Spinal Cord Injuries Clinical Trial
Official title:
Effects of a Single Exercise Session or Meal on Physical and Mental Health of People With Spinal Cord Injury: a Case Series Study
Verified date | February 2020 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine the immediate effects of a single exercise session or a high fat/high carbohydrate meal on the physical and mental health of people with a spinal cord injury (SCI). Specifically, we want to better understand the responses in people with SCI when they conduct exercise or eat an unhealthy meal, when looking at inflammation levels, the number and function of immune cells, brain function, pain and how one feels (affect). If we can understand these responses, then clinicians, sports practitioners and dieticians can provide better advice to people with SCI.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 29, 2019 |
Est. primary completion date | November 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Published case series of individuals with spinal cord injury (SCI) typically include 5-10 cases (Todd & Martin Ginis, 2018). For this study, we aim to include 7 individuals who are provincial wheelchair rugby players or individuals who train for an equivalently high-intensity sport (e.g. wheelchair racing, hand cycle racing, para alpine skiing) - all participants should be performing training at least 3 times per week at a high-intensity. Men and women are recruited through community partners in the Okanagan region, if aged 18+, with chronic spinal cord injury (longer than 1 year post-injury), injury levels at the third cervical level or below (as long as diaphragmatic control and arm functioning allow upper-body exercise), American Spinal Cord Injury Association Impairment Scale classifications A-D, upper-arm veins accommodating 3 venepunctures per day, the ability to read and write in English, and no contraindications to maximal exercise based on the latest guidelines of the American College of Sports Medicine (2013). These individuals are sampled to ensure participants are accustomed and acclimated to exercise (both the peak aerobic exercise test and the 30 min of exercise at 60% VO2peak (i.e. moderate to vigorous intensity). Exclusion Criteria: - Excluded are people with SCI who do not meet the inclusion criteria and/or: - are not able to refrain from anti-inflammatory medication (e.g. Ibuprofen, Naproxen, Tylenol) for at least 24h before each trial day - have a clinically diagnosed metabolic disorder (e.g. diabetes, hypothyroidism), progressive disease (e.g. multiple sclerosis) or mental disorder (e.g. depression) - are pregnant Responses of these individuals are not considered to represent those that can be expected in the general population with spinal cord injury (SCI), which is the population that this study is targeting. |
Country | Name | City | State |
---|---|---|---|
Canada | University of British Columbia Okanagan | Kelowna | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Allison DJ, Beaudry KM, Thomas AM, Josse AR, Ditor DS. Changes in nutrient intake and inflammation following an anti-inflammatory diet in spinal cord injury. J Spinal Cord Med. 2019 Nov;42(6):768-777. doi: 10.1080/10790268.2018.1519996. Epub 2018 Oct 2. — View Citation
Barry JC, Simtchouk S, Durrer C, Jung ME, Little JP. Short-Term Exercise Training Alters Leukocyte Chemokine Receptors in Obese Adults. Med Sci Sports Exerc. 2017 Aug;49(8):1631-1640. doi: 10.1249/MSS.0000000000001261. Erratum in: Med Sci Sports Exerc. 2018 Apr;50(4):879. — View Citation
Dinoff A, Herrmann N, Swardfager W, Lanctôt KL. The effect of acute exercise on blood concentrations of brain-derived neurotrophic factor in healthy adults: a meta-analysis. Eur J Neurosci. 2017 Jul;46(1):1635-1646. doi: 10.1111/ejn.13603. Epub 2017 Jun 19. Review. — View Citation
Post MW, van Leeuwen CM. Psychosocial issues in spinal cord injury: a review. Spinal Cord. 2012 May;50(5):382-9. doi: 10.1038/sc.2011.182. Epub 2012 Jan 24. Review. — View Citation
Todd KR, Martin Ginis KA. An examination of diurnal variations in neuropathic pain and affect, on exercise and non-exercise days, in adults with spinal cord injury. Spinal Cord Ser Cases. 2018 Oct 27;4:94. doi: 10.1038/s41394-018-0130-3. eCollection 2018. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cytokine profile | Plasma cytokines (IL6, IL10, TNFalpha) will be measured in plasma by Milliplex® high-sensitivity assay on a MagPIX® multiplex reader. | Before, immediately after and 2 hours post-baseline | |
Primary | Immunephenotyping profile | Immediately after taking the venous blood sample, immune cell counts will be quantified using the 8-Color Immunophenotyping Kit (130-120-640, Miltenyi Biotec) on a MACSQuant Analyzer 10 Flow Cytometer (Miltenyi Biotec) [3, 4]. Cell numbers per ml blood and percentage total leukocytes for monocytes, neutrophils, eosinophils, T cells, B cells and natural killer cells will be assessed to determine the impact of exercise on the major circulating leukocyte populations. | Before, immediately after and 2 hours post-baseline | |
Primary | BDNF | Plasma samples will be collected in 3mL EDTA blood tubes and serum will be collected in 3mL serum separator tubes. Samples will be analyzed using a commercially available enzyme-linked immunosorbent assay in accordance with the manufacturer's instructions (Quantikine DBD00 BDNF ELISA, RnD Systems) | Before, immediately after and 2 hours post-baseline | |
Primary | Cognitive Function | Cognitive function will be assessed using a battery of 2 psychometrically valid tests (task-switching test and Stroop test) administered via a tablet-based app (BrainBaseline, Digital Artefacts). These tests measure selective attention, inhibitory control, and processing speed and will be used given their sensitivity to improvement following an acute bout of exercise [6]. Each test will take less than 3 minutes to complete. There is no prognostic validity to these tests (i.e., assessing cognitive impairment), rather they are intended to demonstrate within- and between-subject changes for research purposes. There are no risks associated with this measure. | Before, immediately after and 2 hours post-baseline | |
Primary | Neuropathic pain | Neuropathic pain scale, with one question adapted in accordance with repeated measurements of neuropathic pain. | Before, immediately after and 2 hours post-baseline | |
Primary | Musculoskeletal pain. | Musculoskeletal pain will be measured with a momentary pain intensity scale (2-item, 10 point scale) that has been adapted to be specific for Musculoskeletal pain. | Before, immediately after and 2 hours post-baseline | |
Primary | Affect | Felt Arousal Scale (6-point, single item scale) and Feeling Scale (11-point, single item scale measures participants' overall feeling of pleasure-displeasure, i.e. -5 = very bad, +5 = very good) | Before, immediately after and 2 hours post-baseline |
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