Contemporary clinical trials · 2024
Effects of a motor and cognitive training program on executive function and different biomarkers related to muscle-brain crosstalk in breast cancer survivors: 3-arm randomised controlled BRAINonFIT study protocol.
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Orellana-Jaén Jesus, Mora-Fernández Matilde, Carrasco-Páez Luis
Аннотация
INTRODUCTION: Cancer-related cognitive impairment (CRCI) is a significant but often neglected issue for breast cancer survivors that reduces their quality of life. Physical exercise and cognitive training have emerged as promising strategies for CRCI; however, evidence regarding its effectiveness is still unknown. A recently developed motor-cognitive training (dual-tasks) is proposed to examine its efficacy on executive function, physical fitness, emotional symptomatology, and important muscle-brain crosstalk biomarkers.
METHODS: The BRAINonFIT study is a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks). Breast cancer survivors (stage I-IIIA) with completed chemotherapy are recruited from QuirónSalud Hospital in Seville. Principal outcomes are executive functions, measured by the Trail Making Test, Stroop and Digit Span Backwards; physical fitness, assessed by muscle strength, cardiorespiratory fitness, and body composition; and several muscle-brain biomarkers analysed by immunoenzymatic assay (ELISA). Secondary endpoints are memory function, intelligence, learning ability, self-reported cognitive function, and emotional symptomatology. Assessments take place after the enrolment (baseline; T1), after completing the interventions (5 months after baseline; T2), and after completing the follow-up period (8 months after baseline; T3).
DISCUSSION: Given the importance of improving care for breast cancer survivors, this study will provide preliminary evidence for the effectiveness of cognitive-motor training (dual task) as a therapeutic strategy to improve CRCI. Moreover, addressing muscle-brain crosstalk by representative biomarkers will help to elucidate the underlying mechanisms by which this intervention may beneficially impact CRCI.
CLINICALTRIALS: gov: NCT06073717.
METHODS: The BRAINonFIT study is a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks). Breast cancer survivors (stage I-IIIA) with completed chemotherapy are recruited from QuirónSalud Hospital in Seville. Principal outcomes are executive functions, measured by the Trail Making Test, Stroop and Digit Span Backwards; physical fitness, assessed by muscle strength, cardiorespiratory fitness, and body composition; and several muscle-brain biomarkers analysed by immunoenzymatic assay (ELISA). Secondary endpoints are memory function, intelligence, learning ability, self-reported cognitive function, and emotional symptomatology. Assessments take place after the enrolment (baseline; T1), after completing the interventions (5 months after baseline; T2), and after completing the follow-up period (8 months after baseline; T3).
DISCUSSION: Given the importance of improving care for breast cancer survivors, this study will provide preliminary evidence for the effectiveness of cognitive-motor training (dual task) as a therapeutic strategy to improve CRCI. Moreover, addressing muscle-brain crosstalk by representative biomarkers will help to elucidate the underlying mechanisms by which this intervention may beneficially impact CRCI.
CLINICALTRIALS: gov: NCT06073717.