Single Exercise Session or Meal vs Control in SCI: Case Series
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

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.
    

Detailed description: 
      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

      The purpose of this pilot study is to examine the immediate effects of a single exercise
      session or a typical unhealthy meal on inflammation, immune cell count/phenotyping, brain
      function, pain, affect and perceived stress in people with SCI. Specific objectives are to
      compare the effects of a 30-min upper-body arm crank exercise session at 60% peak oxygen
      uptake or a high fat/high carbohydrate meal from a fast-food chain to a control condition in
      which participants sit quietly for 30 minutes. Outcomes selected will be:

        -  inflammation (measurement and function of cytokines IL-6, IL-10 and TNF-alpha)

        -  immune cell count/phenotyping (cell numbers per ml blood and percentage total leukocytes
           for monocytes, neutrophils, eosinophils, T cells, B cells and natural killer cells)

        -  brain function (task-switching test, Stroop test and BDNF]

        -  neuropathic pain (Neuropathic Pain Scale distinguishing 10 neuropathic pain qualities)

        -  - Musculoskeletal pain (Musculoskeletal Pain Scale measuring 2 dimensions of
           musculoskeletal pain qualities)

        -  affect (Feeling Scale and Felt Arousal Scale)

      Research design Given the novelty of this topic and pilot nature of this study, a case series
      study design is most appropriate: it will reduce the burden and cost of recruiting a
      relatively large group of people with SCI, while maximizing insight into intra-individual
      responses [Published case series of individuals with SCI typically include 5--10 cases This
      case series study will include 4 research visits on 4 separate days taking place across two
      weeks with a minimum of 48 h between days. After receiving the written informed consent via
      email or mail (see the sections on recruitment and obtaining consent below), the participant
      will be invited for the first visit: a screening/familiarisation visit. This first visit is
      followed by (in randomized order): an exercise trial day, a diet trial day and a control
      trial day. Further details on inclusion criteria, exclusion criteria, recruitment and study
      procedures are provided in the sections below.

      Statistical analysis Group descriptives (median, interquartile range, mean, standard
      deviation) will be calculated for all participant characteristics, outcome measures at the
      different time points, and the absolute and relative change in outcomes measures across the
      different time points.

      Data will be further analyzed at both the group level and the individual level. At the group
      level, ANOVA or non-parametric equivalent (subject to the distribution of the data) will be
      conducted to test whether outcomes change across the different time points and whether these
      changes are different from those observed in the control condition. At the individual level,
      data will be plotted for each participant to examine changes across the different time points
      on each trial day. Where necessary, further insight into individual patterns is gained by
      visualizing data
    

Intervention name(s): Single exercise bout trial; Single diet trial
Intervention type(s): Other; Dietary Supplement
Intervention description(s): 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.; 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).
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Case series: intraindividual analyses comparing single exercise trial vs single diet trial vs control (doing nothing)
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: SCI; paraplegia; tetraplegia; quadriplegia; spinal cord