Phase 2/3, randomized, closed, single-blind, three-arm study to evaluate the effect of creatine supplementation and physical activity on long-term COVID-related fatigue: FATIGUE Study

• Grant number: 23/00463-2
• Support Opportunities: Regular Research Grants
• Start date: October 01, 2023
• End date: September 30, 2024
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Robson Aparecido Prudente
• Grantee: Robson Aparecido Prudente
• Host Institution: Hospital das Clínicas da Faculdade de Medicina de Botucatu. Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil
• Associated researchers: Paula Schmidt Azevedo Gaiolla ; Sergio Alberto Rupp de Paiva ; Suzana Erico Tanni

Abstract

The persistence of symptoms after initial manifestations of Covid-19 was denominated long Covid, it is characterized by, among others, fatigue, dyspnea, and muscle pain. Its treatment includes physical exercise, psychological approach, and nutritional treatment and, considering the possible relationship of creatine in situations of chronic fatigue, it is believed that its supplementation could improve the symptoms resulting from this condition. This is possible because irregularities in creatine metabolism in fatigue situations can favor disturbances in body creatine levels and, in this sense, when physical exercise is increased, phosphocreatine concentrations are reduced - with a consequent reduction of ATP, which makes the supply energy inefficient for the continuation of the activity. Thus, creatine supplementation would increase its body concentration, with an increase in the amount of muscle phosphocreatine and greater availability of the substrate to maintain physical exercise and reduce fatigue. Therefore, our hypothesis is that creatine supplementation would improve the symptoms of fatigue related to long Covid and, evaluating the effectiveness of its supplementation in this condition will make possible the development of new treatment strategies increasing the quality of life of these individuals and reducing the impact of Covid-19 on health systems. Methodologically, we intend to evaluate the effectiveness of creatine supplementation in 60 individuals with long Covid, randomly allocated into three distinct groups, each with 20 participants. One group will receive 6g of creatine per day, another will receive 18g per day, and another will receive 6g of maltodextrin per day (placebo). All groups will perform three rehabilitation sessions per week for four weeks and, before starting the rehabilitation protocol and at the end of the four weeks, they will be evaluated through a complete clinical evaluation, laboratory analysis and imaging tests. (AU)