Practitioner-led, peer-group sports intervention combined with a context-focused intervention for children with cerebral palsy: a protocol of a feasibility randomised clinical trial.

BACKGROUND: There is a need to investigate relevant, acceptable and feasible approaches that promote participation in leisure-time physical activity for children with cerebral palsy (CP). The aim of this study is to assess the feasibility of a randomised controlled trial comparing a peer-group intervention focused on improving physical literacy (Sports Stars) with the combination of Sports Stars and a context-focused intervention (Pathways and Resources for Engagement and Participation, PREP) for ambulant children with CP in Brazil. METHODS: In this feasibility trial, 18 ambulant children (aged 6-12 years) with CP will be randomised into two groups (nine per group): (1) Sports Stars and (2) Sports Stars plus PREP. The Sports Stars group will receive 8 weekly group sessions, focusing on developing the physical, social, cognitive and psychological skills required to participate in popular Brazilian sports. The combined Sports Stars and PREP group will receive Sports Stars in addition to eight individual PREP sessions focused on overcoming environmental barriers to participation. The primary outcome will include feasibility measures: willingness to participate in an RCT, eligibility and recruitment rates, maintenance of evaluator blinding, acceptability of screening procedures and random allocation, feasibility of evaluating outcomes, contamination between the groups, intervention adherence, treatment satisfaction, understanding of the intervention and implementation resources. Additional instruments will be applied to obtain data related to leisure-time physical activity participation goals, overall participation (home, school and community), physical literacy, level of physical activity and family empowerment. Outcomes will be assessed before, after and 12 weeks after intervention. ETHICS AND DISSEMINATION: This feasibility trial has been approved by ethical Federal University of Minas Gerais' Ethics Review Committee (CAAE: 33238520.5.0000.5149). All potential subjects will provide written informed consent. The results of this study will be published in peer-reviewed journals and be presented at academic conferences. TRIAL REGISTRATION NUMBERS: RBR-4m3b4b6, U1111-1256-4998.

Aerobic Training Efficacy in Inflammation, Neurotrophins, and Function in Chronic Stroke Persons: A Randomized Controlled Trial Protocol.

BACKGROUND: Neuroinflammation is an important part of stroke pathophysiology and has both detrimental and beneficial effects after stroke. Besides that the enhancement of neurotrophins seems to be related to improvements in stroke recovery. Evidences suggest that exercise plays a role in modulating anti-inflammatory and neurotrophic effects. However, little is known about its impact in stroke survivors, mainly in chronic stroke. The purpose of this study is to investigate the efficacy of moderate-intensity treadmill exercise in changing inflammatory mediators, interleukin-6 (IL-6), soluble tumor necrosis factor receptors I and II (sTNFRI, sTNFRII), interleukin-10 (IL-10), and brain-derived neurotrophic factor (BDNF) levels in chronic stroke patients. The secondary objective is to investigate the effects of training in improve mobility and exercise capacity. METHODS: This is a randomized controlled trial. Chronic stroke patients will be randomized to an experimental or control group, and will receive group interventions three times per week, over 12 weeks. The experimental group will receive moderate-intensity (60%-80% of maximum heart rate reserve) treadmill exercise. Control group will perform walking training on the ground (<40% of maximum heart rate reserve). Primary outcomes include IL-6, sTNFRI, sTNFRII, IL-10, and BDNF levels. Secondary outcomes include mobility and exercise capacity. Outcomes will be measured at baseline, postintervention, and at the 4-week follow-up. DISCUSSION: The findings of this trial have the potential to provide important insights regarding the effects of an aerobic physical program in the inflammatory process and in the neuronal plasticity in stroke persons and its impact on mobility and exercise capacity.