Multiple SclerosisMSIPC-2NCT03967106
RIPC on Activity, Fatigue and Gait in MS
A study testing Ischaemic Preconditioning in people with Multiple Sclerosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study evaluates whether Remote Ischaemic Preconditioning (RIPC) can improve activity, gait and fatigue in people with Multiple Sclerosis. Half the participants will receive RIPC, the other half will receive a sham treatment. 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?
- Ischaemic Preconditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Aug 2019to 31 Mar 2023
- 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
- Sufficient cognitive ability and understanding of the English language to give informed consent and complete study questionnaires
- Ability to walk for 6 minutes without rest
- Resting Systolic BP of more than 100mmHg
- Resting Systolic BP of less than 170mmHg
Who cannot join
- Cognitive difficulties or insufficient English to allow understanding of consent and study questionnaires
- Inability to walk
- Other systemic illness affecting exercise tolerance
- Resting Systolic BP of less than 100mmHg
- Resting systolic BP of 170mmHg or more
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: Role of Remote Ischaemic Preconditioning on Activity, Fatigue and Gait in People With Multiple Sclerosis.
This study evaluates whether Remote Ischaemic Preconditioning (RIPC) can improve activity, gait and fatigue in people with Multiple Sclerosis. Half the participants will receive RIPC, the other half will receive a sham treatment.
Read the detailed description
Regular physical activity has been shown to improve physical fitness, fatigue, quality of life, and reduce the progression of disability in people with multiple sclerosis (MS). However, people with MS are less physically active than others. This is partly due to poor exercise tolerance and fatigue.
Remote Ischemic preconditioning (RIPC) is the exposure of a limb to brief periods of circulatory occlusion and reperfusion by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg), to protect organs against ischaemic injury. RIPC has been shown to improve exercise performance and delay fatigue in athletes. However, there is little to no research examining the effect of RIPC on walking or exercise performance in MS patients. The aim of this trial is to assess whether RIPC can improve activity, gait and reduce fatigue in people with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Ischaemic Preconditioning, Sham
- Keywords
- remote ischaemic preconditioning, gait analysis, activity, fatigue
- Medical subject headings
- Multiple Sclerosis, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischaemic PreconditioningOther
IPC to the upper arm using a manual blood pressure machine with cuff. Three cycles of 5 minute cuff inflation to 30mmHg above the systolic blood pressure (BP) followed by 5 minute cuff deflation.
ShamOther
Sham intervention to the upper arm using a manual blood pressure machine with cuff. Three cycles of 5 minute cuff inflation to 30mmHg below the diastolic blood pressure (BP) followed by 5 minute cuff deflation.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischaemic preconditioning | Experimental | Remote IPC (RIPC) intervention daily for six weeks. Receives: Other: Ischaemic Preconditioning |
| Sham | Sham comparator | Remote sham intervention daily for six weeks. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in speed of walking over a one week period
Change in activity levels will be assessed by measuring the average speed of participants walking during the waking hours over a one week period, using a wearable activity monitor for one week before the intervention and during the final week of the 6 week intervention period.
Measured: 7 weeks
Change from baseline in number of steps taken over a one week period
Change in activity levels will be assessed by measuring the average number of steps taken during the waking hours over a one week period, using a wearable activity monitor for one week before the intervention and during the final week of the 6 week intervention period.
Measured: 7 weeks
Change from baseline in length of stride over a one week period
Change in activity levels will be assessed by measuring the average length of stride during the waking hours over a one week period, using a wearable activity monitor for one week before the intervention and during the final week of the 6 week intervention period.
Measured: 7 weeks
Change from baseline in speed of walking during the 6 minute walk test
Speed of walking during the 6 minute walk test will be assessed using wearable sensors at baseline and after the 6 week intervention period. The 6 minute walk test assesses exercise tolerance by assessing walking over the span of six minute.
Measured: 6 weeks
Change from baseline in Modified Fatigue Impact Scale (MFIS) Score
A 21 item self reported fatigue scale which assess the effects of fatigue across three domains, cognitive, physical and psycho-social. Each item is scored from 0-4 (0=no effect of fatigue, 4=large effect of fatigue) yielding a total between 0 - 84.
Measured: 6 weeks
Change from baseline in Multiple Sclerosis Walking Scale 12 (MSWS-12) score
A 12 item self reported scale which assesses the impact of MS on a patient's walking ability. Each item is scored from 1-5 (1=no impact, 5=high impact), yielding a total between 1-60 which is transformed to a percentage out of 100.
Measured: 6 weeks
Change from baseline in Borgs rating of perceived exertion scale score
Exertion after the 6 minute walk test will be measured at baseline and following the 6 week intervention period using the Borgs rating of perceived exertion scale, a self report measure of perceived exertion ranging from 6-20 (6=no exertion, 20=exhaustion).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start19 Aug 2019
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to either the treatment or sham condition.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- JP Moulton Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Siva Nair, MD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967106
- Sponsor's protocol ID
- STH20727
- Acronym
- MSIPC-2
- Status last verified
- Jan 2024
- First submitted
- 28 May 2019
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Remote Ischaemic Preconditioning on Activity, Fatigue and Gait in People With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT03967106
- Acronym / sponsor ID
- MSIPC-2 / STH20727
- Conditions
- Multiple Sclerosis
- Keywords
- remote ischaemic preconditioning, gait analysis, activity, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- JP Moulton Charitable Foundation
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 30 May 2019 (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 evaluates whether Remote Ischaemic Preconditioning (RIPC) can improve activity, gait and fatigue in people with Multiple Sclerosis. Half the participants will receive RIPC, the other half will receive a sham treatment.
