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Ischaemic Preconditioning and Upper Body Exercise Performance in Persons With Spinal Cord Injury

NCT05954715 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-02

No results posted yet for this study

Summary

Regular physical activity improves physical fitness, fatigue, quality of life, gait and reduces progression of the disability in persons with SCI. However, persons with SCI are less physically active than the general population. Approximately 50% of people with SCI experience fatigue which impacts their daily activities.

Ischaemic preconditioning (IPC) is exposure of the body to brief periods of circulatory occlusion and reperfusion to protect organs against ischaemic injury. Recent studies have shown that IPC also improves exercise performance in healthy participants. The aim of this study is to determine whether it is feasible to use IPC to improve upper-body exercise performance in people with SCI.

Setting: Potential candidates will be identified from the Outpatient clinic at the Princess Royal Spinal Injuries Hospital (PRSCIC), Northern General Hospital, Sheffield.

Design: Acute single blind randomised controlled trial. Forty patients with SCI above 18 years and with preserved triceps function to conduct triceps strength testing will be randomised to receive either an IPC or sham intervention.

Interventions: IPC will be administered to the upper limb using cuff inflation pressures of 200 mmHg or 60mm Hg above the systolic BP (whichever is higher). Four cycles of cuff inflation each lasting 5 min in duration followed by 5-min period of cuff deflation will be applied. The Sham intervention will be administered with a BP cuff over the upper arm being inflated at a pressure 30mmg Hg below the diastolic blood pressure. The sham cycles will comprise of four cycles of cuff inflation each lasting 5 min in duration followed by 5-min period of cuff deflation.

Researchers will assess the feasibility of IPC as well as its efficacy to improve triceps maximal voluntary contraction and endurance compared with Sham.

Conditions

  • Spinal Cord Injuries

Interventions

OTHER

Ischaemic Preconditioning

Four cycles of cuff inflation each lasting 5 min in duration followed by a 5-min period of cuff deflation will be applied.

OTHER

Sham

Four cycles of cuff inflation each lasting 5 min in duration followed by a 5-min period of cuff deflation will be applied.

Sponsors & Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

    collaborator OTHER

  • Loughborough University

    lead OTHER

Principal Investigators

  • Christof Leicht, PhD · Loughborough University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-12-31
Completion
2025-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05954715 on ClinicalTrials.gov