Bipolar Disorder Clinical Trial
Official title:
Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist Program
This is a study that aimed to deep in the physiopathology of BD and see how, through potential modifiable areas of the patients' lifestyle, the prognosis and evolution of the pathology can be improved.
Randomized interventionist study (ratio 1:1) with two parallel branches, blinded by
evaluators (the evaluator does not know the branch of treatment to which the patient belongs
)to evaluate if an individualized moderate-to-vigorous physical exercise intensity program as
adjuvant therapy to standard drug therapy will improve the functional and neuropsychological
status of patients with Bipolar Disorder. The effectiveness of the intervention will be
assessed by an extensive battery of clinical tests, physical parameters (e.g. brain structure
changes measured by optical coherence tomography) and biological parameters (inflammation,
oxidative stress and neurotrophic factors).
The total sample of the study will be 80 patients and a sample of 40 controls (individuals
without psychiatric pathology). The sample of patients will be divided into 40 patients in
each group at random. In the intervention group, a supervised physical exercise treatment by
high-intensity interval training (HIT) will be performed during 16 weeks with 2 sessions per
week (32 sessions in total).Three visits will be made in both groups: baseline visit at the
beginning of the study, at 4 months (at the end of the intervention) and at 10 months (6
months after the end of the intervention)
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