RIPC on Activity, Fatigue and Gait in MS

NCT ID: NCT03967106

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-19

Study Completion Date

2023-03-31

Brief Summary

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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

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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

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly allocated to either the treatment or sham condition.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Remote Ischaemic preconditioning

Remote IPC (RIPC) intervention daily for six weeks.

Group Type EXPERIMENTAL

Ischaemic Preconditioning

Intervention Type OTHER

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.

Sham

Remote sham intervention daily for six weeks.

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

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.

Interventions

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Ischaemic Preconditioning

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

Sham

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JP Moulton Charitable Foundation

OTHER

Sponsor Role collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Siva Nair, MD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

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Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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STH20727

Identifier Type: -

Identifier Source: org_study_id

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