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

NCT05954715 | Unknown

• 1 other identifier: STH22013
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Exercise capacity; Tolerability; Ischaemic preconditioning; Maximal voluntary contraction; Time to task failure; Fatigue

Outcome Measures

Primary Outcomes (1)

• Intervention feasibility

  The intervention will be considered feasible if all of the below criteria are met: * 80% of the target sample is recruited within the first 9 months after the start of recruitment. * Of those who participate, 80% tolerate the ischemic preconditioning intervention, defined as ratings \<7 using the numerical Pain Rating Scale that ranges from 0 to 10. Here 0 is considered no pain; 1 to 3 is mild pain; 4 to 6 is moderate pain and 7 to 10 is severe pain. * A full data set is obtained in 80% of the participants who start the intervention.

  Recruitment figures and tolerability will be collected throughout the 1 year study period.

Secondary Outcomes (2)

• Maximal voluntary muscle contraction

  Maximal voluntary muscle contraction will be collected throughout the 1 year study period.

• Time to task failure during rhythmic muscle contraction

  Time to task failure during rhythmic muscle contraction will be collected throughout the 1 year study period.

Other Outcomes (3)

• Blood lactate concentration

  Blood lactate concentration will be collected throughout the 1 year study period.

• Ratings of perceived exertion

  Ratings of perceived extertion will be collected throughout the 1 year study period.

• Electromyographic activity (EMG) at the triceps head

  Electromyographic activity (EMG) at the triceps head will be collected throughout the 1 year study period.

Study Arms (2)

IPC (Ischaemic Preconditioning)

EXPERIMENTAL

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 a 5-min period of cuff deflation will be applied.

Other: Ischaemic Preconditioning

Sham

SHAM COMPARATOR

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 a 5-min period of cuff deflation.

Other: Sham

Interventions

Ischaemic Preconditioning OTHER

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

IPC (Ischaemic Preconditioning)

Sham OTHER

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

Sham

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 or older
• Chronic spinal cord injury (\>1 year post injury)

You may not qualify if:

• ASIA Impairment scale E
• Other co-morbidities- Traumatic brain injury, Brachial plexus injury, upper limb fractures, progressive neurological conditions (e.g., multiple sclerosis)
• Patients known to have autonomic dysreflexia (AD) and having had an episode of AD in the last two weeks
• Impaired triceps function (medical research council (MRC) power motor score of 3 out of 5, or lower)
• Resting systolic BP of 170 mmHg or more
• Inability to communicate in English

Sponsors & Collaborators

• Loughborough University: lead
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Spinal Cord Injuries; Fatigue

Interventions

Ischemic Preconditioning; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Christof Leicht, PhD

  Loughborough University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sven Hoekstra, PhD

CONTACT

+447799115690; s.p.hoekstra@lboro.ac.uk

Rohit Bhide, MD

CONTACT

rohit.bhide@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Both Sham and IPC consist of 5 min bouts of cuff inflation, using an identical cuff. While the applied pressure will differ between conditions, this will not be communicated with the study participants prior to the experiment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Physiology and Rehabilitation Sciences

Model Details: Acute single blind randomised controlled trial

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 20, 2023
• Study Start: November 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share