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

Bipolar Disorder Clinical Trial

— FINEXT-BD  

Official title:

Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04400630
• Other study ID #: FINEX-BD
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2020
• Source: Bioaraba Health Research Institute
• Contact: Ana María Gonzalez-Pinto
• Phone: +34 945007879
• Email: anapinto[@]telefonica.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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.

Locations

Country	Name	City	State
Spain	Araba University Hospital	Vitoria	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Bioaraba Health Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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	TrkB-FL (4 months)	Expression of BDNF: TrkB-FL	Change at the end of the training period (4 months)
Secondary	TrkB-FL (10 months)	Expression of BDNF: TrkB-FL	Changes after 10 months
Secondary	TrkB-T (4 months)	Expression of BDNF:TrkB-T	Change at the end of the training period (4 months)
Secondary	TrkB-T (10 months)	Expression of BDNF:TrkB-T	Changes after 10 months
Secondary	BDNF (4 months)	Peripheral BDNF levels	Change at the end of the training period (4 months)
Secondary	BDNF (10 months)	Peripheral BDNF levels	Changes after 10 months
Secondary	Presence of depressive symptoms (4 months)	Hamilton Depression Scale (HDRS-21)	Change at the end of the training period (4 months)
Secondary	Presence of depressive symptoms (10 months)	Hamilton Depression Scale (HDRS-21)	Changes after 10 months
Secondary	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)
Secondary	VO2Peak in CPET (10 months)	Value of VO2Peak (L min-1) in cardiopulmonary exercise test (CPET)	Changes after 10 months
Secondary	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)
Secondary	Relative VO2Peak in CPET (10 months)	Value of relative VO2Peak (mL kg-1 min-1) in cardiopulmonary exercise test (CPET)	Changes after 10 months
Secondary	METs in CPET (4 months)	Value of metabolic equivalents in cardiopulmonary exercise test (CPET)	Change at the end of the training period (4 months)
Secondary	METs in CPET (10 months)	Value of metabolic equivalents in cardiopulmonary exercise test (CPET)	Changes after 10 months
Secondary	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)
Secondary	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
Secondary	HRpeak in CPET (4 months)	Value of HRpeak in cardiopulmonary exercise test (CPET)	Change at the end of the training period (4 months)
Secondary	HRpeak in CPET (10 months)	Value of HRpeak in cardiopulmonary exercise test (CPET)	Changes after 10 months
Secondary	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)
Secondary	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
Secondary	Muscle mass (4 months)	Anthropometric measures muscle mass (g)	Change at the end of the training period (4 months)
Secondary	Muscle mass (10 months)	Anthropometric measures muscle mass (g)	Changes after 10 months
Secondary	Fat mass (%)(4 months)	Anthropometric measures Fat mass (%)	Change at the end of the training period (4 months)
Secondary	Fat mass (%) (10 months)	Anthropometric measures Fat mass (%)	Changes after 10 months
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	Inflammation (4 months)	Cytokine levels: IL6 and prostaglandin Levels PGE2	Change at the end of the training period (4 months)
Secondary	Inflammation (10 months)	Cytokine levels: IL6 and prostaglandin Levels PGE2	Changes after 10 months
Secondary	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)
Secondary	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
Secondary	Body mass (4 months)	Physical parameters: Body mass (kg)	Change at the end of the training period (4 months)
Secondary	Body mass (10 months)	Physical parameters: Body mass (kg)	Changes after 10 months
Secondary	Height (4 months)	Physical parameters: Height (cm)	Change at the end of the training period (4 months)
Secondary	Height (10 months)	Physical parameters: Height (cm)	Changes after 10 months
Secondary	BMI (4 months)	Physical parameters: Body mass index (kg/m2)	Change at the end of the training period (4 months)
Secondary	BMI (10 months)	Physical parameters: Body mass index (kg/m2)	Changes after 10 months
Secondary	Waist circumference (4 months)	Physical parameters: Waist circumference (cm)	Change at the end of the training period (4 months)
Secondary	Waist circumference (4 months)	Physical parameters: Waist circumference (cm)	Changes after 10 months
Secondary	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)
Secondary	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
Secondary	TG (4 months)	Physical parameters: Serum levels of triglycerides (mg/dl )	Change at the end of the training period (4 months)
Secondary	TG (10 months)	Physical parameters: Serum levels of triglycerides (mg/dl )	Changes after 10 months
Secondary	Glucose (4 months)	Physical parameters: Glucose (mg/dl)	Change at the end of the training period (4 months)
Secondary	Glucose (10 months)	Physical parameters: Glucose (mg/dl)	Changes after 10 months
Secondary	HDL (4 months)	Physical parameters: HDL colesterol (mg/dl)	Change at the end of the training period (4 months)
Secondary	HDL (10 months)	Physical parameters: HDL colesterol (mg/dl)	Changes after 10 months
Secondary	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)
Secondary	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
Secondary	Cognitive functioning measured through CVLT (10 months)	California Verbal Learning Test	Changes after 10 months
Secondary	Cognitive functioning measured through CVLT (4 months)	California Verbal Learning Test	Change at the end of the training period (4 months)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)