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Therapeutic Lifestyle Intervention Targeting Enhanced Cardiometabolic Health and Function for Persons with Chronic Spinal Cord Injury in Caregiver/Care-Receiver Co-Treatment: A Study Protocol of a Multisite Randomized Controlled Trial.
Bigford, GE, Betancourt, LF, Charlifue, S, Nash, MS
International journal of environmental research and public health. 2023;(19)
Abstract
BACKGROUND Chronic spinal cord injury (SCI) significantly accelerates morbidity and mortality, partly due to the increased risk of cardiometabolic diseases (CMD), including neurogenic obesity, dyslipidemia, and impaired glucose metabolism. While exercise and dietary interventions have shown some transient benefits in reducing CMD risk, they often fail to improve clinically relevant disease markers and cardiovascular events. Moreover, SCI also places caregiving demands on their caregivers, who themselves experience health and functional decline. This underscores the need for more substantial interventions that incorporate appropriate physical activity, heart-healthy nutrition, and behavioral support tailored to the SCI population. OBJECTIVES This randomized clinical trial (RCT) protocol will (1) assess the health and functional effects, user acceptance, and satisfaction of a 6-month comprehensive therapeutic lifestyle intervention (TLI) adapted from the National Diabetes Prevention Program (DPP) for individuals with chronic SCI and (2) examine the impact of a complementary caregiver program on the health and function of SCI caregivers and evaluate user acceptance and satisfaction. Caregivers (linked with their partners) will be randomized to 'behavioral support' or 'control condition'. METHODS Dyadic couples comprise individuals with SCI (18-65 years, >1-year post-injury, ASIA Impairment Scale A-C, injury levels C5-L1) and non-disabled SCI caregivers (18-65 years). Both groups undergo lock-step circuit resistance training, a calorie-restricted Mediterranean-style diet, and 16 educational sessions focused on diet/exercise goals, self-monitoring, psychological and social challenges, cognitive behavioral therapy, and motivational interviewing. The outcome measures encompass the cardiometabolic risks, cardiorespiratory fitness, inflammatory stress, multidimensional function, pain, life quality, independence, self-efficacy, program acceptance, and life satisfaction for SCI participants. The caregiver outcomes include multidimensional function, pain, quality of life, independence, and perceived caregiver burden. DISCUSSION/CONCLUSIONS This study evaluates the effects and durability of a structured, multi-modal intervention on health and function. The results and intervention material will be disseminated to professionals and consumers for broader implementation. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT02853149 Registered 2 August 2016.
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Energy expenditure and nutrient intake after spinal cord injury: a comprehensive review and practical recommendations.
Farkas, GJ, Sneij, A, McMillan, DW, Tiozzo, E, Nash, MS, Gater, DR
The British journal of nutrition. 2022;(5):863-887
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Abstract
Many persons with spinal cord injury (SCI) have one or more preventable chronic diseases related to excessive energetic intake and poor eating patterns. Appropriate nutrient consumption relative to need becomes a concern despite authoritative dietary recommendations from around the world. These recommendations were developed for the non-disabled population and do not account for the injury-induced changes in body composition, hypometabolic rate, hormonal dysregulation and nutrition status after SCI. Because evidence-based dietary reference intake values for SCI do not exist, ensuring appropriate consumption of macronutrient and micronutrients for their energy requirements becomes a challenge. In this compressive review, we briefly evaluate aspects of energy balance and appetite control relative to SCI. We report on the evidence regarding energy expenditure, nutrient intake and their relationship after SCI. We compare these data with several established nutritional guidelines from American Heart Association, Australian Dietary Guidelines, Dietary Guidelines for Americans, Institute of Medicine Dietary Reference Intake, Public Health England Government Dietary Recommendations, WHO Healthy Diet and the Paralyzed Veterans of America (PVA) Clinical Practice Guidelines. We also provide practical assessment and nutritional recommendations to facilitate a healthy dietary pattern after SCI. Because of a lack of strong SCI research, there are currently limited dietary recommendations outside of the PVA guidelines that capture the unique nutrient needs after SCI. Future multicentre clinical trials are needed to develop comprehensive, evidence-based dietary reference values specific for persons with SCI across the care continuum that rely on accurate, individual assessment of energy need.
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Exercise to mitigate cardiometabolic disorders after spinal cord injury.
