Ischemic Preconditioning, Exercise Tolerance and Multiple Sclerosis

NCT03153553 | Completed DMC

• 1 other identifier: STH19739
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Regular physical activity improves aspects such as physical fitness, fatigue, quality of life, gait and also reduces the rate of progression of disability in individuals with Multiple Sclerosis. However, individuals with multiple sclerosis are less physically active than the general population. The determinants of engaging in physical activity for individuals with multiple sclerosis include psychological factors like motivation, self-belief and self-regulatory constructs and physical factors like fatigue, weakness, pain and ataxia. Ischemic preconditioning is exposure of the body to brief periods of circulatory occlusion and re-perfusion to protect organs against ischemic injury. Recent studies have also shown that ischemic preconditioning also improves exercise performance in healthy participants. The primary aim and objective of this study is to see whether it is feasible to use Ischemic preconditioning to improve exercise performance in people with Multiple Sclerosis. The design for the study is a double blind randomized control trial. Forty patients with multiple sclerosis above 18 years of age and who have the ability to walk will be randomized to receive either Ischemic preconditioning or sham intervention. All participants will be identified by MS consultants and nurses from the MS clinic and Neuro Day Case Unit of the Royal Hallamshire Hospital in Sheffield. Participation will involve an additional 2 hours of the patients time.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Ability to tolerate Ischaemic Preconditioning (IPC_

  Patients will be asked to indicate the tolerability of IPC using a visual analogue scale from 0-10 (0 no symptoms and 10 intolerable symptoms).

  One day

Secondary Outcomes (1)

• Perceived rate of exertion

  One day

Study Arms (2)

Ischaemic Preconditioning Group

ACTIVE COMPARATOR

The participant will rest in a sitting position for 10 minutes before measuring resting blood pressure. Blood pressure will be measured on the arm. IPC will be administered to the upper arm using cuff inflation pressures of 30mm Hg above the systolic BP using a manual BP. The IPC cycles comprised of three cycles of cuff inflation each lasting 5 min in duration followed by 5-min period of cuff deflation

Other: Ischemic Preconditioning

Control group

SHAM COMPARATOR

The participant will rest in a sitting position for 10 min before measuring resting blood pressure. Blood pressure will be measured on the upper arm. Sham intervention will be administered to the right upper limb using a manual BP cuff which will be inflated at a pressure 30mmg Hg below the diastolic blood pressure. The sham cycles comprised of three cycles of cuff inflation each lasting 5 minutes in duration followed by 5-min period of cuff deflation

Other: Sham Intervention

Interventions

Ischemic Preconditioning OTHER

Ischemic preconditioning (IPC) is an experimental technique for producing resistance to the loss of blood supply, and thus oxygen, to tissues of many types. In the heart, IPC is an intrinsic process whereby repeated short episodes of ischaemia protect the myocardium against a subsequent ischaemic insult

Ischaemic Preconditioning Group

Sham Intervention OTHER

Sham intervention will be administered to the right upper limb using a manual BP cuff which will be inflated at a pressure 30mmg Hg below the diastolic blood pressure. The sham cycles comprised of three cycles of cuff inflation each lasting 5 minutes in duration followed by 5-min period of cuff deflation

Control group

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
• Aged 18 or older
• Sufficient cognitive ability to give informed consent
• Ability to walk for 6 minutes without rest
• Resting Systolic BP of less than 170 mmHg

You may not qualify if:

• Cognitive difficulties in giving consent ad understanding the questionnaire
• Inability to walk
• Other systemic illness affecting exercise tolerance
• Resting systolic BP of 170mmHg or more

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Related Publications (1)

• Chotiyarnwong C, Nair K, Angelini L, Buckley E, Mazza C, Heyes D, Ramiz R, Baster K, Ismail A, Das J, Ali A, Lindert R, Sharrack B, Price S, Paling D. Effect of remote ischaemic preconditioning on walking in people with multiple sclerosis: double-blind randomised controlled trial. BMJ Neurol Open. 2020 Mar 23;2(1):e000022. doi: 10.1136/bmjno-2019-000022. eCollection 2020.

  PMID: 33681776 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Ischemic Preconditioning

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Siva Nair

  Sheffield Teaching Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 15, 2017
• Study Start: April 5, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)