RIPC on Activity, Fatigue and Gait in MS (MSIPC-2)
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ischaemic Preconditioning
Sham
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis focused on measuring remote ischaemic preconditioning, gait analysis, activity, fatigue
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Sheffield Teaching Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Remote Ischaemic preconditioning
Sham
Arm Description
Remote IPC (RIPC) intervention daily for six weeks.
Remote sham intervention daily for six weeks.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03967106
First Posted
May 28, 2019
Last Updated
May 28, 2019
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
JP Moulton Charitable Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03967106
Brief Title
RIPC on Activity, Fatigue and Gait in MS
Acronym
MSIPC-2
Official Title
Role of Remote Ischaemic Preconditioning on Activity, Fatigue and Gait in People With Multiple Sclerosis.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
JP Moulton Charitable Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
remote ischaemic preconditioning, gait analysis, activity, fatigue
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly allocated to either the treatment or sham condition.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remote Ischaemic preconditioning
Arm Type
Experimental
Arm Description
Remote IPC (RIPC) intervention daily for six weeks.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Remote sham intervention daily for six weeks.
Intervention Type
Other
Intervention Name(s)
Ischaemic Preconditioning
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in speed of walking over a one week period
Description
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.
Time Frame
7 weeks
Title
Change from baseline in number of steps taken over a one week period
Description
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.
Time Frame
7 weeks
Title
Change from baseline in length of stride over a one week period
Description
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.
Time Frame
7 weeks
Title
Change from baseline in speed of walking during the 6 minute walk test
Description
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.
Time Frame
6 weeks
Title
Change from baseline in Modified Fatigue Impact Scale (MFIS) Score
Description
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.
Time Frame
6 weeks
Title
Change from baseline in Multiple Sclerosis Walking Scale 12 (MSWS-12) score
Description
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.
Time Frame
6 weeks
Title
Change from baseline in Borgs rating of perceived exertion scale score
Description
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).
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siva Nair, MD
Phone
0114 2769127
Email
Siva.Nair@sth.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siva Nair, MD
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siva Nair, MBBS/MD
Phone
0114 2712769
Email
siva.nair@sth.nhs.uk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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RIPC on Activity, Fatigue and Gait in MS
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