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Effects of Remote Ischemic Preconditioning on Moderate PVD Patients A Pilot Randomized Control Trial (RIPC-PVD)

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ClinicalTrials.gov Identifier: NCT02273232
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
University College Hospital Galway
Information provided by (Responsible Party):
KHALID AHMED, National University of Ireland, Galway, Ireland

Brief Summary:

Remote ischemic Preconditioning (RIPC) is a phenomena first observed in cardio-thoracic patients in which exposing the limbs for periods of short intermittent ischemia produces protective effect on heart muscle. The concept was applied to many other parts of the body and the results are positive so far.

No human trials on this concept has been conducted in patients with peripheral vascular disease so far but applying the concept for healthy individuals shows vessels dilatation and animal trials shows degree of new vessels formation in addition to reports of symptoms improvement.

The trial candidates will be allocated blindly in 4 groups. All groups will have advice about exercise which is the standard practice now. The first group will have supervised exercise. The second group will in addition to the supervised exercise get the ischemic preconditioning with the blood pressure cuff. The third group will get the ischemic preconditioning and the fourth group will get the standard exercise advice. All candidates will have Magnetic Resonance Image Scan (MRA) for their blood vessels in the beginning of the trial and again at the end.

The effect of the RIPC (Remote ischemic Preconditioning) and exercises on patient symptoms, new vessel formation and other parameters will be recorded


Condition or disease Intervention/treatment Phase
Peripheral Arterial Diseases Other: Remote Ischemic Preconditioning Other: Supervised Exercise Other: Standard Care Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Remote Ischemic Preconditioning on Moderate PVD Patients A Pilot Randomized Control Trial
Study Start Date : January 2015
Actual Primary Completion Date : May 5, 2017
Actual Study Completion Date : May 5, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Supervised Exercise Group
All PVD patients will get the standard advice regarding exercises but this group will have a constructed exercise program under supervision of Dr. Micheál Newell who is qualified Sports and Exercise Scientist with a Doctorate degree in Integrated Biology. This include six minute walk test, Chair Stand Test and symptoms free distance.
Other: Supervised Exercise
constructed extra excessive for peripheral vascular diastase patients

Other: Standard Care
Standard Care for peripheral vascular disease patients including advises regarding exercises

Active Comparator: RIPC and supervised Exercise Group
This group will have structured intermitting periods of induced remote ischaemic preconditioning using standard blood pressure cuffs. The cuff will be applied for 5 minutes alternatively with 5 minutes rest to the total of 4 cycles, which needs 40 minutes per day. The RIPC group will receive an exercise program identical to the first group. The total number of days for each participant will be 28 days.
Other: Remote Ischemic Preconditioning
Blood pressure cuff will be inflated to 200 mmhg for 5 minuets and release for 5 minuets to total of 4 cycles
Other Name: RIPC

Other: Supervised Exercise
constructed extra excessive for peripheral vascular diastase patients

Other: Standard Care
Standard Care for peripheral vascular disease patients including advises regarding exercises

Active Comparator: RIPC with Standard Care Group
The patients in this group will receive standard care advice regarding exercise in addition to RIPC as in the 2nd group.
Other: Remote Ischemic Preconditioning
Blood pressure cuff will be inflated to 200 mmhg for 5 minuets and release for 5 minuets to total of 4 cycles
Other Name: RIPC

Other: Standard Care
Standard Care for peripheral vascular disease patients including advises regarding exercises

Sham Comparator: Control Group (Standard Care)
This group will get the standard advice regarding exercise for PVD patients and all the information available in Out patients clinic settings.
Other: Standard Care
Standard Care for peripheral vascular disease patients including advises regarding exercises




Primary Outcome Measures :
  1. Symptoms free distance [ Time Frame: 30 days ]
    Distance which patient can walk without pain at the beginning and the end of the trial will be compared and compared cross groups

  2. ABI -Ankle-Brachial Index Test [ Time Frame: 30 days ]
    ABI measured at the beginning and the end of the trial comparing pre and post results in all groups will be analysed

  3. 6-minute walk test [ Time Frame: 30 days ]
    The standard Test (american college of rheumatology) results will be measured pre and post trial to evaluate any change in functional exercise capacity

  4. EQ-5D quality of life measures [ Time Frame: 6 months ]
    EQ-5D questionnaire will be used as slandered Quality of life assessment tool post trial for candidates a cross groups - http://www.euroqol.org/


Secondary Outcome Measures :
  1. Effects on BP (Blood Pressure ) [ Time Frame: 30 days ]
    changes in BP before after intervention will be evaluated

  2. % changes in ABI [ Time Frame: 30 days ]
    Ankle-Brachial Index percentage changes will be calculated comparing ABI measurement before and after Trial

  3. Minor amputations [ Time Frame: 30 days ]
    Minor amputations (digits) due to disease will be detailed in percentage among groups

  4. Progress for amputation during trial [ Time Frame: 30 days ]
    Record of Progress for amputation during trial - Amputations in the previous outcome will be excluded

  5. Progression of Rutherford classification [ Time Frame: 30 days ]
    record of claudication distance Progression during trial using Rutherford classification



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Known moderate PVD
  2. New claudication patient with Rutherford stage 2 and Fontaine stage 2a symptoms

Exclusion Criteria:

  1. Known upper limb PVD
  2. Severe cardiac condition
  3. Risk classification for exercise training: class C and above
  4. Severe respiratory condition
  5. Previous history of upper limb deep vein thrombosis
  6. Patients on glibenclamide or nicorandil- May affect RIPC
  7. Raynaud's Disease
  8. Contra indications for MRA
  9. Pregnancy
  10. Previous major limb amputation affect ability to exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273232


Locations
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Ireland
University Collage Hospital Galway
Galway, Co Galway, Ireland
Sponsors and Collaborators
National University of Ireland, Galway, Ireland
University College Hospital Galway
Investigators
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Principal Investigator: Stewart E Walsh, Professor NUIG

Publications of Results:

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Responsible Party: KHALID AHMED, Dr/Mr, National University of Ireland, Galway, Ireland
ClinicalTrials.gov Identifier: NCT02273232    
Other Study ID Numbers: C.A 1154
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Keywords provided by KHALID AHMED, National University of Ireland, Galway, Ireland:
Peripheral Arterial Disease
Peripheral Vascular Disease
Claudication
Remote Ischemic Preconditioning
EQ-5D
Symptoms free distance
ABI
micro vessel formation
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases