RIPC on Activity, Fatigue and Gait in MS

NCT03967106 | Completed

• 1 other identifier: STH20727
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

remote ischaemic preconditioning; gait analysis; activity; fatigue

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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).

  6 weeks

Study Arms (2)

Remote Ischaemic preconditioning

EXPERIMENTAL

Remote IPC (RIPC) intervention daily for six weeks.

Other: Ischaemic Preconditioning

Sham

SHAM COMPARATOR

Remote sham intervention daily for six weeks.

Other: Sham

Interventions

Ischaemic Preconditioning 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.

Remote Ischaemic preconditioning

Sham 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.

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• JP Moulton Charitable Foundation: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity; Fatigue

Interventions

Ischemic Preconditioning; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Siva Nair, MD

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated to either the treatment or sham condition.

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 30, 2019
• Study Start: August 19, 2019
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

GB (1)