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

NCT04400630 | Unknown

• 1 other identifier: FINEX-BD
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (58)

• TrkB-FL (4 months)

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

• TrkB-FL (10 months)

  Changes after 10 months

• TrkB-T (4 months)

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

• TrkB-T (10 months)

  Changes after 10 months

• BDNF (4 months)

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

Study Arms (2)

Control (TAU)

NO INTERVENTION

patients without any intervention + treatment as usual (TAU)

PE intervention+TAU

EXPERIMENTAL

Physical exercise (PE) intervention + treatment as usual (TAU)

Other: Physical exercise

Interventions

Physical exercise OTHER

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.

PE intervention+TAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with bipolar disorder type I according to the criteria of the DSM-5 manual, diagnosis made by structured interview SCID-P.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioaraba Health Research Institute: lead

Study Sites (1)

Araba University Hospital

Vitoria-Gasteiz, Alava, 01009, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 33240125 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ana María Gonzalez-Pinto

  BIOARABA HRI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana María Gonzalez-Pinto

CONTACT

+34 945007879; anapinto@telefonica.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The person in charge of the assessments will not be involved in the treatment program and will be blinded to this process. Study evaluators will be blinded to the treatment branch
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Longitudinal, interventional, randomized, controlled, simple-blind clinical trial

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 22, 2020
• Study Start: November 5, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

ES (1)