Nash, MS, Farkas, GJ, Tiozzo, E, Gater, DR
Current opinion in pharmacology. 2022;:4-11
Abstract
The cardiometabolic disorder (CMD) is a syndrome caused by coalescing of cardiovascular, endocrine, pro-thrombotic, and inflammatory health risks. Together, these risks confer a hazard as health-threatening as coronary artery disease or type2 diabetes, whether an individual has a diagnosis of coronary disease or diabetes, or not. CMD is most often defined by three or more of five clinically assessed risk components, notably obesity, insulin resistance, hypertension, hypertriglyceridemia, and depressed high-density lipoprotein cholesterol. Evidence currently suggests that worldwide CMD is expanding at a pandemic rate, and it is known that people living with spinal cord injuries (SCI) qualify for the diagnosis at more than 50% of the prevalence of a non-disabled cohort. A recent evidence-based guideline warned of the current state of CMD following SCI and recommended early lifestyle intervention incorporating exercise and prudent nutrition as a first-line disease countermeasure. This monograph will define the CMD following SCI, explore its underlying pathophysiology, and provide evidence that recommends exercise for CMD health hazards after SCI.
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Acute Spinal Cord Injury Is Associated With Prevalent Cardiometabolic Risk Factors.
Solinsky, R, Betancourt, L, Schmidt-Read, M, Kupfer, M, Owens, M, Schwab, JM, Dusseau, NB, Szlachcic, Y, Sutherland, L, Taylor, JA, et al
Archives of physical medicine and rehabilitation. 2022;(4):696-701
Abstract
OBJECTIVES To (1) describe the prevalence of cardiometabolic disease (CMD) at spinal cord injury (SCI) rehabilitation discharge; (2) compare this with controls without SCI; and (3) identify factors associated with increased CMD. DESIGN Multicenter, prospective observational study. SETTING Five National Institute on Disability, Independent Living, and Rehabilitation Research Model SCI Rehabilitation Centers. PARTICIPANTS SCI (n=95): patients aged 18-70 years, with SCI (neurologic levels of injury C2-L2, American Spinal Injury Association Impairment Scale grades A-D), and enrolled within 2 months of initial rehabilitation discharge. Control group (n=1609): age/sex/body mass index-matched entries in the National Health and Nutrition Examination Education Survey (2016-2019) (N=1704). INTERVENTIONS None MAIN OUTCOME MEASURES Percentage of participants with SCI with CMD diagnosis, prevalence of CMD determinants within 2 months of rehabilitation discharge, and other significant early risk associations were analyzed using age, sex, body mass index, insulin resistance (IR) by fasting glucose and Homeostasis Model Assessment (v.2), fasting triglycerides, high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol, total cholesterol, and resting blood pressure (systolic and diastolic). RESULTS Participants with SCI had significantly higher diastolic blood pressure and triglycerides than those without SCI, with lower fasting glucose and HDL-C. A total of 74.0% of participants with SCI vs 38.5% of those without SCI were obese when applying population-specific criteria (P<.05). Low HDL-C was measured in 54.2% of participants with SCI vs 15.4% of those without (P<.05). IR was not significantly different between groups. A total of 31.6% of participants with SCI had ≥3 CMD determinants, which was 40.7% higher than those without SCI (P<.05). Interplay of lipids and lipoproteins (ie, total cholesterol:HDL-C ratio and triglyceride:HDL-C ratio) were associated with elevated risk in participants with SCI for myocardial infarction and stroke. The only significant variable associated with CMD was age (P<.05). CONCLUSIONS Individuals with SCI have an increased CMD risk compared with the general population; obesity, IR, and low HDL-C are the most common CMD risk determinants; age is significantly associated with early CMD.
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Phase 1 Safety Trial of Autologous Human Schwann Cell Transplantation in Chronic Spinal Cord Injury.
