Multiple SclerosisNCT03153553
Ischemic Preconditioning, Exercise Tolerance and Multiple Sclerosis
A study testing Ischemic Preconditioning in people with Multiple Sclerosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ischemic Preconditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Apr 2017to 31 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MS as per the McDonald's criteria
- Aged 18 or older
- Sufficient cognitive ability to give informed consent
- Ability to walk for 6 minutes without rest
- Resting Systolic BP of less than 170 mmHg
Who cannot join
- Cognitive difficulties in giving consent ad understanding the questionnaire
- Inability to walk
- Other systemic illness affecting exercise tolerance
- Resting systolic BP of 170mmHg or more
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Ischemic Preconditioning, Sham Intervention
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic PreconditioningOther
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 InterventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Ischaemic Preconditioning Group | Active comparator | 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 Receives: Other: Ischemic Preconditioning |
| Control group | Sham comparator | 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 Receives: Other: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to tolerate Ischaemic Preconditioning (IPC_
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).
Measured: One day
Secondary outcomes (1)
Perceived rate of exertion
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
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start5 Apr 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siva Nair, Principal investigator, Sheffield Teaching Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153553
- Sponsor's protocol ID
- STH19739
- Status last verified
- Jan 2024
- First submitted
- 12 May 2017
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Publications
Chotiyarnwong C, Nair K, Angelini L, Buckley E, Mazza C, Heyes D, Ramiz R, Baster K, Ismail A, Das J, Ali A, Lindert R, Sharrack B, Price S, Paling D. Effect of remote ischaemic preconditioning on walking in people with multiple sclerosis: double-blind randomised controlled trial. BMJ Neurol Open. 2020 Mar 23;2(1):e000022. doi: 10.1136/bmjno-2019-000022. eCollection 2020.
PubMed 33681776
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Preconditioning, Exercise Tolerance and Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03153553
- Acronym / sponsor ID
- STH19739
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 May 2017 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischaemic Preconditioning Group | Active comparator | Other: Ischemic PreconditioningThe 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 |
| Control group | Sham comparator | Other: Sham InterventionThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of MS as per the McDonald's criteria
- Aged 18 or older
- Sufficient cognitive ability to give informed consent
- Ability to walk for 6 minutes without rest
- Resting Systolic BP of less than 170 mmHg
Key exclusion criteria (4 listed)
- Cognitive difficulties in giving consent ad understanding the questionnaire
- Inability to walk
- Other systemic illness affecting exercise tolerance
- Resting systolic BP of 170mmHg or more
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 |
|---|---|---|
| Ischemic PreconditioningIschemic 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 | Other | Ischaemic Preconditioning Group |
| Sham InterventionSham 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 | Control group |
Primary outcome
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).
1 secondary outcome
Perceived rate of exertion
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 33681776Chotiyarnwong C, Nair K, Angelini L, Buckley E, Mazza C, Heyes D, Ramiz R, Baster K, Ismail A, Das J, Ali A, Lindert R, Sharrack B, Price S, Paling D. Effect of remote ischaemic preconditioning on walking in people with multiple sclerosis: double-blind randomised controlled trial. BMJ Neurol Open. 2020 Mar 23;2(1):e000022. doi: 10.1136/bmjno-2019-000022. eCollection 2020.
- Individual participant dataSharing planned: No. no plan to share IPD
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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.
Siva Nair principal investigator
Sheffield Teaching Hospitals NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic Preconditioning in people with Multiple Sclerosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 3 Jan 2024. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to tolerate Ischaemic Preconditioning (IPC_ (time frame: One day). 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 NCT03153553, which also lists 1 linked publication.
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 3 Jan 2024.