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Bipolar DisorderFINEXT-BDNCT04400630

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

A study testing Physical exercise in people with Bipolar Disorder, run by Bioaraba Health Research Institute at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Disorder
What is being tested?
Physical exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSpain
Study dates
5 Nov 2019to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ana María Gonzalez-Pinto contact

+34 945007879

anapinto@telefonica.net

Spain1 site, 1 recruiting

  • Araba University Hospital

    Vitoria-Gasteiz, Alava, 01009

    Ana María Gonzalez-Pinto, +34 945007879, anapinto@telefonica.net

    Recruiting

Other trials in Spain

About this 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

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.

Read the 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)

Being tested
Physical exercise
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical exerciseOther

    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.

Study groups in NCT04400630
Study groupRoleWhat they receive
Control (TAU)No interventionpatients without any intervention + treatment as usual (TAU)
PE intervention+TAUExperimentalPhysical exercise (PE) intervention + treatment as usual (TAU)
Receives: Other: Physical exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change at the end of the training period (4 months)

  2. 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.

    Measured: Changes after 10 months

  3. 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.

    Measured: Change at the end of the training period (4 months)

  4. 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.

    Measured: Changes after 10 months

  5. 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.

    Measured: Change at the end of the training period (4 months)

  6. 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.

    Measured: Changes after 10 months

Secondary outcomes (58)

  1. TrkB-FL (4 months)

    Expression of BDNF: TrkB-FL

    Measured: Change at the end of the training period (4 months)

  2. TrkB-FL (10 months)

    Expression of BDNF: TrkB-FL

    Measured: Changes after 10 months

  3. TrkB-T (4 months)

    Expression of BDNF:TrkB-T

    Measured: Change at the end of the training period (4 months)

  4. TrkB-T (10 months)

    Expression of BDNF:TrkB-T

    Measured: Changes after 10 months

  5. BDNF (4 months)

    Peripheral BDNF levels

    Measured: Change at the end of the training period (4 months)

  6. BDNF (10 months)

    Peripheral BDNF levels

    Measured: Changes after 10 months

  7. Presence of depressive symptoms (4 months)

    Hamilton Depression Scale (HDRS-21)

    Measured: Change at the end of the training period (4 months)

  8. Presence of depressive symptoms (10 months)

    Hamilton Depression Scale (HDRS-21)

    Measured: Changes after 10 months

  9. VO2Peak in CPET (4 months)

    Value of VO2Peak (L min-1) in cardiopulmonary exercise test (CPET)

    Measured: Change at the end of the training period (4 months)

  10. VO2Peak in CPET (10 months)

    Value of VO2Peak (L min-1) in cardiopulmonary exercise test (CPET)

    Measured: Changes after 10 months

  11. Relative VO2Peak in CPET (4 months)

    Value of relative VO2Peak (mL kg-1 min-1) in cardiopulmonary exercise test (CPET)

    Measured: Change at the end of the training period (4 months)

  12. Relative VO2Peak in CPET (10 months)

    Value of relative VO2Peak (mL kg-1 min-1) in cardiopulmonary exercise test (CPET)

    Measured: Changes after 10 months

  13. METs in CPET (4 months)

    Value of metabolic equivalents in cardiopulmonary exercise test (CPET)

    Measured: Change at the end of the training period (4 months)

  14. METs in CPET (10 months)

    Value of metabolic equivalents in cardiopulmonary exercise test (CPET)

    Measured: Changes after 10 months

  15. 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)

    Measured: Change at the end of the training period (4 months)

  16. 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)

    Measured: Changes after 10 months

  17. HRpeak in CPET (4 months)

    Value of HRpeak in cardiopulmonary exercise test (CPET)

    Measured: Change at the end of the training period (4 months)

  18. HRpeak in CPET (10 months)

    Value of HRpeak in cardiopulmonary exercise test (CPET)

    Measured: Changes after 10 months

  19. 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.

    Measured: Change at the end of the training period (4 months)

  20. 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.

    Measured: Changes after 10 months

  21. Muscle mass (4 months)

    Anthropometric measures muscle mass (g)

    Measured: Change at the end of the training period (4 months)

  22. Muscle mass (10 months)

    Anthropometric measures muscle mass (g)

    Measured: Changes after 10 months

  23. Fat mass (%)(4 months)

    Anthropometric measures Fat mass (%)

    Measured: Change at the end of the training period (4 months)

  24. Fat mass (%) (10 months)

    Anthropometric measures Fat mass (%)

    Measured: Changes after 10 months

  25. Bone mineral content (4 months)

    Anthropometric measures: Bone mineral density (g/cm^2) shall be determined by Dual Energy X-Ray Absorptiometry (DXA).