Gant, KL, Guest, JD, Palermo, AE, Vedantam, A, Jimsheleishvili, G, Bunge, MB, Brooks, AE, Anderson, KD, Thomas, CK, Santamaria, AJ, et al
Journal of neurotrauma. 2022;(3-4):285-299
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Abstract
A phase 1 open-label, non-randomized clinical trial was conducted to determine feasibility and safety of autologous human Schwann cell (ahSC) transplantation accompanied by rehabilitation in participants with chronic spinal cord injury (SCI). Magnetic resonance imaging (MRI) was used to screen eligible participants to estimate an individualized volume of cell suspension to be implanted. The trial incorporated standardized multi-modal rehabilitation before and after cell delivery. Participants underwent sural nerve harvest, and ahSCs were isolated and propagated in culture. The dose of culture-expanded ahSCs injected into the chronic spinal cord lesion of each individual followed a cavity-filling volume approach. Primary outcome measures for safety and trend-toward efficacy were assessed. Two participants with American Spinal Injury Association Impairment Scale (AIS) A and two participants with incomplete chronic SCI (AIS B, C) were each enrolled in cervical and thoracic SCI cohorts (n = 8 total). All participants completed the study per protocol, and no serious adverse events related to sural nerve harvest or ahSC transplantation were reported. Urinary tract infections and skin abrasions were the most common adverse events reported. One participant experienced a 4-point improvement in motor function, a 6-point improvement in sensory function, and a 1-level improvement in neurological level of injury. Follow-up MRI in the cervical (6 months) and thoracic (24 months) cohorts revealed a reduction in cyst volume after transplantation with reduced effect over time. This phase 1 trial demonstrated the feasibility and safety of ahSC transplantation combined with a multi-modal rehabilitation protocol for participants with chronic SCI.
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Exercise Interventions Targeting Obesity in Persons With Spinal Cord Injury.
McMillan, DW, Maher, JL, Jacobs, KA, Nash, MS, Gater, DR
Topics in spinal cord injury rehabilitation. 2021;(1):109-120
Abstract
Spinal cord injury (SCI) results in an array of cardiometabolic complications, with obesity being the most common component risk of cardiometabolic disease (CMD) in this population. Recent Consortium for Spinal Cord Medicine Clinical Practice Guidelines for CMD in SCI recommend physical exercise as a primary treatment strategy for the management of CMD in SCI. However, the high prevalence of obesity in SCI and the pleiotropic nature of this body habitus warrant strategies for tailoring exercise to specifically target obesity. In general, exercise for obesity management should aim primarily to induce a negative energy balance and secondarily to increase the use of fat as a fuel source. In persons with SCI, reductions in the muscle mass that can be recruited during activity limit the capacity for exercise to induce a calorie deficit. Furthermore, the available musculature exhibits a decreased oxidative capacity, limiting the utilization of fat during exercise. These constraints must be considered when designing exercise interventions for obesity management in SCI. Certain forms of exercise have a greater therapeutic potential in this population partly due to impacts on metabolism during recovery from exercise and at rest. In this article, we propose that exercise for obesity in SCI should target large muscle groups and aim to induce hypertrophy to increase total energy expenditure response to training. Furthermore, although carbohydrate reliance will be high during activity, certain forms of exercise might induce meaningful postexercise shifts in the use of fat as a fuel. General activity in this population is important for many components of health, but low energy cost of daily activities and limitations in upper body volitional exercise mean that exercise interventions targeting utilization and hypertrophy of large muscle groups will likely be required for obesity management.
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Cardiometabolic Disease and Dysfunction Following Spinal Cord Injury: Origins and Guideline-Based Countermeasures.
Nash, MS, Gater, DR
Physical medicine and rehabilitation clinics of North America. 2020;(3):415-436
Abstract
The risks and health hazards of the cardiometabolic syndrome (CMS) are commonly reported in persons with spinal cord injuries (SCIs) and disorders. Overweight/obesity, insulin resistance, hypertension, and dyslipidemia are highly prevalent after SCI. Both the CMS diagnosis and physical deconditioning worsen the prognosis for all-cause cardiovascular disease. Evidence suggests a role for physical activity to address these risks, although intense exercise may be required. A lifestyle plan incorporating both exercise and nutrition represents a preferred approach for health management. Improved surveillance for CMS risks and exercise and nutritional management are essential for the preservation of optimal health and independence.
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Influence of upper-body continuous, resistance or high-intensity interval training (CRIT) on postprandial responses in persons with spinal cord injury: study protocol for a randomised controlled trial.
