Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-exercise Program (FINEXT-BD Study) (FINEXT-BD)

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.

Study Overview

• Status: Unknown
• Conditions: Bipolar Disorder
• Intervention / Treatment: Other: Physical exercise

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)

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alava
    • Vitoria, Alava, Spain, 01009
      • Recruiting
      • Araba University Hospital
      • Contact: Ana María Gonzalez-Pinto; Phone Number: +34 945007879; Email: anapinto@telefonica.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (TAU); patients without any intervention + treatment as usual (TAU)
Experimental: PE intervention+TAU; Physical exercise (PE) intervention + treatment as usual (TAU)	Other: Physical exercise; The experimental group will receive supervised physical exercise treatment by high-intensity interval training (HIT), alternating high and moderate intensities (20 min). The participants will exercise two non-consecutive days per week for 16 weeks under supervision by exercise specialists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Functionality measured through the scale FAST (4 months)	The Functioning Assessment Short Test is a brief instrument designed to assess functional impairment in severe mental disorders. The 24 items of the scale cover six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time.	Change at the end of the training period (4 months)
Patient Functionality measured through the scale FAST (10 months)	The Functioning Assessment Short Test is a brief instrument designed to assess functional impairment in severe mental disorders. The 24 items of the scale cover six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time.	Changes after 10 months
Patient Functionality measured through the scale GAF (4 months)	Global Assessment of Functioning (GAF):This scale evaluates with a score from 0 to 100 the level of functioning and the severity of the patient's symptoms, the higher values corresponding to better overall functionality.	Change at the end of the training period (4 months)
Patient Functionality measured through the scale GAF (10 months)	Global Assessment of Functioning (GAF):This scale evaluates with a score from 0 to 100 the level of functioning and the severity of the patient's symptoms, the higher values corresponding to better overall functionality.	Changes after 10 months
Patient Functionality measured through the Strauss-Carpenter scale (4 months)	Strauss-Carpenter scale consists of four items rated from 0 to 4 on a Likert-type scale and yields a total score that is calculated by the addition of all item scores: the higher the score, the better is the prognosis.	Change at the end of the training period (4 months)
Patient Functionality measured through the Strauss-Carpenter scale (10) months)	Strauss-Carpenter scale consists of four items rated from 0 to 4 on a Likert-type scale and yields a total score that is calculated by the addition of all item scores: the higher the score, the better is the prognosis.	Changes after 10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TrkB-FL (4 months)	Expression of BDNF: TrkB-FL	Change at the end of the training period (4 months)
TrkB-FL (10 months)	Expression of BDNF: TrkB-FL	Changes after 10 months
TrkB-T (4 months)	Expression of BDNF:TrkB-T	Change at the end of the training period (4 months)
TrkB-T (10 months)	Expression of BDNF:TrkB-T	Changes after 10 months
BDNF (4 months)	Peripheral BDNF levels	Change at the end of the training period (4 months)
BDNF (10 months)	Peripheral BDNF levels	Changes after 10 months
Presence of depressive symptoms (4 months)	Hamilton Depression Scale (HDRS-21)	Change at the end of the training period (4 months)
Presence of depressive symptoms (10 months)	Hamilton Depression Scale (HDRS-21)	Changes after 10 months
VO2Peak in CPET (4 months)	Value of VO2Peak (L min-1) in cardiopulmonary exercise test (CPET)	Change at the end of the training period (4 months)
VO2Peak in CPET (10 months)	Value of VO2Peak (L min-1) in cardiopulmonary exercise test (CPET)	Changes after 10 months
Relative VO2Peak in CPET (4 months)	Value of relative VO2Peak (mL kg-1 min-1) in cardiopulmonary exercise test (CPET)	Change at the end of the training period (4 months)
Relative VO2Peak in CPET (10 months)	Value of relative VO2Peak (mL kg-1 min-1) in cardiopulmonary exercise test (CPET)	Changes after 10 months
