Effectiveness of a Multicomponent Exercise Program on Health Status and Health-related Quality of Life in Patients With Severe Mental Illness: Study Protocol for a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Prevalence of metabolic syndrome
研究概览
简要总结
People with severe mental disorders have a mortality rate 2 to 3 times higher than that of the general population, largely due to the presence of comorbidities, with a predominance of cardiovascular disease. This population has a higher risk of developing metabolic syndrome compared to the healthy population. Several factors are involved. The usual pharmacological treatment in people with severe mental disorder is a risk factor for the development of metabolic syndrome and deterioration of physical condition. This is generally compounded by poor health care, high-calorie diets, a sedentary lifestyle, difficulties in coping with life situations that generate emotional states (anxiety and/or depression) that result in unhealthy lifestyle habits related to food, activity, interpersonal relationships, sleep, consumption habits (tobacco, alcohol and drugs) and other environmental factors. Physical exercise has been proposed as one of the most effective treatments to reverse the negative consequences of low levels of physical activity in this population. However, the mechanism of action of exercise on health status and the optimal "dose" and intensity of exercise to achieve the greatest number of benefits with respect to cardiometabolic health in patients with severe mental disorder are unknown.The study will be carried out at the Mental Health Rehabilitation Unit of Navarra, a center under the Mental Health Management of Osasunbidea, where people between 18 and 65 years of age with a diagnosis of severe mental illness in a situation of clinical stability receive treatment.The sample will be composed of 100 participants from consecutive admissions to the Rehabilitation Unit. The subjects will be randomized into 2 groups; a control group that will receive the usual specialized care and an intervention group, which in addition to receiving the usual rehabilitation treatment, will undergo a 6-week multicomponent physical exercise program performed 2 days per week. The effects of exercise on the inflammatory profile, metabolic parameters, physical condition, cognitive function, vascular function, muscle strength, health-related quality of life, lifestyle habits (diet, activation, sleep, substance use) and mood will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •resident in Navarra
- •diagnosis of severe mental disorder (DSM 5: Schizophrenia 295.90, Tr. Schizoaffective Disorder 295.70, Schizotypal Personality Disorder 301.22, Schizoid Personality Disorder 301.20, Schizophreniform Personality Disorder 295.40, Psychotic Disorder with Delusional Ideas 295.40, Psychotic Disorder with Delusional Ideas 295.
- •Schizophreniform 295.40, Psychotic disorder with delusions 293.81, Psychotic disorder with hallucinations 293.82, Major depressive disorder 296.33, Bipolar disorder type I 296.44, Bipolar disorder type II 296.89, Obsessive Compulsive Disorder
- •primary nursing diagnosis NANDA and Virginia Henderson NOC 0099 Ineffective Health Maintenance
- •at least one of the secondary nursing diagnoses 001 Nutritional Imbalance due to Excess, 003 Risk of Nutritional Imbalance due to Excess, 00096 Sleep Deprivation, 00146 Anxiety or 00168 Sedentary
- •willing to voluntarily participate in the randomly assigned intervention, after signing the informed consent form.
排除标准
- •acute illness that does not allow physical exercise sessions or assessments during the study
- •medical contraindication that prevents physical exercise
- •treatment with Interleukin-6 receptor antagonists (tocilizumab) during the last month due to drug interference with adaptations to cardiopulmonary exercise
- •refusal to sign the informed consent form by the study subject
- •impossibility of follow-up.
研究组 & 干预措施
Control group
Patients in this group will receive clinical usual care.
Exercise training group
An individualized multicomponent exercise program including resistance, aerobic, balance and flexibility exercises.The duration of the sessions will be 45 minutes, and the duration of the whole program will be 6 weeks, equivalent to 12 sessions.
干预措施: Physical exercise (Other)
结局指标
主要结局
Prevalence of metabolic syndrome
时间窗: 14 weeks
Any 3 of the 5 features: Waist circumference (\> 102 cm men/ \> 88 cm women),Elevated triglycerides (\> 150 mg/dl), reduced HDL cholesterol (\< 40 mg/dl men/ \< 50 mg/dl women), elevated blood pressure(\> 130 mmHg Systolic blood pressure or \> 85 mmHg Diastolic blood pressure), and elevated fasting glucose (\> 100 mg/dl) glucose.
次要结局
- Densitometry(14 weeks)
- Vascular stiffness(14 weeks)
- European Quality of Life-5 Dimensions (EuroQol-5D)(14 weeks)
- Screen for Cognitive Impairment in Psychiatry (SCIP)(14 weeks)
- Adverse events related to medication(14 weeks)
- Beck questionnaire(14 weeks)
- State Strait Anxiety Inventory (STAI)(14 weeks)
- Muscle mass(14 weeks)
- Medication(14 weeks)
- Oviedo questionnaire(14 weeks)
- Muscle strength(14 weeks)
- Positive And Negative Syndrome Scale (PANSS)(14 weeks)
- The Matrics Consensus Cognitive Battery(At baseline)
- Physical condition(14 weeks)
- Blood pressure(14 weeks)
- Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)(14 weeks)
- Medical history of substance abuse(14 weeks)
- International Physical Activity Questionnaire (IPAQ)(14 weeks)