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

September 14, 2020 updated by: ANA GONZALEZ PINTO, Bioaraba Health Research Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Alava
      • Vitoria, Alava, Spain, 01009
        • Recruiting
        • Araba University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient Functionality measured through the scale FAST (4 months)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 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)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 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)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TrkB-FL (4 months)
Time Frame: Change at the end of the training period (4 months)
Expression of BDNF: TrkB-FL
Change at the end of the training period (4 months)
TrkB-FL (10 months)
Time Frame: Changes after 10 months
Expression of BDNF: TrkB-FL
Changes after 10 months
TrkB-T (4 months)
Time Frame: Change at the end of the training period (4 months)
Expression of BDNF:TrkB-T
Change at the end of the training period (4 months)
TrkB-T (10 months)
Time Frame: Changes after 10 months
Expression of BDNF:TrkB-T
Changes after 10 months
BDNF (4 months)
Time Frame: Change at the end of the training period (4 months)
Peripheral BDNF levels
Change at the end of the training period (4 months)
BDNF (10 months)
Time Frame: Changes after 10 months
Peripheral BDNF levels
Changes after 10 months
Presence of depressive symptoms (4 months)
Time Frame: Change at the end of the training period (4 months)
Hamilton Depression Scale (HDRS-21)
Change at the end of the training period (4 months)
Presence of depressive symptoms (10 months)
Time Frame: Changes after 10 months
Hamilton Depression Scale (HDRS-21)
Changes after 10 months
VO2Peak in CPET (4 months)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 10 months
Value of VO2Peak (L min-1) in cardiopulmonary exercise test (CPET)
Changes after 10 months
Relative VO2Peak in CPET (4 months)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 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)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 10 months
Value of metabolic equivalents in cardiopulmonary exercise test (CPET)
Changes after 10 months
VT1 and VT2 in CPET (4 months)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 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)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 10 months
Value of HRpeak in cardiopulmonary exercise test (CPET)
Changes after 10 months
OCT Study of the retina by optical tomography (4 months)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 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)
Time Frame: Change at the end of the training period (4 months)
Anthropometric measures muscle mass (g)
Change at the end of the training period (4 months)
Muscle mass (10 months)
Time Frame: Changes after 10 months
Anthropometric measures muscle mass (g)
Changes after 10 months
Fat mass (%)(4 months)
Time Frame: Change at the end of the training period (4 months)
Anthropometric measures Fat mass (%)
Change at the end of the training period (4 months)
Fat mass (%) (10 months)
Time Frame: Changes after 10 months
Anthropometric measures Fat mass (%)
Changes after 10 months
Bone mineral content (4 months)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 10 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)
Time Frame: Change at the end of the training period (4 months)
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)
Time Frame: Changes after 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)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 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)
Time Frame: Change at the end of the training period (4 months)
Cytokine levels: IL6 and prostaglandin Levels PGE2
Change at the end of the training period (4 months)
Inflammation (10 months)
Time Frame: Changes after 10 months
Cytokine levels: IL6 and prostaglandin Levels PGE2
Changes after 10 months
Manic symptoms using the (YMRS) (4 months)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 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)
Time Frame: Change at the end of the training period (4 months)
Physical parameters: Body mass (kg)
Change at the end of the training period (4 months)
Body mass (10 months)
Time Frame: Changes after 10 months
Physical parameters: Body mass (kg)
Changes after 10 months
Height (4 months)
Time Frame: Change at the end of the training period (4 months)
Physical parameters: Height (cm)
Change at the end of the training period (4 months)
Height (10 months)
Time Frame: Changes after 10 months
Physical parameters: Height (cm)
Changes after 10 months
BMI (4 months)
Time Frame: Change at the end of the training period (4 months)
Physical parameters: Body mass index (kg/m2)
Change at the end of the training period (4 months)
BMI (10 months)
Time Frame: Changes after 10 months
Physical parameters: Body mass index (kg/m2)
Changes after 10 months
Waist circumference (4 months)
Time Frame: Change at the end of the training period (4 months)
Physical parameters: Waist circumference (cm)
Change at the end of the training period (4 months)
Waist circumference (4 months)
Time Frame: Changes after 10 months
Physical parameters: Waist circumference (cm)
Changes after 10 months
SBP and DBP (4 months)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 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)
Time Frame: Change at the end of the training period (4 months)
Physical parameters: Serum levels of triglycerides (mg/dl )
Change at the end of the training period (4 months)
TG (10 months)
Time Frame: Changes after 10 months
Physical parameters: Serum levels of triglycerides (mg/dl )
Changes after 10 months
Glucose (4 months)
Time Frame: Change at the end of the training period (4 months)
Physical parameters: Glucose (mg/dl)
Change at the end of the training period (4 months)
Glucose (10 months)
Time Frame: Changes after 10 months
Physical parameters: Glucose (mg/dl)
Changes after 10 months
HDL (4 months)
Time Frame: Change at the end of the training period (4 months)
Physical parameters: HDL colesterol (mg/dl)
Change at the end of the training period (4 months)
HDL (10 months)
Time Frame: Changes after 10 months
Physical parameters: HDL colesterol (mg/dl)
Changes after 10 months
Patient symptom severity measured through the scale CGI (4 months)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 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)
Time Frame: Changes after 10 months
California Verbal Learning Test
Changes after 10 months
Cognitive functioning measured through CVLT (4 months)
Time Frame: Change at the end of the training period (4 months)
California Verbal Learning Test
Change at the end of the training period (4 months)
Cognitive functioning measured through WSCT (10 months)
Time Frame: Changes after 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)
Time Frame: Change at the end of the training period (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)
Time Frame: Changes after 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)
Time Frame: Change at the end of the training period (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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bioaraba Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ana María Gonzalez-Pinto, BIOARABA HRI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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