The Effectiveness of Lower Extremity Strength Training on the Physical Performance of Patients With Chronic Schizophrenia With Sarcopenia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Short Physical Performance Battery (SPPB)
研究概览
简要总结
The increase in chronic schizophrenia patients with sarcopenia is currently an important healthcare issue in Taiwan and requires enhanced prevention and progress. Therefore, the purpose of this study was to understand the prevalence of sarcopenia in patients with chronic schizophrenia and to explore the effect of lower limb strength training on the physical functional performance of patients with chronic schizophrenia and sarcopenia. This study adopted a quasi-experimental design method, and the research process was divided into two stages. In the first stage, the SARC-CalF questionnaire was used to initially screen suspected chronic schizophrenia patients in a psychiatric hospital in central Taiwan. For sarcopenia cases, the skeletal muscle mass index (Skeletal Muscle Mass index) of suspected sarcopenia cases is further compared with the body composition analyzer (Inboby) to confirm the diagnosis of sarcopenia. Statistical analysis of the prevalence of sarcopenia in patients with chronic schizophrenia. In the second phase of the study, 4 chronic disease areas (two chronic disease areas for men and women) were randomly divided into experimental groups and control groups. The experimental group received a 16-week lower limb muscle strength training program, while the control group received routine care. The two groups conducted one pre-test and two post-tests, and the measurement content included physical function performance (Short Physical Performance Battery (SPPB), sarcopenia quality of life (SarQoL), and fall incidence). It is expected that the development of a set of non-pharmacological care measures will help patients in chronic psychiatric wards to become independent and slow down the progression of sarcopenia.
详细描述
Methods:
The purpose of this study was to investigate the effects of lower extremity muscle training on the functional performance of sarcopenia in patients with chronic schizophrenia . The study will to examine the effectiveness of a 16-week lower extremity muscle training program on the functional performance of of sarcopenia in patients with chronic schizophrenia Sample size calculation. Sample size was calculated using G*Power 3.1.9.2 software, with reference to a randomized controlled study (Nygård et al., 2023) on the integration of plyometric training into the long-term collaborative care of people with psychosis. ANOVA: Repeated measures, between factors, Effect size: 0.5, α = 0.05, Power = 0.8, 2 groups, 3 measurements per group, results showed that at least 24 cases were enrolled in each group. However, in order to increase the statistical validity and to take into account the possibility of dropout or low attendance, the default attrition rate was 25%, with 30 cases in each group. Considering that the ratio of males to females with psychosis is 1.4:1, the sample size of this study is estimated to be 40 cases in each of the experimental and control groups (24 males and 16 females in each group), making a total of 80 subjects.
Data analysis:
In this study, the data were collected and compiled, coded and entered into a computer file, and processed using the SPSS for windows version 22.0 statistical package for statistical analysis, with the significant level set at α=0.05. The data were analyzed and analyzed using the SPSS for windows version 22.0 statistical software.
Steps Based on the screening results, eight chronic wards with a high number of myasthenia gravis chronic psychosis cases were selected and divided into two groups according to gender (24 males and 16 females in each group), which were randomly assigned to the experimental and control groups by drawing lots with an opaque envelope by a non-study project staff member (a nurse practitioner supervisor). After explaining the purpose of the study and the study process to the subjects, and after the subjects had agreed to participate in the study, they were asked to sign the consent form by telephone with their family members (note the date and time of the telephone call for family members' consent). After explaining the purpose of the study and the study process to the subjects, and after the subjects had agreed to participate in the study, they were asked to sign the consent form by telephone with their family members (note the date and time of the telephone call for family members' consent).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Suitable for participation in this study as assessed by the attending physician.
- •(2) After explaining the purpose of the study and the study process, family members and study subjects were asked to agree to participate in the study and to complete the consent form for signature.
排除标准
- •(1) Those who are unable to walk unaided.
- •(2) Severe structural disability that prevents the performance of lower extremity training.
- •(3) Those with severe psychiatric symptoms that prevent them from concentrating and following instructions.
- •(4)Participation in a lower extremity muscle training program or intervention within one year.
结局指标
主要结局
Short Physical Performance Battery (SPPB)
时间窗: baseline、8weeks、16weeks
Chair Stand Test' Chair Stand Test、Balance tests、 Gait speed test
The Sarcopenia Quality of Life Questionnaire (SarQoL-TW)
时间窗: baseline、8weeks、16weeks
Chinese version of the Taiwan version
fall incidence
时间窗: baseline、8weeks、16weeks
medical records
次要结局
未报告次要终点
研究者
Chi-Tzu Shih
Ph.D. candidate
National Taipei University of Nursing and Health Sciences
