Spinal Cord InjuriesNCT05954715
Ischaemic Preconditioning and Upper Body Exercise Performance in Persons With Spinal Cord Injury
A study testing Ischaemic Preconditioning in people with Spinal Cord Injuries, run by Loughborough University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Ischaemic Preconditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 or older
- Chronic spinal cord injury (>1 year post injury)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Rohit Bhide, MD contact
About this study
Official title: Does Ischaemic Preconditioning Improve Upper Body Exercise Performance in People With Spinal Cord Injury? A Feasibility Study
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.
Read more
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.
Read the detailed description
Once participants have signed informed consent, they will undergo the following procedures:
- Randomisation into IPC vs Sham group B. Researcher will offer a suitable time to perform the study recording. C. Participant will be requested to spare up to 3 hours to complete the intervention.
- Intervention session (IPC / Sham):
- Participant arrives.
- On arrival, after 10 minutes of seated rest, baseline heart rate and blood pressure (BP) will be measured.
- Two electrodes will be placed on the lateral triceps head for Electromyography (EMG) assessment during the triceps exercise capacity tests.
- To determine maximum voluntary contraction (MVC), a warm-up of 2 contractions each of a participant-estimated 50% MVC, 70% MVC, and 90% MVC, will first be performed. Participants will then undertake up to 5 maximal isometric contractions of the triceps, from which the MVC value will be obtained (average of the best 3 contractions).
- Following a rest period (5 minutes), a metronome will be used to give participants the cue to rhythmically isometrically contract their triceps (60 contraction-relaxation cycles/min) to a target value of 70% MVC.
- The time to task failure and ability to complete the exercise will be noted.
- Participants will report Rating of Perceived Exertion (RPE) using Borg's scale immediately after completing the exercise.
- Before and after the exercise, a capillary blood sample will be obtained from the earlobe for assessment of blood lactate concentration. Heart rate will be measured throughout.
- Repeat BP measurement.
- 30 minutes rest.
- Repeat BP and heart rate measurement.
- The MVC will be determined again, followed by a 5-minute rest.
- Proceed to intervention - 4 cycles of 5 minutes of IPC / Sham followed by 5 minutes of reperfusion. (Total 40 minutes).
- IPC intervention - This will involve tying the cuff of a manual BP apparatus around the upper arm and inflated to a minimum of 200 mmHg, or a pressure of 60 mmHg above the resting systolic BP, whichever is higher. The inflation will be maintained for 5 min followed by cuff deflation lasting 5 min. The cycle will be repeated four times.
- The Sham intervention will be delivered with the manual BP cuff tied to the upper arm. The cuff will be inflated 30 mm Hg below the diastolic BP for 5 min followed by deflation for 5 min. The cycle will be repeated four times.
- 10 minutes rest.
- Repeat pre-exercise capillary blood sample for determination of blood lactate concentration.
- Repeat 5 maximal isometric contractions of the triceps.
- Repeat a rest period of 5 min.
- Repeat rhythmic isometric triceps contraction exercise. Again, time to task failure and ability to complete the exercise will be noted.
- Repeat reading of Borg's Rating of Perceived Exertion (RPE) scale, post-exercise capillary blood sample, BP and heart rate measurements.
- Recording of adverse events and numerical pain scale, open ended discussion around perceptions and tolerability of IPC.
- 15 minutes rest.
- Repeat BP and heart rate measurement.
- Exit from study.
- Conditions
- Spinal Cord Injuries
- Being tested
- Ischaemic Preconditioning, Sham
- Keywords
- Exercise capacity, Tolerability, Ischaemic preconditioning, Maximal voluntary contraction, Time to task failure, Fatigue
- Medical subject headings
- Spinal Cord Injuries, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischaemic PreconditioningOther
Four cycles of cuff inflation each lasting 5 min in duration followed by a 5-min period of cuff deflation will be applied.
ShamOther
Four cycles of cuff inflation each lasting 5 min in duration followed by a 5-min period of cuff deflation will be applied.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Recruitment figures and tolerability will be collected throughout the 1 year study period.
Secondary outcomes (2)
Maximal voluntary muscle contraction
Maximal voluntary contraction of the triceps will be obtained before and after the intervention (IPC vs Sham).
Measured: 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 triceps contraction will be obtained before and after the intervention (IPC vs Sham). The time that rhythmic triceps contractions at 70% of maximal voluntary contraction can be maintained will be recorded.
