Institutional Review Board of the Cardinal Tien Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 主要终点
- Generalized estimating equation model on the effects of depression, fatigue, and health-related quality of life
研究概览
简要总结
Aim. To investigate the effect of an intradialytic aerobic and resistance cycling exercise program (IARCEP) on depression, fatigue, and quality of life (QOL) in end-stage renal disease (ESRD) patients receiving haemodialysis, and further determine the effect of mediation through self-efficacy and resilience in patients receiving the IARCEP.
Background. Depression and fatigue are common in ESRD patients undergoing haemodialysis, which negatively affects their QOL. Exercise can mitigate this effect. Patient's self-efficacy and resilience may be crucial mediators in exercise.
Design. This study was a randomised controlled trial. Method. Seventy-six participants were randomly assigned to either a control or exercise group. Both groups received routine care; whereas the exercise group participated the 3- months IARCEP. Data were collected at baseline, the first, second, and third months, over a 14 months in 2013-2014.
详细描述
According to the United States Renal Data System (2015), in 2013, 88.2% of all incident cases of ESRD involved renal replacement therapy with haemodialysis, ESRD is highly prevalent in Taiwan, with 2,902 cases per million people; 89.7% of cases in 2012 involved maintenance haemodialysis treatment as the renal replacement therapy. Patients generally receive haemodialysis 3 days per week, and each session generally takes 4 hr. Beginning dialysis induces multiple physical and psychological stressors in patients. In particular, the importance of intervention programs improving psychosocial function should be noted considering disease and its long-term treatment. High depression and fatigue are crucial for consideration in the global care of dialysis patients because these factors are associated with mortality. A significant correlation exists between reduced physical activity and increased depression or fatigue; with decreased activity, muscle strength decreases, which exacerbates depression and fatigue.
Depression is the most common psychosocial problem observed in ESRD patients undergoing haemodialysis, with a prevalence between 27.9% and 40.2% associated with a high risk of hospitalisation and prolonged hospital stay, reduced quality of life (QOL), decreased adherence to dialysis prescriptions, and increased medical comorbidity.
Fatigue is another critical concern caused by haemodialysis; ESRD patients receiving haemodialysis have reduced red blood cell production, thus causing fatigue, the prevalence of which ranges between 53% and 97%. Fatigue has a negative effect on the physical function, ability to perform daily activities, QOL, and even survival of patients. QOL is the subjective perception of an illness and corresponding treatment regarding physical, psychological, and social well-being; however, QOL serves as a prognostic measure and predictor of survival. ESRD patients receiving haemodialysis have a lower QOL than do other patients with other chronic illnesses and general population. Lower health-related QOL is associated with higher rates of hospitalisation and lower rates of survival among patients undergoing haemodialysis. Therefore, identifying effective interventions to assist ESRD patients receiving haemodialysis in managing their physical, psychological, and social problems is critical.
Regular exercise could improve general health in many chronically ill patients. Planned exercise programs are nonpharmacological interventions that can safely and effectively improve depression, fatigue, and QOL. For ESRD patients undergoing haemodialysis, many previous studies have shown that exercise decreases fatigue and depression, and improves QOL. Accordingly, an intradialytic exercise program should be considered as a possible therapeutic approach for improving fatigue, depression, and QOL in ESRD populations and should be encouraged by and performed in haemodialysis centres. Although the benefits of related exercise programs are known, an effective intradialytic exercise program for routine therapy has not yet been developed. Few previous studies have implemented exercise programs to examine the effects of psychological factors and QOL on patients receiving haemodialysis in Taiwan.
Exercise self-efficacy is a crucial mediator of health behaviour. Self-efficacy is a key construct in social-cognitive theory, in which personal beliefs correspond to an individual's perceived ability to successfully perform specific tasks and activities. Pertaining to beliefs in a person's ability to manage prospective situations, self-efficacy beliefs focus on mediating change in individual behaviours. Thus, self-efficacy has a mediating effect on depression resulting from stressful events. Self-efficacy as a mediator complements family and healthcare provider support in diminishing the negative impact of depression in haemodialysis patients. Relevantly, resilient people tend to have apparent adaptive behaviours, particularly those related to somatic health. Resilience specifically refers to smooth and rapid recovery from setbacks that may occur in a person's life. As such, psychological resilience is considered a protective mechanism that operates in the presence of negative stressors. People who are maladaptive with low competence and low adversity score lower on these measures than resilient and competent groups do. Exercise self-efficacy, resilience, and exercise behaviour are interrelated. Self-efficacy may motivate people to perform their physical activity. However, the true effect of exercise programs fails to account for the mediating effects of exercise self-efficacy and resilience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 24 Years 至 79 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 20 years
- •provided consent to participate in this study
- •received haemodialysis 3 times per week for least 3 months
- •missed no more than two dialysis sessions in the previous month
- •had an adequate dialysis, counted by Kt / V over 1.2
- •no lower dialysis graft, basic comprehension and communication in Mandarin or Taiwanese
- •on positive response to any of the supplementary questions in the Physical Activity Readiness Questionnaire (PAR-Q).
排除标准
- •is currently infection or inflammation, autoimmunity disorders, cerebrovascular accidents in the previous 6 months
- •severe muscle weakness or interfering skeletal deformities on lower limbs
- •history of repeated episodes of hypoglycaemia, cardiopulmonary contraindications to resistance exercise (e.g., myocardial infarction, active angina, and uncompensated congestive heart failure in the previous 6 months)
- •lower limb amputation
- •history of participating regularly in exercise programs over 3 months.
结局指标
主要结局
Generalized estimating equation model on the effects of depression, fatigue, and health-related quality of life
时间窗: Data were collected over a 14 months in 2013-2014.
次要结局
- Differences-in-differences on the effects of the depression, fatigue, quality of life in exercise group(Data were collected over a 14 months in 2013-2014.)
- Generalized estimating equation on the mediated effects of self-efficacy and resilience with exercise on outcomes(Data were collected over a 14 months in 2013-2014.)
- The mediated effects on relationships between exercise and outcomes(Data were collected over a 14 months in 2013-2014.)
研究者
Yueh-Min LIU
Institutional Review Board
Cardinal Tien Hospital
