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临床试验/NCT03955523
NCT03955523已完成不适用

Effects of a Single Exercise Session or Meal on Physical and Mental Health of People With Spinal Cord Injury: a Case Series Study

University of British Columbia1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年1月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Immunephenotyping profile

研究概览

简要总结

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.

详细描述

Background / justification Exercise training and diet interventions can influence the chronic low-grade inflammatory state common among people with SCI. However, little is known about mechanisms underlying such changes. In SCI, changes in cytokines reflecting an inflammatory state are observed after long-term exercise training and diet interventions. After a single exercise bout, mixed results in cytokine responses have been observed, while the effects of a single meal on cytokines responses have never been studied in SCI. As indicated by research in other clinical populations, changes in immune cell count and immunephenotyping may precede and underlie changes in an inflammatory state. Given immunological changes post-SCI, this hypothesis needs to be tested in people with SCI.

Similarly, very little is known about exercise-induced changes in cognitive function in people with SCI, despite the improvements found in other clinical populations. One mechanism potentially underlying the effects of exercise on cognition, is an increase in brain-derived neurotrophic factor (BDNF), which has been observed in able-bodied people after a single bout of exercise Given cerebrovascular changes and potential cognitive dysfunction post-SCI this hypothesis needs to be tested in people with SCI.

Exercise training has also been identified as a potential strategy for improving mental health in adults with SCI who on average report poorer mental health than adults without disabilities However, little is known about mechanisms underlying positive effects of exercise on mental health of people with SCI. It is not clear whether a single standardised exercise bout immediately leads to improvements in affect and perceived stress, and if positive effects of a single exercise bout are mediated by reductions in neuropathic pain Additionally, exercise has been reported to be effective in the alleviation of other types of pain commonly experienced by people with SCI, for example musculoskeletal (MSK) pain. Conducting an exercise intervention in accordance with validated international SCI exercise guidelines for improving cardiometabolic health will not only allow us to determine the effects of the guidelines on MSK and NP pain, but also identify potential mechanisms by which exercise reduces pain.

Taken together, SCI pilot data is needed to gain support for the inclusion of the above-described outcomes in long-term exercise training or diet intervention studies (e.g. RCTs). Such evidence is needed to understand how exercise training and diet interventions for people with SCI can be maximally effective. Ultimately, this will allow clinicians, sports practitioners and dieticians to provide better advice to people with SCI, and provide people with SCI with the opportunity to make evidence-based health choices.

Purpose and objectives

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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).

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Single exercise bout trial (Other)

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).

干预措施: Single diet trial (Dietary Supplement)

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.

结局指标

主要结局

Immunephenotyping profile

时间窗: Before, immediately after and 2 hours post-baseline

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.

Affect

时间窗: Before, immediately after and 2 hours post-baseline

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)

BDNF

时间窗: Before, immediately after and 2 hours post-baseline

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)

Cognitive Function

时间窗: Before, immediately after and 2 hours post-baseline

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.

Neuropathic pain

时间窗: Before, immediately after and 2 hours post-baseline

Neuropathic pain scale, with one question adapted in accordance with repeated measurements of neuropathic pain.

Musculoskeletal pain.

时间窗: Before, immediately after and 2 hours post-baseline

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.

Cytokine profile

时间窗: Before, immediately after and 2 hours post-baseline

Plasma cytokines (IL6, IL10, TNFalpha) will be measured in plasma by Milliplex® high-sensitivity assay on a MagPIX® multiplex reader.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Martin Ginis

professor

University of British Columbia

研究点 (1)

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