Measured: Time to task failure during rhythmic muscle contraction will be collected throughout the 1 year study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Nov 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Acute single blind randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Sven Hoekstra, Loughborough University
- Investigators
- Christof Leicht, PhD, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954715
- Sponsor's protocol ID
- STH22013
- Status last verified
- Jul 2023
- First submitted
- 30 Jun 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ischaemic Preconditioning Improve Upper Body Exercise Performance in People With Spinal Cord Injury? A Feasibility Study
- ClinicalTrials.gov ID
- NCT05954715
- Acronym / sponsor ID
- STH22013
- Conditions
- Spinal Cord Injuries
- Keywords
- Exercise capacity, Tolerability, Ischaemic preconditioning, Maximal voluntary contraction, Time to task failure, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Once participants have signed informed consent, they will undergo the following procedures:
- Randomisation into IPC vs Sham group B. Researcher will offer a suitable time to perform the study recording. C. Participant will be requested to spare up to 3 hours to complete the intervention.
- Intervention session (IPC / Sham):
- Participant arrives.
- On arrival, after 10 minutes of seated rest, baseline heart rate and blood pressure (BP) will be measured.
- Two electrodes will be placed on the lateral triceps head for Electromyography (EMG) assessment during the triceps exercise capacity tests.
- To determine maximum voluntary contraction (MVC), a warm-up of 2 contractions each of a participant-estimated 50% MVC, 70% MVC, and 90% MVC, will first be performed. Participants will then undertake up to 5 maximal isometric contractions of the triceps, from which the MVC value will be obtained (average of the best 3 contractions).
- Following a rest period (5 minutes), a metronome will be used to give participants the cue to rhythmically isometrically contract their triceps (60 contraction-relaxation cycles/min) to a target value of 70% MVC.
- The time to task failure and ability to complete the exercise will be noted.
- Participants will report Rating of Perceived Exertion (RPE) using Borg's scale immediately after completing the exercise.
- Before and after the exercise, a capillary blood sample will be obtained from the earlobe for assessment of blood lactate concentration. Heart rate will be measured throughout.
- Repeat BP measurement.
- 30 minutes rest.
- Repeat BP and heart rate measurement.
- The MVC will be determined again, followed by a 5-minute rest.
- Proceed to intervention - 4 cycles of 5 minutes of IPC / Sham followed by 5 minutes of reperfusion. (Total 40 minutes).
- IPC intervention - This will involve tying the cuff of a manual BP apparatus around the upper arm and inflated to a minimum of 200 mmHg, or a pressure of 60 mmHg above the resting systolic BP, whichever is higher. The inflation will be maintained for 5 min followed by cuff deflation lasting 5 min. The cycle will be repeated four times.
- The Sham intervention will be delivered with the manual BP cuff tied to the upper arm. The cuff will be inflated 30 mm Hg below the diastolic BP for 5 min followed by deflation for 5 min. The cycle will be repeated four times.
- 10 minutes rest.
- Repeat pre-exercise capillary blood sample for determination of blood lactate concentration.
- Repeat 5 maximal isometric contractions of the triceps.
- Repeat a rest period of 5 min.
- Repeat rhythmic isometric triceps contraction exercise. Again, time to task failure and ability to complete the exercise will be noted.
- Repeat reading of Borg's Rating of Perceived Exertion (RPE) scale, post-exercise capillary blood sample, BP and heart rate measurements.
- Recording of adverse events and numerical pain scale, open ended discussion around perceptions and tolerability of IPC.
- 15 minutes rest.
- Repeat BP and heart rate measurement.
- Exit from study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Acute single blind randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| IPC (Ischaemic Preconditioning) | Experimental | Other: Ischaemic PreconditioningIPC 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. |
| Sham | Sham comparator | Other: ShamThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 18 or older
- Chronic spinal cord injury (>1 year post injury)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischaemic PreconditioningFour cycles of cuff inflation each lasting 5 min in duration followed by a 5-min period of cuff deflation will be applied. | Other | IPC (Ischaemic Preconditioning) |
| ShamFour cycles of cuff inflation each lasting 5 min in duration followed by a 5-min period of cuff deflation will be applied. | Other | Sham |
Primary outcome
Intervention feasibility
Time frame: Recruitment figures and tolerability will be collected throughout the 1 year study period.
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.
2 secondary outcomes
Maximal voluntary muscle contraction
Time frame: Maximal voluntary muscle contraction will be collected throughout the 1 year study period.
Time to task failure during rhythmic muscle contraction
Time frame: Time to task failure during rhythmic muscle contraction will be collected throughout the 1 year study period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohit Bhide, MD contact
Christof Leicht, PhD principal investigator
Loughborough University
Questions about this trial
What is this clinical trial studying?
A study testing Ischaemic Preconditioning in people with Spinal Cord Injuries, run by Loughborough University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sven Hoekstra, PhD (+447799115690, s.p.hoekstra@lboro.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention feasibility (time frame: Recruitment figures and tolerability will be collected throughout the 1 year study period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.