Single Exercise Session or Meal vs Control in SCI: Case Series

NCT03955523 | Completed

• 1 other identifier: Case series exercise/meal SCI
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Keywords

SCI; paraplegia; tetraplegia; quadriplegia; spinal cord

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Single exercise bout trial

EXPERIMENTAL

Exercise trial day: 30 min of continuous exercise at 60% VOpeak (or at the least 3 bouts of 10 min at 60% VO2peak separated by no more than 1 minute rest) - power output is set at that determined during the maximum test on the first visit, and adjusted accordingly if there is a deviation \>5% VO2peak for at least 3 minutes of exercise.

Other: Single exercise bout trial

Single diet trial

EXPERIMENTAL

Diet trial day The protocol of the diet trial day is identical to that of the exercise trial day, except that exercise is substituted by asking the participant to eat a standardized breakfast meal that it is commonly consumed in a fast-food chain (i.e. cheese and egg McMuffin, double portion of hash browns and an orange pop).

Dietary Supplement: Single diet trial

Control (doing nothing)

NO INTERVENTION

Non-exercise trial day The protocol of the non-exercise trial day is identical to that of the exercise trial day, except that exercise is substituted by 30 min of quiet sitting in a lounge area (e.g. reading, working or watching a movie on an electronic device) without further engagement with other people.

Interventions

Single exercise bout trial OTHER

Exercise trial day: 30 min of continuous exercise at 60% VOpeak (or at the least 3 bouts of 10 min at 60% VO2peak separated by no more than 1 minute rest) - power output is set at that determined during the maximum test on the first visit, and adjusted accordingly if there is a deviation \>5% VO2peak for at least 3 minutes of exercise.

Single exercise bout trial

Single diet trial DIETARY_SUPPLEMENT

Diet trial day The protocol of the diet trial day is identical to that of the exercise trial day, except that exercise is substituted by asking the participant to eat a standardized breakfast meal that it is commonly consumed in a fast-food chain (i.e. cheese and egg McMuffin, double portion of hash browns and an orange pop).

Single diet trial

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Location

Related Publications (6)

• 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.

  PMID: 30393565 BACKGROUND

• 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.

  PMID: 28319586 BACKGROUND

• 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.

  PMID: 22270190 BACKGROUND

• Dinoff A, Herrmann N, Swardfager W, Lanctot 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.

  PMID: 28493624 BACKGROUND

• 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.

  PMID: 30277850 BACKGROUND

• Todd KR, Van Der Scheer JW, Walsh JJ, Jackson GS, Dix GU, Little JP, Kramer JLK, Martin Ginis KA. The Impact of Sub-maximal Exercise on Neuropathic Pain, Inflammation, and Affect Among Adults With Spinal Cord Injury: A Pilot Study. Front Rehabil Sci. 2021 Oct 26;2:700780. doi: 10.3389/fresc.2021.700780. eCollection 2021.

  PMID: 36188763 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Quadriplegia

Condition Hierarchy (Ancestors)

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

Study Officials

• Kathleen Martin Ginis, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Case series: intraindividual analyses comparing single exercise trial vs single diet trial vs control (doing nothing)

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 20, 2019
• Study Start: January 6, 2019
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)