Clinical trial NCT03967106: RIPC on Activity, Fatigue and Gait in MS
Official title: Role of Remote Ischaemic Preconditioning on Activity, Fatigue and Gait in People With Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: remote ischaemic preconditioning
gait analysis
activity
fatigue
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: JP Moulton Charitable Foundation
First posted: 2019-05-30
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to either the treatment or sham condition.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline in speed of walking over a one week period
timeFrame: 7 weeks
measure: Change from baseline in number of steps taken over a one week period
timeFrame: 7 weeks
measure: Change from baseline in length of stride over a one week period
timeFrame: 7 weeks
measure: Change from baseline in speed of walking during the 6 minute walk test
timeFrame: 6 weeks
measure: Change from baseline in Modified Fatigue Impact Scale (MFIS) Score
timeFrame: 6 weeks
measure: Change from baseline in Multiple Sclerosis Walking Scale 12 (MSWS-12) score
timeFrame: 6 weeks
measure: Change from baseline in Borgs rating of perceived exertion scale score
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Siva Nair, MD
role: PRINCIPAL_INVESTIGATOR
References: