Ischemic Preconditioning, Exercise Tolerance and Multiple Sclerosis

January 2, 2024 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Regular physical activity improves aspects such as physical fitness, fatigue, quality of life, gait and also reduces the rate of progression of disability in individuals with Multiple Sclerosis. However, individuals with multiple sclerosis are less physically active than the general population. The determinants of engaging in physical activity for individuals with multiple sclerosis include psychological factors like motivation, self-belief and self-regulatory constructs and physical factors like fatigue, weakness, pain and ataxia.

Ischemic preconditioning is exposure of the body to brief periods of circulatory occlusion and re-perfusion to protect organs against ischemic injury. Recent studies have also shown that ischemic preconditioning also improves exercise performance in healthy participants.

The primary aim and objective of this study is to see whether it is feasible to use Ischemic preconditioning to improve exercise performance in people with Multiple Sclerosis.

The design for the study is a double blind randomized control trial. Forty patients with multiple sclerosis above 18 years of age and who have the ability to walk will be randomized to receive either Ischemic preconditioning or sham intervention. All participants will be identified by MS consultants and nurses from the MS clinic and Neuro Day Case Unit of the Royal Hallamshire Hospital in Sheffield. Participation will involve an additional 2 hours of the patients time.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This project is quantified as a Feasibility study. The design for the study is a double blind randomised control trial. Forty patients with MS above 18 years and who have the ability to walk will be randomised to receive either IPC or sham intervention. Potential candidates will be identified from the MS clinic and Neuro Day Case Unit of the Royal Hallamshire Hospital (RHH) in Sheffield.

All participants will be identified by MS consultants and nurses from MS clinics and from neuroday case unit of Royal Hallamshire Hospital. The patient information sheet will be mailed to the participants deemed suitable for the trial by the treating team. The participants will be given up to two weeks to consider their participation in the trial. Patients wishing to participate will be consented by Dr Siva Nair/Kate Lavender/Dr Ismail, following consent Dr Nair/Kate Lavender/ Dr Ismail will ensure the participants are randomised into the treatment group or the control group using a random number table. The MSc student will act as blinded assessor.

After obtaining consent, the research team will conduct checks against the inclusion criteria to assess whether the participant fulfils the criteria for entry into the study. The participant will then be allocated into one of the two groups using a random number table: Experimental group or the Sham group. Participants will not be told which group they have been randomised to. The researcher will check the participant's blood pressure and heart rate while sitting. Then the researcher will request the participant to walk for six minutes as they normally walk. The researcher will measure the distance covered in 6 minutes and will ask the participant to grade the exertion experienced using Borg's Rating of Perceived Exertion scale. The researcher will again measure the blood pressure and heart rate again.

In the active comparator group The participant will rest in a sitting position for 10 minutes before measuring resting blood pressure. Blood pressure will be measured on the arm. IPC will be administered to the upper arm using cuff inflation pressures of 30mm Hg above the systolic BP using a manual BP. The IPC cycles comprised of three cycles of cuff inflation each lasting 5 min in duration followed by 5-min period of cuff deflation.

Within the sham intervention The participant will rest in a sitting position for 10 min before measuring resting blood pressure. Blood pressure will be measured on the upper arm. Sham intervention will be administered to the right upper limb using a manual BP cuff which will be inflated at a pressure 30mmg Hg below the diastolic blood pressure. The sham cycles comprised of three cycles of cuff inflation each lasting 5 minutes in duration followed by 5-min period of cuff deflation.

The researcher will ask the participant to grade any pain or discomfort experienced during the intervention in a scale of 0 (no pain or discomfort) to 10 (Worst pain or discomfort ever experience).

Ten minutes after the end of the cycle the Researcher will again measure the blood pressure and heart rate. Then the participant will be asked to walk for six minutes with the researcher. The researcher will measure the distance covered in 6 minutes. The researcher will ask the participant to grade the exertion experienced using Rating of Perceived Exertion. The researcher will measure the blood pressure and heart rate again. We anticipate that the patient spend around 2 hours at Royal Hallamshire Hospital for this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of MS as per the McDonald's criteria
  2. Aged 18 or older
  3. Sufficient cognitive ability to give informed consent
  4. Ability to walk for 6 minutes without rest
  5. Resting Systolic BP of less than 170 mmHg

Exclusion Criteria:

  1. Cognitive difficulties in giving consent ad understanding the questionnaire
  2. Inability to walk
  3. Other systemic illness affecting exercise tolerance
  4. Resting systolic BP of 170mmHg or more

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ischaemic Preconditioning Group
The participant will rest in a sitting position for 10 minutes before measuring resting blood pressure. Blood pressure will be measured on the arm. IPC will be administered to the upper arm using cuff inflation pressures of 30mm Hg above the systolic BP using a manual BP. The IPC cycles comprised of three cycles of cuff inflation each lasting 5 min in duration followed by 5-min period of cuff deflation
Other: Ischemic Preconditioning
Ischemic preconditioning (IPC) is an experimental technique for producing resistance to the loss of blood supply, and thus oxygen, to tissues of many types. In the heart, IPC is an intrinsic process whereby repeated short episodes of ischaemia protect the myocardium against a subsequent ischaemic insult
Sham Comparator: Control group
The participant will rest in a sitting position for 10 min before measuring resting blood pressure. Blood pressure will be measured on the upper arm. Sham intervention will be administered to the right upper limb using a manual BP cuff which will be inflated at a pressure 30mmg Hg below the diastolic blood pressure. The sham cycles comprised of three cycles of cuff inflation each lasting 5 minutes in duration followed by 5-min period of cuff deflation
Other: Sham Intervention
Sham intervention will be administered to the right upper limb using a manual BP cuff which will be inflated at a pressure 30mmg Hg below the diastolic blood pressure. The sham cycles comprised of three cycles of cuff inflation each lasting 5 minutes in duration followed by 5-min period of cuff deflation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ability to tolerate Ischaemic Preconditioning (IPC_
Time Frame: One day
Patients will be asked to indicate the tolerability of IPC using a visual analogue scale from 0-10 (0 no symptoms and 10 intolerable symptoms).
One day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived rate of exertion
Time Frame: One day
The participant will be asked to grade the exertion of 6 minutes' walk using this scale. It is a valid and reliable tool for measuring the perceived exertion in people with MS
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Siva Nair, Sheffield Teaching Hospitals NHS FT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STH19739

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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