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

NCT ID: NCT04400630

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2022-12-31

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.

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)

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control (TAU)

patients without any intervention + treatment as usual (TAU)

Group Type: NO_INTERVENTION

No interventions assigned to this group

PE intervention+TAU

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

Group Type: EXPERIMENTAL

Physical exercise

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioaraba Health Research Institute

NETWORK

Sponsor Role: lead

Responsible Party

ANA GONZALEZ PINTO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana María Gonzalez-Pinto

Role: PRINCIPAL_INVESTIGATOR

BIOARABA HRI

Locations

Araba University Hospital

Vitoria-Gasteiz, Alava, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Ana María Gonzalez-Pinto

Role: CONTACT

anapinto@telefonica.net

+34 945007879

Facility Contacts

Ana María Gonzalez-Pinto

Role: primary

anapinto@telefonica.net

+34 945007879

References

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.

Reference Type: DERIVED

PMID: 33240125 (View on PubMed)

Other Identifiers

FINEX-BD

Identifier Type: -

Identifier Source: org_study_id