Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-exercise Program (FINEXT-BD Study): Protocol of a Randomized Interventionist Program
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Patient Functionality measured through the scale FAST (4 months)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control (TAU)
patients without any intervention + treatment as usual (TAU)
PE intervention+TAU
Physical exercise (PE) intervention + treatment as usual (TAU)
干预措施: Physical exercise (Other)
结局指标
主要结局
Patient Functionality measured through the scale FAST (4 months)
时间窗: 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.
Patient Functionality measured through the scale GAF (4 months)
时间窗: 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.
Patient Functionality measured through the scale FAST (10 months)
时间窗: 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.
Patient Functionality measured through the scale GAF (10 months)
时间窗: 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.
Patient Functionality measured through the Strauss-Carpenter scale (10) months)
时间窗: 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.
Patient Functionality measured through the Strauss-Carpenter scale (4 months)
时间窗: 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.
次要结局
- TG (4 months)(Change at the end of the training period (4 months))
- HDL (10 months)(Changes after 10 months)
- TrkB-FL (4 months)(Change at the end of the training period (4 months))
- BDNF (10 months)(Changes after 10 months)
- VT1 and VT2 in CPET (4 months)(Change at the end of the training period (4 months))
- TrkB-FL (10 months)(Changes after 10 months)
- TrkB-T (10 months)(Changes after 10 months)
- BDNF (4 months)(Change at the end of the training period (4 months))
- VO2Peak in CPET (10 months)(Changes after 10 months)
- Relative VO2Peak in CPET (4 months)(Change at the end of the training period (4 months))
- METs in CPET (10 months)(Changes after 10 months)
- Relative VO2Peak in CPET (10 months)(Changes after 10 months)
- Oxidative stress (10 months)(Changes after 10 months)
- Height (4 months)(Change at the end of the training period (4 months))
- TrkB-T (4 months)(Change at the end of the training period (4 months))
- METs in CPET (4 months)(Change at the end of the training period (4 months))
- HRpeak in CPET (10 months)(Changes after 10 months)
- OCT Study of the retina by optical tomography (4 months)(Change at the end of the training period (4 months))
- Fat mass (%) (10 months)(Changes after 10 months)
- Presence of depressive symptoms (4 months)(Change at the end of the training period (4 months))
- Presence of depressive symptoms (10 months)(Changes after 10 months)
- VO2Peak in CPET (4 months)(Change at the end of the training period (4 months))
- Appendicular muscle mass (10 months)(Changes after 10 months)
- Manic symptoms using the (YMRS) (4 months)(Change at the end of the training period (4 months))
- Manic symptoms using the (YMRS) (10 months)(Changes after 10 months)
- Glucose (4 months)(Change at the end of the training period (4 months))
- HDL (4 months)(Change at the end of the training period (4 months))
- VT1 and VT2 in CPET(10 months)(Changes after 10 months)
- HRpeak in CPET (4 months)(Change at the end of the training period (4 months))
- Muscle mass (4 months)(Change at the end of the training period (4 months))
- Muscle mass (10 months)(Changes after 10 months)
- Appendicular muscle mass (4months)(Change at the end of the training period (4 months))
- Body mass (10 months)(Changes after 10 months)
- BMI (10 months)(Changes after 10 months)
- TG (10 months)(Changes after 10 months)
- Patient symptom severity measured through the scale CGI (4 months)(Change at the end of the training period (4 months))
- Cognitive functioning measured through WSCT (4 months)(Change at the end of the training period (4 months))
- OCT Study of the retina by optical (10 months)(Changes after 10 months)
- Fat mass (%)(4 months)(Change at the end of the training period (4 months))
- Bone mineral content (4 months)(Changes after 10 months)
- Body mass (4 months)(Change at the end of the training period (4 months))
- Patient symptom severity measured through the scale CGI (10 months)(Changes after 10 months)
- Cognitive functioning measured through WSCT (10 months)(Changes after 10 months)
- Cognitive functioning measured through (SCWT) (10 months)(Changes after 10 months)
- Oxidative stress (4 months)(Change at the end of the training period (4 months))
- Inflammation (4 months)(Change at the end of the training period (4 months))
- Inflammation (10 months)(Changes after 10 months)
- Height (10 months)(Changes after 10 months)
- BMI (4 months)(Change at the end of the training period (4 months))
- Waist circumference (4 months)(Changes after 10 months)
- SBP and DBP (10 months)(Changes after 10 months)
- SBP and DBP (4 months)(Change at the end of the training period (4 months))
- Glucose (10 months)(Changes after 10 months)
- Cognitive functioning measured through CVLT (10 months)(Changes after 10 months)
- Cognitive functioning measured through CVLT (4 months)(Change at the end of the training period (4 months))
- Cognitive functioning measured through (SCWT) (4 months)(Change at the end of the training period (4 months))
- Bone mineral content (4 months)(Change at the end of the training period (4 months))
- Waist circumference (4 months)(Change at the end of the training period (4 months))
研究者
ANA GONZALEZ PINTO
Principal Investigator
Bioaraba Health Research Institute