    Measured: Change at the end of the training period (4 months)

  26. Bone mineral content (4 months)

    Anthropometric measures: Bone mineral density (g/cm^2) shall be determined by Dual Energy X-Ray Absorptiometry (DXA).

    Measured: Changes after 10 months

  27. 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.

    Measured: Change at the end of the training period (4 months)

  28. 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.

    Measured: Changes after 10 months

  29. Oxidative stress (4 months)

    Oxidative stress: Total Antioxidant Status (TAS), Glutathione peroxidase (GPx) y - Glutathione (GSH), Lipid Peroxidation (TBARS) y Nitrite (NO2)

    Measured: Change at the end of the training period (4 months)

  30. Oxidative stress (10 months)

    Oxidative stress: Total Antioxidant Status (TAS), Glutathione peroxidase (GPx) y - Glutathione (GSH), Lipid Peroxidation (TBARS) y Nitrite (NO2)

    Measured: Changes after 10 months

  31. Inflammation (4 months)

    Cytokine levels: IL6 and prostaglandin Levels PGE2

    Measured: Change at the end of the training period (4 months)

  32. Inflammation (10 months)

    Cytokine levels: IL6 and prostaglandin Levels PGE2

    Measured: Changes after 10 months

  33. 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.

    Measured: Change at the end of the training period (4 months)

  34. 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.

    Measured: Changes after 10 months

  35. Body mass (4 months)

    Physical parameters: Body mass (kg)

    Measured: Change at the end of the training period (4 months)

  36. Body mass (10 months)

    Physical parameters: Body mass (kg)

    Measured: Changes after 10 months

  37. Height (4 months)

    Physical parameters: Height (cm)

    Measured: Change at the end of the training period (4 months)

  38. Height (10 months)

    Physical parameters: Height (cm)

    Measured: Changes after 10 months

  39. BMI (4 months)

    Physical parameters: Body mass index (kg/m2)

    Measured: Change at the end of the training period (4 months)

  40. BMI (10 months)

    Physical parameters: Body mass index (kg/m2)

    Measured: Changes after 10 months

  41. Waist circumference (4 months)

    Physical parameters: Waist circumference (cm)

    Measured: Change at the end of the training period (4 months)

  42. Waist circumference (4 months)

    Physical parameters: Waist circumference (cm)

    Measured: Changes after 10 months

  43. 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

    Measured: Change at the end of the training period (4 months)

  44. 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

    Measured: Changes after 10 months

  45. TG (4 months)

    Physical parameters: Serum levels of triglycerides (mg/dl )

    Measured: Change at the end of the training period (4 months)

  46. TG (10 months)

    Physical parameters: Serum levels of triglycerides (mg/dl )

    Measured: Changes after 10 months

  47. Glucose (4 months)

    Physical parameters: Glucose (mg/dl)

    Measured: Change at the end of the training period (4 months)

  48. Glucose (10 months)

    Physical parameters: Glucose (mg/dl)

    Measured: Changes after 10 months

  49. HDL (4 months)

    Physical parameters: HDL colesterol (mg/dl)

    Measured: Change at the end of the training period (4 months)

  50. HDL (10 months)

    Physical parameters: HDL colesterol (mg/dl)

    Measured: Changes after 10 months

  51. 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).

    Measured: Change at the end of the training period (4 months)

  52. 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).

    Measured: Changes after 10 months

  53. Cognitive functioning measured through CVLT (10 months)

    California Verbal Learning Test

    Measured: Changes after 10 months

  54. Cognitive functioning measured through CVLT (4 months)

    California Verbal Learning Test

    Measured: Change at the end of the training period (4 months)

  55. 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

    Measured: Changes after 10 months

  56. 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

    Measured: Change at the end of the training period (4 months)

  57. 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.

    Measured: Changes after 10 months

  58. 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.

    Measured: Change at the end of the training period (4 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2020
  2. Study start5 Nov 2019
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Longitudinal, interventional, randomized, controlled, simple-blind clinical trial
Masking
Single blind
Who is masked
Investigator
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04400630
Sponsor's protocol ID
FINEX-BD
Acronym
FINEXT-BD
Status last verified
Sep 2020
First submitted
11 May 2020
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 33240125

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercise in people with Bipolar Disorder, run by Bioaraba Health Research Institute at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ana María Gonzalez-Pinto (+34 945007879, anapinto@telefonica.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Functionality measured through the scale FAST (4 months) (time frame: Change at the end of the training period (4 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04400630, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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