RIPC on Activity, Fatigue and Gait in MS (MSIPC-2)

NHS Foundation Trust

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Sham; Other: Ischaemic Preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03967106

STH20727

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups

Remote Ischaemic preconditioning

Experimental group

Description:

Remote IPC (RIPC) intervention daily for six weeks.

Treatment:

Other: Ischaemic Preconditioning

Sham

Sham Comparator group

Description:

Remote sham intervention daily for six weeks.

Treatment:

Other: Sham