Clinical trial NCT04400630: Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-exercise Program (FINEXT-BD Study)
Official title: Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Bioaraba Health Research Institute
Sponsor class: NETWORK
First posted: 2020-05-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal, interventional, randomized, controlled, simple-blind clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with bipolar disorder type I according to the criteria of the DSM-5 manual, diagnosis made by structured interview SCID-P.
* The study includes patients with first episode and multiple episodes. At the beginning of the study they must be in euthymia, that is, there will be no current diagnosis of manic, hypomanic or depressive episode. Relapses during follow-up and the presence of subindromial symptoms at any time will not result in exclusion from the study.
* Patients may be treated with any treatment according to clinical guidelines.
* Age: 18-65 years
* Speak Spanish correctly
* Informed consent for the study of the patient

Exclusion Criteria:

* Presence of organic diseases of the central nervous system (CNS) or history of head trauma with loss of consciousness
* Intellectual disability.
* Acute inflammatory disease
* Treatment with anti-inflammatory drugs during the week prior to sample taking
* Pervasive developmental disorders.
* Pregnancy and lactation

Primary outcomes:
measure: Patient Functionality measured through the scale FAST (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Patient Functionality measured through the scale FAST (10 months)
timeFrame: Changes after 10 months
measure: Patient Functionality measured through the scale GAF (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Patient Functionality measured through the scale GAF (10 months)
timeFrame: Changes after 10 months
measure: Patient Functionality measured through the Strauss-Carpenter scale (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Patient Functionality measured through the Strauss-Carpenter scale (10) months)
timeFrame: Changes after 10 months
Secondary outcomes:
measure: TrkB-FL (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: TrkB-FL (10 months)
timeFrame: Changes after 10 months
measure: TrkB-T (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: TrkB-T (10 months)
timeFrame: Changes after 10 months
measure: BDNF (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: BDNF (10 months)
timeFrame: Changes after 10 months
measure: Presence of depressive symptoms (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Presence of depressive symptoms (10 months)
timeFrame: Changes after 10 months
measure: VO2Peak in CPET (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: VO2Peak in CPET (10 months)
timeFrame: Changes after 10 months
measure: Relative VO2Peak in CPET (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Relative VO2Peak in CPET (10 months)
timeFrame: Changes after 10 months
measure: METs in CPET (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: METs in CPET (10 months)
timeFrame: Changes after 10 months
measure: VT1 and VT2 in CPET (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: VT1 and VT2 in CPET(10 months)
timeFrame: Changes after 10 months
measure: HRpeak in CPET (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: HRpeak in CPET (10 months)
timeFrame: Changes after 10 months
measure: OCT Study of the retina by optical tomography (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: OCT Study of the retina by optical (10 months)
timeFrame: Changes after 10 months
measure: Muscle mass (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Muscle mass (10 months)
timeFrame: Changes after 10 months
measure: Fat mass (%)(4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Fat mass (%) (10 months)
timeFrame: Changes after 10 months
measure: Bone mineral content (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Bone mineral content (4 months)
timeFrame: Changes after 10 months
measure: Appendicular muscle mass (4months)
timeFrame: Change at the end of the training period (4 months)
measure: Appendicular muscle mass (10 months)
timeFrame: Changes after 10 months
measure: Oxidative stress (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Oxidative stress (10 months)
timeFrame: Changes after 10 months
measure: Inflammation (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Inflammation (10 months)
timeFrame: Changes after 10 months
measure: Manic symptoms using the (YMRS) (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Manic symptoms using the (YMRS) (10 months)
timeFrame: Changes after 10 months
measure: Body mass (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Body mass (10 months)
timeFrame: Changes after 10 months
measure: Height (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Height (10 months)
timeFrame: Changes after 10 months
measure: BMI (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: BMI (10 months)
timeFrame: Changes after 10 months
measure: Waist circumference (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Waist circumference (4 months)
timeFrame: Changes after 10 months
measure: SBP and DBP (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: SBP and DBP (10 months)
timeFrame: Changes after 10 months
measure: TG (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: TG (10 months)
timeFrame: Changes after 10 months
measure: Glucose (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Glucose (10 months)
timeFrame: Changes after 10 months
measure: HDL (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: HDL (10 months)
timeFrame: Changes after 10 months
measure: Patient symptom severity measured through the scale CGI (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Patient symptom severity measured through the scale CGI (10 months)
timeFrame: Changes after 10 months
measure: Cognitive functioning measured through CVLT (10 months)
timeFrame: Changes after 10 months
measure: Cognitive functioning measured through CVLT (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Cognitive functioning measured through WSCT (10 months)
timeFrame: Changes after 10 months
measure: Cognitive functioning measured through WSCT (4 months)
timeFrame: Change at the end of the training period (4 months)
measure: Cognitive functioning measured through (SCWT) (10 months)
timeFrame: Changes after 10 months
measure: Cognitive functioning measured through (SCWT) (4 months)
timeFrame: Change at the end of the training period (4 months)
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Araba University Hospital
state: Alava
Study officials:
affiliation: BIOARABA HRI
name: Ana María Gonzalez-Pinto
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia S, Gorostegi-Anduaga I, Garcia-Corres E, Maldonado-Martin S, MacDowell KS, Bermudez-Ampudia C, Apodaca MJ, Perez-Landaluce I, Tobalina-Larrea I, Leza JC, Gonzalez-Pinto A. Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-Exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist Program. Front Psychiatry. 2020 Oct 29;11:568455. doi: 10.3389/fpsyt.2020.568455. eCollection 2020.