METs in CPET (4 months)	Value of metabolic equivalents in cardiopulmonary exercise test (CPET)	Change at the end of the training period (4 months)
METs in CPET (10 months)	Value of metabolic equivalents in cardiopulmonary exercise test (CPET)	Changes after 10 months
VT1 and VT2 in CPET (4 months)	Value of first and second ventilatory threshold (VT1 and VT2)(mL kg-1 min-1) metabolic equivalents in cardiopulmonary exercise test (CPET)	Change at the end of the training period (4 months)
VT1 and VT2 in CPET(10 months)	Value of first and second ventilatory threshold (VT1 and VT2)(mL kg-1 min-1) metabolic equivalents in cardiopulmonary exercise test (CPET)	Changes after 10 months
HRpeak in CPET (4 months)	Value of HRpeak in cardiopulmonary exercise test (CPET)	Change at the end of the training period (4 months)
HRpeak in CPET (10 months)	Value of HRpeak in cardiopulmonary exercise test (CPET)	Changes after 10 months
OCT Study of the retina by optical tomography (4 months)	RFNL, GCL and IPL thickness in the two eyes, with each layer divided into segments: overall, temporal, nasal, superior and inferior.	Change at the end of the training period (4 months)
OCT Study of the retina by optical (10 months)	RFNL, GCL and IPL thickness in the two eyes, with each layer divided into segments: overall, temporal, nasal, superior and inferior.	Changes after 10 months
Muscle mass (4 months)	Anthropometric measures muscle mass (g)	Change at the end of the training period (4 months)
Muscle mass (10 months)	Anthropometric measures muscle mass (g)	Changes after 10 months
Fat mass (%)(4 months)	Anthropometric measures Fat mass (%)	Change at the end of the training period (4 months)
Fat mass (%) (10 months)	Anthropometric measures Fat mass (%)	Changes after 10 months
Bone mineral content (4 months)	Anthropometric measures: Bone mineral density (g/cm^2) shall be determined by Dual Energy X-Ray Absorptiometry (DXA).	Change at the end of the training period (4 months)
Bone mineral content (4 months)	Anthropometric measures: Bone mineral density (g/cm^2) shall be determined by Dual Energy X-Ray Absorptiometry (DXA).	Changes after 10 months
Appendicular muscle mass (4months)	Anthropometric measures: appendicular muscle mass (g) will also be determined by adding up the muscle mass of both arms and legs.	Change at the end of the training period (4 months)
Appendicular muscle mass (10 months)	Anthropometric measures: appendicular muscle mass (g) will also be determined by adding up the muscle mass of both arms and legs.	Changes after 10 months
Oxidative stress (4 months)	Oxidative stress: Total Antioxidant Status (TAS), Glutathione peroxidase (GPx) y - Glutathione (GSH), Lipid Peroxidation (TBARS) y Nitrite (NO2)	Change at the end of the training period (4 months)
Oxidative stress (10 months)	Oxidative stress: Total Antioxidant Status (TAS), Glutathione peroxidase (GPx) y - Glutathione (GSH), Lipid Peroxidation (TBARS) y Nitrite (NO2)	Changes after 10 months
Inflammation (4 months)	Cytokine levels: IL6 and prostaglandin Levels PGE2	Change at the end of the training period (4 months)
Inflammation (10 months)	Cytokine levels: IL6 and prostaglandin Levels PGE2	Changes after 10 months
Manic symptoms using the (YMRS) (4 months)	Young Mania Rating Scale (YMRS): The total score ranges from 0-60, with the status of euthymia being classified as getting 6 or fewer points, hypomania as getting 12 or more points, and mania as getting between 20 and 60 points.	Change at the end of the training period (4 months)
Manic symptoms using the (YMRS) (10 months)	Young Mania Rating Scale (YMRS): The total score ranges from 0-60, with the status of euthymia being classified as getting 6 or fewer points, hypomania as getting 12 or more points, and mania as getting between 20 and 60 points.	Changes after 10 months
Body mass (4 months)	Physical parameters: Body mass (kg)	Change at the end of the training period (4 months)
Body mass (10 months)	Physical parameters: Body mass (kg)	Changes after 10 months
Height (4 months)	Physical parameters: Height (cm)	Change at the end of the training period (4 months)
Height (10 months)	Physical parameters: Height (cm)	Changes after 10 months
BMI (4 months)	Physical parameters: Body mass index (kg/m2)	Change at the end of the training period (4 months)
BMI (10 months)	Physical parameters: Body mass index (kg/m2)	Changes after 10 months
