The Effect of Physical Exercises Program on Social Functioning, Alexithymia and Sense of Coherence Among Patients With Bipolar Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The Social Functioning Scale (SFS)
研究概览
简要总结
The aim of this study is to:
Investigate the effect of applying physical exercises program on social functioning, alexithymia and sense of coherence among patients with bipolar disorders Research Hypotheses
- Clients who participated in physical exercises program will exhibit better social functioning and sense of coherence than the control group.
- Clients who participated in physical exercises program will exhibit less alexithymia than the control group.
详细描述
- Psychotic male patients' wards will be randomly selected using simple random sampling technique. The first selected ward will be assigned for the first small study group and its control group. The second selected ward will be assigned for the second study and control group and so on. Then the wards will be revisited again in the same order to achieve the required number of subjects.
- Patients' medical charts in the selected wards will be reviewed to identify those who meet the inclusion criteria. From all patients who meet the predetermined inclusion criteria in the selected ward, the patients will be recruited using simple randomization technique.
- A medical checkup will be performed for patients in the study group to exclude any contraindications for carrying out physical exercise.
- The study group (20 patients) will be divided into 4 small groups of 5 patients. Every patient will be interviewed individually to establish rapport and build trustful relationship. Time of each interview will take from 15 to 30 minutes according to patient's familiarity with the researcher, willingness to talk or cooperate and cognitive abilities. By the end of these interviews, the researcher will explain the purpose of the study, and an informed written consent will be obtained from each patient.
- Patients from the study and control groups will be interviewed and observed individually by the researcher to apply the study tools.
- Physical exercises will be carried out for patients in the study group while those in the control group will be left to undergo the usual hospital routine. The physical exercise intervention phase will take three weeks for each patient (three sessions per week for three weeks - Nine sessions for each group). It will be applied for two groups each week for three weeks (one group / day - 3 sessions /week for each group - six days/ week for the two groups).
- Patients' addresses and telephone numbers will be kept in confidential notebook by the researcher after taking their permission to facilitate follow up of patients at the outpatient level to collect data after intervention.
- After termination of the physical exercise program, every patient recruited in both groups will be interviewed immediately using the study tools. In addition, after three months of discharge, patients in both groups will be interviewed and observed at the outpatient level.
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male patients with no co-morbidity, with duration of illness not exceeding 10 years, physically fit to be able to participate in physical exercise (based on physician recommendations), recently admitted (2 - 3 weeks)
排除标准
- 未提供
研究组 & 干预措施
STUDY GROUP
Physical exercises will be carried out for patients in the study group . The physical exercise intervention phase will take three weeks for each patient (three sessions per week for three weeks - Nine sessions for each group). It will be applied for two groups each week for three weeks (one group / day - 3 sessions /week for each group - six days/ week for the two groups).
干预措施: Physical exercises program (Behavioral)
Control group
Those in the control group will be left to undergo the usual hospital routine
干预措施: Physical exercises program (Behavioral)
结局指标
主要结局
The Social Functioning Scale (SFS)
时间窗: 2 weeks
The SFS is a self-administered questionnaire and consists of 79 items with varying response format (dichotomous questions, three point likert scale, four point likert scale and five point likert scale). These items are classified into seven subscales; withdrawal/social engagement )5 items), interpersonal communication (4 items), independence-performance(13 items), independence-competence (13 items), recreation (15 items), prosocial activities (22 items), and employment/occupation(5 items), in addition to two unscored preliminary questions.
Toronto Alexithymia Scale
时间窗: 2 weeks
The Toronto Alexithymia Scale (TAS-20) was developed by (Bagby, Taylor, \& Parker, 1994) and it is a 20-items, self-administered questionnaire that measures difficulty in identifying and describing emotions, which is a big part of alexithymia. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. There are 5 items that are negatively keyed (items 4, 5, 10, 18 and 19). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
The Sense of Coherence
时间窗: 2 weeks
The SOC scale was developed by Antonovsky to measure the concept of sense of coherence. The short form of the SOC scale consists of 13 items that comprise three components: comprehensibility (to which 5 items contribute), manageability (4 items), and meaningfulness (4 items). The respondents indicate agreement or disagreement on a 7-category semantic differential scale with two anchoring responses tailored to the content of each item. Five items (1, 2, 3, 5, and 7) are reversed before summing the total score. The total score can range from 13 to 91, and a higher score indicates higher SOC
次要结局
未报告次要终点
研究者
Mahmoud Khedr
Lecturer
Alexandria University