McMillan, DW, Maher, JL, Jacobs, KA, Mendez, AJ, Nash, MS, Bilzon, JLJ
Trials. 2019;(1):497
Abstract
BACKGROUND Chronic spinal cord injury (SCI) increases morbidity and mortality associated with cardiometabolic diseases, secondary to increases in central adiposity, hyperlipidaemia and impaired glucose tolerance. While upper-body Moderate Intensity Continuous Training (MICT) improves cardiorespiratory fitness, its effects on cardiometabolic component risks in adults with SCI appear relatively modest. The aim of this study is to assess the acute effects of Continuous Resistance Training (CRT), High Intensity Interval Training (HIIT), MICT and rest (CON) on fasting and postprandial systemic biomarkers and substrate utilisation. METHODS Eleven healthy, chronic SCI (> 1 year, ASIA A-C) men will be recruited. Following preliminary testing, each will complete four experimental conditions, where they will report to the laboratory following an ~ 10-h overnight fast. A venous blood sample will be drawn and expired gases collected to estimate resting metabolic rate (RMR). In order to ensure an isocaloric exercise challenge, each will complete CRT first, with the remaining three conditions presented in randomised order: (1) CRT, ~ 45 min of resistance manoeuvres (weight lifting) interspersed with low-resistance, high-speed arm-crank exercise; (2) CON, seated rest; (3) MICT, ~ 45 min constant arm-crank exercise at a resistance equivalent to 30-40% peak power output (PPO) and; (4) HIIT, ~ 35 min arm-crank exercise with the resistance alternating every 2 min between 10% PPO and 70% PPO. After each ~ 45-min condition, participants will ingest a 2510-kJ liquid test meal (35% fat, 50% carbohydrate, 15% protein). Venous blood and expired gas samples will be collected at the end of exercise and at regular intervals for 120 min post meal. DISCUSSION This study should establish the acute effects of different forms of exercise on fasting and postprandial responses in chronic SCI male patients. Measures of glucose clearance, insulin sensitivity, lipid and inflammatory biomarker concentrations will be assessed and changes in whole-body substrate oxidation estimated from expired gases. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT03545867 . Retrospectively registered on 1 June 2018.
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Body System Effects of a Multi-Modal Training Program Targeting Chronic, Motor Complete Thoracic Spinal Cord Injury.
Gant, KL, Nagle, KG, Cowan, RE, Field-Fote, EC, Nash, MS, Kressler, J, Thomas, CK, Castellanos, M, Widerström-Noga, E, Anderson, KD
Journal of neurotrauma. 2018;(3):411-423
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Abstract
The safety and efficacy of pharmacological and cellular transplantation strategies are currently being evaluated in people with spinal cord injury (SCI). In studies of people with chronic SCIs, it is thought that functional recovery will be best achieved when drug or cell therapies are combined with rehabilitation protocols. However, any functional recovery attributed to the therapy may be confounded by the conditioned state of the body and by training-induced effects on neuroplasticity. For this reason, we sought to investigate the effects of a multi-modal training program on several body systems. The training program included body-weight-supported treadmill training for locomotion, circuit resistance training for upper body conditioning, functional electrical stimulation for activation of sublesional muscles, and wheelchair skills training for overall mobility. Eight participants with chronic, thoracic-level, motor-complete SCI completed the 12-week training program. After 12 weeks, upper extremity muscular strength improved significantly for all participants, and some participants experienced improvements in function, which may be explained by increased strength. Neurological function did not change. Changes in pain and spasticity were highly variable between participants. This is the first demonstration of the effect of this combination of four training modalities. However, balancing participant and study-site burden with capturing meaningful outcome measures is also an important consideration.
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Exercise and Health-Related Risks of Physical Deconditioning After Spinal Cord Injury.
Maher, JL, McMillan, DW, Nash, MS
Topics in spinal cord injury rehabilitation. 2017;(3):175-187
Abstract
A sedentary lifestyle occurring soon after spinal cord injury (SCI) may be in contrast to a preinjury history of active physical engagement and is thereafter associated with profound physical deconditioning sustained throughout the lifespan. This physical deconditioning contributes in varying degrees to lifelong medical complications, including accelerated cardiovascular disease, insulin resistance, osteopenia, and visceral obesity. Unlike persons without disability for whom exercise is readily available and easily accomplished, exercise options for persons with SCI are more limited. Depending on the level of injury, the metabolic responses to acute exercise may also be less robust than those accompanying exercise in persons without disability, the training benefits more difficult to achieve, and the risks of ill-considered exercise both greater and potentially irreversible. For exercise to ultimately promote benefit and not impose additional impairment, an understanding of exercise opportunities and risks if exercise is undertaken by those with SCI is important. The following monograph will thus address common medical challenges experienced by persons with SCI and typical modes and benefits of voluntary exercise conditioning.