it will be measured by Graded Treadmill Exercise Testing
Measured: 8 weeks
a peak walking time (PWT) or peak walking distance.
it will be measured by Graded Treadmill Exercise Testing
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Feb 2021 (estimated)
- Primary completion15 Apr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 40 patient having single leg intermittent claudication pain
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ola mohamed elsayed mostafa elgohary
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, ola mohamed elsayed mostafa elgohary, Cairo University
- Investigators
- nisrenn EL-NAHAS, profesor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734600
- Sponsor's protocol ID
- aeobic training,MFR and PAD
- Status last verified
- Jan 2021
- First submitted
- 28 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27754945Prevost 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.
PubMed 24177266
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS
- ClinicalTrials.gov ID
- NCT04734600
- Acronym / sponsor ID
- aeobic training,MFR and PAD
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ola mohamed elsayed mostafa elgoharyUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 40 patient having single leg intermittent claudication pain
| Arm | Type | Receives |
|---|---|---|
| aerobic training program | Experimental | Device: Electronic Treadmill devicegroup 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 comparator | Other: myofascial release techniquegroup 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. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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).
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Treadmill devicegroup 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 | Device | aerobic training program |
| myofascial release techniquegroup 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 | Other | myofascial release technique |
Primary outcome
Ankle brachial pressure index ( ABPI )
Time frame: 8 weeks
it will measure by stethoscope and doppler
amount of blood flow velocity
Time frame: 8 weeks
it will be measured by doppler ultrasound
2 secondary outcomes
claudication onset time (COT) or distance
Time frame: 8 weeks
a peak walking time (PWT) or peak walking distance.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Background: PubMed 27754945McDermott 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.
- Background: PubMed 24177266Prevost 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
farag abdel-moniem ali, professor contact
nisrenn EL-NAHAS, profesor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Treadmill device and myofascial release technique in people with Peripheral Arterial Disease, run by ola mohamed elsayed mostafa elgohary at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ola elgohary (01227191398, ola_elgoharyy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle brachial pressure index ( ABPI ) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04734600, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.