Effectiveness of a Multimodal Physical Therapy Program on Clinical Symptomatology and Physical Fitness in Persons With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
The aim of the investigators' study would evaluate the effectiveness of a multimodal exercise program on physical fitness, physical activity level and clinical symptomatology in patients with schizophrenia.
DESIGN: Randomized controlled trial. SUBJECTS OF THE STUDY: People with schizophrenia who receiving treatment in Regional Hospital of Malaga. INTERVENTION: DATA ANALYSIS: descriptive statistics, measuring central tendency and dispersion of the variables study. Inferential statistics will be made between intervention of key variables and outcome.
详细描述
It´s well known that life expectancy of people with severe mental disorders is approximately from 15 to 20 years less compared with general population. The higher mortality risk in this population group reflects a combination of factors: a) increased prevalence of comorbid medical conditions; b) adverse effects of pharmacological treatment; c) higher rates of suicide, accidental and other violent death; d) poorer access to physical healthcare than for the general population. In addition, this vulnerable population has an extremely high prevalence of obesity, nearly twice that of the overall population. Therefore, it is not surprising that persons with serious mental illness have an increased occurrence of weight-related conditions, including heightened risk of diabetes mellitus, hypertension, and dyslipidaemia; in addiction to this, these pathologies are under-diagnosed and under-treated. Environmental issues and unhealthy lifestyle can account for all these conditions, particularly in people with SMI, such as high levels of cigarette smoking, unhealthy diet or sedentary life style. Tendency to isolation and a reduced social network are often obstacles to the practice of physical exercise.
In addition, antipsychotics, in particular atypical antipsychotics, have been associated with weight gain, dyslipidaemia, diabetes, and other cardiac risk factors. Furthermore, the side effects of these medications are one of the most significant barriers to changing their lifestyle.
Finally, the stigma associated with mental illness may also contribute to low levels of participation in mainstream leisure-time physical activities.
Regular practise of physical exercise improves physical and mental health in the general population. A recent systematic review of physical activity and schizophrenia has shown improvement in both positive and negative symptoms, and a general increase in wellbeing of people with schizophrenia. In addition to cardiac and metabolic effects, physical exercise has demonstrated an improvement in both depression and anxiety.
The main objective of this study is to evaluate the effectiveness of a multimodal physical activity programme in physical fitness and physical activity level in persons with a diagnosis of schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Persons with diagnosis of schizophrenia
- •Have agreed to agreeing to participate in the study
- •Have signed the informed consent
- •Be able to complete scales and perform physical tests
排除标准
- •Have a contraindication for performing physical intervention.
- •Destabilization of the symptoms
- •Be participating in a program of structured physical activity
研究组 & 干预措施
Physical intervention group
12 weeks of groupal sessions of individualised multimodal physiotherapy programme of therapeutic exercises with education healthy-style-of-life based, 2 times for week.
干预措施: A multimodal physiotherapy programme (Other)
Control group
This group will receive usual care and will be in wait list status for the duration of study, later the intervention will be offered to this group.
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)
时间窗: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
The Positive and Negative Syndrome Scale--Spanish adaptation. Peralta V. Psychometric properties of the positive and negative syndrome scale (PANSS) in schizophrenia. The spanish version of this scale has a (CCI=0.71 for possitive symptoms; CCI=0.80 for negative symptoms; CCI=0.56 In General psycopatology).
次要结局
- Internalized Stigma of Mental Health questionnaire(Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention))
- Client Service Receipt Inventory (CSRI).(Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention))
- International Physical activity Questionnaire. Short form (IPAQ-7)(Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention))
- 12-Item Short-Form Health Survey(Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention))
- Physical activity (accelerometry)(Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention))
- Self-efficacy and social support for physical activity (SS/SE)(Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention))
- Self-determination motivation in physical fitness(Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention))
- Physical fitness (6-min walk test, Timed up and go test, 30 seconds sit to stand test, handgrip test)(Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention))
研究者
Dr. Antonio I Cuesta-Vargas
PhD
University of Malaga