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| Name | Class |
|---|---|
| Sheffield Teaching Hospitals NHS Foundation Trust | OTHER |
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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.
Once participants have signed informed consent, they will undergo the following procedures:
A. 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.
D. Intervention session (IPC / Sham):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intervention feasibility | The intervention will be considered feasible if all of the below criteria are met:
| Recruitment figures and tolerability will be collected throughout the 1 year study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal voluntary muscle contraction | Maximal voluntary contraction of the triceps will be obtained before and after the intervention (IPC vs Sham). | Maximal voluntary muscle contraction will be collected throughout the 1 year study period. |
| Time to task failure during rhythmic muscle contraction |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lactate concentration | Blood lactate concentration will be determined in a capillary blood sample obtained from the earlobe before and after the intervention. | Blood lactate concentration will be collected throughout the 1 year study period. |
| Ratings of perceived exertion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sven Hoekstra, PhD | Contact | +447799115690 | s.p.hoekstra@lboro.ac.uk | |
| Rohit Bhide, MD | Contact | rohit.bhide@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Christof Leicht, PhD | Loughborough University | Principal Investigator |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D019194 | Ischemic Preconditioning |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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Acute single blind randomised controlled trial
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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.
| 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. |
|
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. |
| Time to task failure during rhythmic muscle contraction will be collected throughout the 1 year study period. |
Ratings of perceived exertion will be reported immediately following the exercise capacity tests of the triceps. |
| Ratings of perceived extertion will be collected throughout the 1 year study period. |
| Electromyographic activity (EMG) at the triceps head | As an exploratory measure, EMG activity will be measured during the exercise capacity tests before and after the intervention at the head of the triceps. Fourier transformation of the EMG signal will be performed and compared between conditions at key time points as well as averaged over the entire test period. | Electromyographic activity (EMG) at the triceps head will be collected throughout the 1 year study period. |
| D014947 | Wounds and Injuries |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |