Pilot study protocol of a randomized controlled trial for the potential effects of creatine monohydrate on persistent post-concussive symptoms
Bødker RL, Marcussen M
Frontiers in neurology · 2 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (clasificado por nuestro filtro de IA)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
Según la declaración de financiación del texto completo.
Publicación
- Publicado
- 2023-07-05 · Front Neurol · vol. 14 · pág. 1209548
- Editorial
- Frontiers Media
- Citado
- 4 citas · más que el 69% de estudios similares · 0.7× el promedio de su campo
- Referencias
- 43 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Traumatic Brain Injury Research · Muscle metabolism and nutrition · Thermoregulation and physiological responses
- Palabras clave
- Randomized controlled trial, Medicine, Protocol (science), Creatine, Physical therapy, Physical medicine and rehabilitation, Internal medicine, Alternative medicine, Pathology
2 autores
- Ronni Lykke Bødker🇩🇰 · autor de correspondenciaUniversity of Southern Denmark
- Michael Marcussen🇩🇰University of Southern Denmark; Psychiatry Region Zealand
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Mild traumatic brain injury or concussion is a global public concern, with an estimated annual incidence between 48 million and 96 million worldwide. It is a socioeconomical problem, and almost one-third of individuals with concussion suffer from severe persistent post-concussive symptoms (PPCS), with an increased risk of unemployment or terminating their studies. To date, no single treatment is available with guaranteed success. Creatine monohydrate (CrM) has shown potential as a treatment for post-concussive symptoms, having a positive impact on cognitive function, chronic fatigue, depression, and anxiety. The aim of this study is to examine the effect of CrM on PPCS assessed using the Rivermead Post-Concussion Symptoms Questionnaire (RPQ).
Methods
The study is designed as a double-blinded randomised controlled trial. Study participants are found through neurological outpatient clinics in Denmark or through social media. They will be between 25 and 35 years of age, will have suffered from PPCS for 6-12 months prior to inclusion, and will have no comorbidities. The participants will be randomly allocated to either an intervention group (INT), placebo group (PLA), or control group (CG). Baseline data will be collected immediately after inclusion, and the study period will be 7 weeks. Follow-up data will be collected 1 week after the end of the study period. The primary outcome of the study is changes in RPQ score. Changes in weight and training status will be adjusted for as potential confounders.
Ethics and dissemination
This protocol is approved by the National Committee on Health Research (97508) and by the Danish Data Protection Agency 11.651. The investigators intend to submit their study findings for publication in peer-reviewed journals and disseminate the findings via presentation at academic meetings/conferences.Clinical Trial registration: NCT05562232, registered September 30, 2022.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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