The effect of breathing exercises and mindset with or without cold exposure on mental and physical health in persons with a spinal cord injury-a protocol for a three-arm randomised-controlled trial.

STUDY DESIGN: A three-arm randomized controlled trial. OBJECTIVES: To investigate the effects of the Wim Hof Method (WHM), with (WHM-C) and without cold exposure (WHM-NC), on mental and physical health in persons with chronic spinal cord injury (SCI). SETTING: Rehabilitation centre (assessments and once-weekly intervention sessions) and home-based (daily intervention sessions). METHODS: Sixty adults with chronic SCI will be randomised (1:1:1) to one of three groups: participants in the intervention groups (i.e., WHM-C and WHM-NC) will engage in a 7-week intervention, with one weekly practice session at the rehabilitation centre and a daily WHM session at home. WHM-NC will consist of breathing exercises and mindset, while participants in WHM-C will partake in breathing exercises, mindset and cold exposure. Participants allocated to usual care (UC) will not receive the WHM intervention. The primary outcome is mental health reported via the Mental Health Inventory (MHI)-5, while secondary outcomes include circulating inflammatory and metabolic marker concentration, pulmonary function, body composition, sleep quality, spasticity, chronic pain and psychological stress. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the medical ethics committee of the Máxima Medical Centre (Veldhoven, the Netherlands; identifier: w22.069). If shown efficacious in improving mental health, as well as physical health, in persons with chronic SCI, the low cost and accessibility of the WHM allows it to be directly implemented in SCI rehabilitation. TRIAL REGISTRATION NUMBER: NCT05704322.