Waist circumference (4 months)	Physical parameters: Waist circumference (cm)	Change at the end of the training period (4 months)
Waist circumference (4 months)	Physical parameters: Waist circumference (cm)	Changes after 10 months
SBP and DBP (4 months)	Physical parameters: Systolic and diastolic blood pressure (mm Hg) measured taken from the right arm in a seated and relaxed position by using a life-support monitor	Change at the end of the training period (4 months)
SBP and DBP (10 months)	Physical parameters: Systolic and diastolic blood pressure (mm Hg) measured taken from the right arm in a seated and relaxed position by using a life-support monitor	Changes after 10 months
TG (4 months)	Physical parameters: Serum levels of triglycerides (mg/dl )	Change at the end of the training period (4 months)
TG (10 months)	Physical parameters: Serum levels of triglycerides (mg/dl )	Changes after 10 months
Glucose (4 months)	Physical parameters: Glucose (mg/dl)	Change at the end of the training period (4 months)
Glucose (10 months)	Physical parameters: Glucose (mg/dl)	Changes after 10 months
HDL (4 months)	Physical parameters: HDL colesterol (mg/dl)	Change at the end of the training period (4 months)
HDL (10 months)	Physical parameters: HDL colesterol (mg/dl)	Changes after 10 months
Patient symptom severity measured through the scale CGI (4 months)	The Clinical Global Impression Scale (CGI): consists of two subscales. Each subscale has a single item scored between 0, not evaluated, to 7 which corresponds to the maximum severity (severity subscale) or to a state of no improvement and aggravated worsening of the symptomatology (improvement subscale).	Change at the end of the training period (4 months)
Patient symptom severity measured through the scale CGI (10 months)	The Clinical Global Impression Scale (CGI): consists of two subscales. Each subscale has a single item scored between 0, not evaluated, to 7 which corresponds to the maximum severity (severity subscale) or to a state of no improvement and aggravated worsening of the symptomatology (improvement subscale).	Changes after 10 months
Cognitive functioning measured through CVLT (10 months)	California Verbal Learning Test	Changes after 10 months
Cognitive functioning measured through CVLT (4 months)	California Verbal Learning Test	Change at the end of the training period (4 months)
Cognitive functioning measured through WSCT (10 months)	Computerized version of Wisconsin Card Sorting Test: This test consists of cards depicting simple geometric figures that vary in color, shape, and number. Examinees must sort cards in accordance with one of three viable rules, i.e., according to the color, shape, or number of the depicted objects	Changes after 10 months
Cognitive functioning measured through WSCT (4 months)	Computerized version of Wisconsin Card Sorting Test: This test consists of cards depicting simple geometric figures that vary in color, shape, and number. Examinees must sort cards in accordance with one of three viable rules, i.e., according to the color, shape, or number of the depicted objects	Change at the end of the training period (4 months)
Cognitive functioning measured through (SCWT) (10 months)	The Stroop Color and Word Test: Individuals are required to read three different tables as fast as possible. Two of them represent the "congruous condition" in which participants are required to read names of colors (color-words) printed in black ink (W) and name different color patches (C). Conversely, in the third table, named color-word (CW) condition, color-words are printed in an inconsistent color ink.	Changes after 10 months
Cognitive functioning measured through (SCWT) (4 months)	The Stroop Color and Word Test: Individuals are required to read three different tables as fast as possible. Two of them represent the "congruous condition" in which participants are required to read names of colors (color-words) printed in black ink (W) and name different color patches (C). Conversely, in the third table, named color-word (CW) condition, color-words are printed in an inconsistent color ink.	Change at the end of the training period (4 months)

Collaborators and Investigators

• Sponsor: Bioaraba Health Research Institute
• Investigators: Principal Investigator: Ana María Gonzalez-Pinto, BIOARABA HRI

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: FINEX-BD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No