Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder: a Controlled and Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Respiratory gas exchange analysis (ergospirometric)
研究概览
简要总结
The goal of this clinical trial is to evaluate the impact of Physical Exercise (PE), as an adjuvant treatment, on the cognition of patients diagnosed with Bipolar Disorder who present cognitive impairments, as well as its impact on quality of life and functionality and its association with physiological variables.
Our specific goals are:
- Evaluate the effect of PE on the neuropsychological functions of attention, memory, verbal fluency, executive function and processing speed in patients diagnosed with BD who present cognitive impairments in these domains.
- To evaluate the effect of PE on the quality of life and functionality of patients diagnosed with BD, as well as possible associations with cognitive functions.
- To evaluate possible correlations between physiological variables, such as cardiorespiratory indices, strength and body composition, and improvements in cognitive functions, quality of life and functionality.
详细描述
The study aims to assess the impact of structured physical exercise on the cognitive function of bipolar disorder patients presenting deficits, while investigating its association to quality of life and functionality. The study will include 72 euthymic BD patients from the Bipolar Disorder Research Program (PROMAN) at the Institute of Psychiatry of the University of São Paulo Medical School, randomly distributed into two groups: 1) the experimental group will be submitted to supervised training sessions, three times per week, for 12 weeks, including aerobics and strength exercises, as well as treatment as usual (TAU); and 2) the control group will be submitted exclusively to TAU. Cognitive function, depressive and manic symptoms, quality of life and functionality will be assessed at baseline and at follow-uo (week 12), for both groups. Statistical hypothesis testing, assessing the presence of statistically significant differences between groups, pre and post intervention, should be available on the third quarter of 2025.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Bipolar disorder (BD) I and II according to DSM-5
- •Age: 18 - 55 years old
- •Complete primary education
- •Euthymic (YMRS < 8 and MADRS < 12)
- •Presence of cognitive impairments (COBRA > 14 and SCIP < 75)
- •Estimated IQ ≥ 80
- •No medication changes in the last month
- •Having been without regular PE practice for six months
- •Signature of the TCLE
排除标准
- •Organic mental disorder
- •BMI > 40
- •Alcohol or drug abuse in the last 6 months
- •Use of benzodiazepines or beta-blockers in the last month
研究组 & 干预措施
Control Group
the control group will be submitted exclusively to treatment as usual (TAU)
Intervention Group
The experimental group will be submitted to supervised training sessions, three times per week, for 12 weeks, of aerobics exercises, as well as treatment as usual (TAU)
干预措施: Physical Exercise (Other)
结局指标
主要结局
Respiratory gas exchange analysis (ergospirometric)
时间窗: Baseline and Follow-up (12 weeks)
A computerized gas exchange analysis system will be used (CPX/ULTIMA, Medgraphics®, Saint Paul, MN, USA)
Wechsler Abbreviated Scale of Intelligence (WASI)
时间窗: Baseline and Follow-up (12 weeks)
delivers an estimation of a student's general intellectual ability by measuring the verbal, nonverbal, and general cognition of individuals from 6 to 89 years of age.
Digit Span Memory Test
时间窗: Baseline and Follow-up (12 weeks)
short test that evaluates a person's memory and cognitive status
Logical Memory I and II (Wechsler, 1997b)
时间窗: Baseline and Follow-up (12 weeks)
Assessing verbal memory
Stress test on the treadmill
时间窗: Baseline and Follow-up (12 weeks)
A treadmill stress test will be performed.
Anthropometric measurements (skinfolds) and calculation of body composition
时间窗: Baseline and Follow-up (12 weeks)
Body mass (BM) will be measured on a Filizola mechanical scale, with an accuracy of 0.1 kg. Height will be determined using a stadiometer, attached to the scale, with an accuracy of 0.1cm (Gordon et al., 1988). Body composition will be determined using the skinfold thickness technique.
Trail Making Test (Spreen and Strauss, 1998)
时间窗: Baseline and Follow-up (12 weeks)
Assessing alternating attention
One Repetition Maximum Test (1RM)
时间窗: Baseline and Follow-up (12 weeks)
The exercises to be tested are the seated bench press (pectoral muscles), leg-press (quadriceps and glutes), rowing (dorsal muscles), standing knee bending chair (hamstrings), abdominal (rectus and abdominal obliques).
Young Mania Rating Scale (YMRS)
时间窗: Baseline, Week 4, Week 8 and Follow-up (12 weeks)
Scale used to assess the presence and intensity of manic symptoms.
Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA)
时间窗: Baseline only
Screening scale for the presence of cognitive deficits. Suggested cutoff point is 14
Stroop Color-Word Test (Spreen and Strauss, 1998)
时间窗: Baseline and Follow-up (12 weeks)
Assessing mental flexibility and inhibitory control (attention and executive function)
Verbal Fluency - F.A.S (Spreen and Strauss, 1998)
时间窗: Baseline and Follow-up (12 weeks)
Assessing verbal fluency, inhibitory control and the correct use of strategies (executive function)
List of Words (Wechsler, 1997a)
时间窗: Baseline and Follow-up (12 weeks)
Assessing learning capacity and attention
Isokinetic Strength Test
时间窗: Baseline and Follow-up (12 weeks)
The isokinetic test will be performed on the lower limbs (extensor and flexor muscles of the knee joints) on the dominant (R) and non-dominant (ND) leg at an angular velocity of 60 s -1 using a computerized isokinetic dynamometer (Biodex®, Inc . USA).
Body composition by bioimpedance
时间窗: Baseline and Follow-up (12 weeks)
Body composition measurements will be obtained by the non-invasive indirect bioimpedance method using a scale
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Baseline, Week 4, Week 8 and Follow-up (12 weeks)
Scale used to assess the presence and intensity of depressive symptoms.
Screen for Cognitive Impairment in Psychiatry (SCIP)
时间窗: Baseline only
Subjective screening scale for difficulties associated with cognitive impairment. Suggested cutoff point is 70
Cardiovascular evaluation
时间窗: Baseline and Follow-up (12 weeks)
All patients will undergo an electrocardiogram computerized.
Cognitive Emotion Regulation Questionnaire (CERQ)
时间窗: Baseline and Follow-up (12 weeks)
Questionnaire measuring cognitive coping strategies
Difficulties in Emotion Regulation Scale (DERS)
时间窗: Baseline and Follow-up (12 weeks)
Instrument measuring emotion regulation problems
次要结局
- Functional Assessment Staging Tool (FAST)(Baseline and Follow-up (12 weeks))
- The World Health Organization Quality of Life Assessment (WHOQOL)(Baseline and Follow-up (12 weeks))
研究者
Beny Lafer
Principal INvestigator
University of Sao Paulo