Detailed description
Regular physical activity has been shown to improve physical fitness, fatigue, quality of life, and reduce the progression of disability in people with multiple sclerosis (MS). However, people with MS are less physically active than others. This is partly due to poor exercise tolerance and fatigue.
Remote Ischemic preconditioning (RIPC) is the exposure of a limb to brief periods of circulatory occlusion and reperfusion by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg), to protect organs against ischaemic injury. RIPC has been shown to improve exercise performance and delay fatigue in athletes. However, there is little to no research examining the effect of RIPC on walking or exercise performance in MS patients. The aim of this trial is to assess whether RIPC can improve activity, gait and reduce fatigue in people with MS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to either the treatment or sham condition.
| Arm | Type | Receives |
|---|---|---|
| Remote Ischaemic preconditioning | Experimental | Other: Ischaemic PreconditioningRemote IPC (RIPC) intervention daily for six weeks. |
| Sham | Sham comparator | Other: ShamRemote sham intervention daily for six weeks. |
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
- Sufficient cognitive ability and understanding of the English language to give informed consent and complete study questionnaires
- Ability to walk for 6 minutes without rest
- Resting Systolic BP of more than 100mmHg
- Resting Systolic BP of less than 170mmHg
Key exclusion criteria (5 listed)
- Cognitive difficulties or insufficient English to allow understanding of consent and study questionnaires
- Inability to walk
- Other systemic illness affecting exercise tolerance
- Resting Systolic BP of less than 100mmHg
- 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 |
|---|---|---|
| Ischaemic PreconditioningIPC to the upper arm using a manual blood pressure machine with cuff. Three cycles of 5 minute cuff inflation to 30mmHg above the systolic blood pressure (BP) followed by 5 minute cuff deflation. | Other | Remote Ischaemic preconditioning |
| ShamSham intervention to the upper arm using a manual blood pressure machine with cuff. Three cycles of 5 minute cuff inflation to 30mmHg below the diastolic blood pressure (BP) followed by 5 minute cuff deflation. | Other | Sham |
Primary outcome
Change from baseline in speed of walking over a one week period
Time frame: 7 weeks
Change in activity levels will be assessed by measuring the average speed of participants walking during the waking hours over a one week period, using a wearable activity monitor for one week before the intervention and during the final week of the 6 week intervention period.
Change from baseline in number of steps taken over a one week period
Time frame: 7 weeks
Change in activity levels will be assessed by measuring the average number of steps taken during the waking hours over a one week period, using a wearable activity monitor for one week before the intervention and during the final week of the 6 week intervention period.
Change from baseline in length of stride over a one week period
Time frame: 7 weeks
Change in activity levels will be assessed by measuring the average length of stride during the waking hours over a one week period, using a wearable activity monitor for one week before the intervention and during the final week of the 6 week intervention period.
Change from baseline in speed of walking during the 6 minute walk test
Time frame: 6 weeks
Speed of walking during the 6 minute walk test will be assessed using wearable sensors at baseline and after the 6 week intervention period. The 6 minute walk test assesses exercise tolerance by assessing walking over the span of six minute.
Change from baseline in Modified Fatigue Impact Scale (MFIS) Score
Time frame: 6 weeks
A 21 item self reported fatigue scale which assess the effects of fatigue across three domains, cognitive, physical and psycho-social. Each item is scored from 0-4 (0=no effect of fatigue, 4=large effect of fatigue) yielding a total between 0 - 84.
Change from baseline in Multiple Sclerosis Walking Scale 12 (MSWS-12) score
Time frame: 6 weeks
A 12 item self reported scale which assesses the impact of MS on a patient's walking ability. Each item is scored from 1-5 (1=no impact, 5=high impact), yielding a total between 1-60 which is transformed to a percentage out of 100.
Change from baseline in Borgs rating of perceived exertion scale score
Time frame: 6 weeks
Exertion after the 6 minute walk test will be measured at baseline and following the 6 week intervention period using the Borgs rating of perceived exertion scale, a self report measure of perceived exertion ranging from 6-20 (6=no exertion, 20=exhaustion).
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 5 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
Recruiting
HOBSCOTCH-MS-Efficacy Trial
Multiple Sclerosis, Cognitive Dysfunction
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
RecruitingObservational study
Aerobic Fitness in Multiple Sclerosis: The Relationship Between Balance and Sensory Dual-Tasking
Multiple Sclerosis
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
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, MD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischaemic 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 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: finished, as of the sponsor's last update on 5 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?
Change from baseline in speed of walking over a one week period (time frame: 7 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024; AzTrials last refreshed its copy on 3 Nov 2026.