Effects of Intradialytic Exercise on Dialytic Parameters, Health-related Quality of Life, and Depression Status in Hemodialysis Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Dialytic parameters: red blood cell [count/ul]
研究概览
简要总结
This study aimed to evaluate the effects of intradialyic exercise on dialytic parameters, HRQL, and depression status in hemodialysis patients. A randomized controlled trial was conducted. Sixty-four participants were recruited using stratified random sampling and allocated with a 1:1 randomization ratio to either experimental group (EG, treated in odd weekdays, n = 32) or comparison group (CG, treated in even weekdays, n = 32). The EG received a 12-week intradialytic exercise, while the CG maintained usual lifestyles. Dialytic parameters, HRQL, and depression status were collected at baseline and at 12 weeks. The results indicated that there were no differences in changes of dialytic parameters from baseline between EG and CG. However, the EG had increased HRQL and reduced depression status at 12 weeks compared with the CG. A 12-week intradialytic exercise is safe, feasible and effective in improved HRQL and reduced depression status for hemodialysis patients.
详细描述
Exercise has been shown to be of fundamental importance in managing chronic diseases and improving health-related quality of life (HRQL) as well as psychological health. However, whether intradialyic exercise is safe and has positive impact on HRQL and depression status in hemodialysis patients requires further researches with diverse racial and cultural groups to clarify. This study aimed to evaluate the effects of intradialyic exercise on dialytic parameters, HRQL, and depression status in hemodialysis patients. A randomized controlled trial was conducted at a medical center in Northern Taiwan. Sixty-four participants from 112 eligible hemodialysis patients were recruited using stratified random sampling and allocated with a 1:1 randomization ratio to either experimental group (EG, treated in odd weekdays, n = 32) or comparison group (CG, treated in even weekdays, n = 32). The EG received a 12-week intradialytic exercise (supine lower-limb ergometer, 30 minutes/session, 3 sessions/week), while the CG maintained usual lifestyles. Dialytic parameters (serum chemistries, serum electrolytes, and estimated glomerular filtration rate), HRQL, and depression status were collected at baseline and at 12 weeks. The results indicated that there were no differences in changes of dialytic parameters from baseline between EG and CG. However, the EG had increased HRQL (ß = 22.6, p<.001) and reduced depression status (ß = -7.5, p = .02) at 12 weeks compared with the CG. A 12-week intradialytic exercise is safe, feasible and effective in improved HRQL and reduced depression status for hemodialysis patients.
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
- Single (Outcomes Assessor)
盲法说明
outcome assessor was blinded to the group assignment
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) ESRD patients on maintenance of hemodialysis; (2) aged 20 to 80 years; (3) able to speak and understand Mandarin; (4) had received regular treatment with hemodialysis (3 times/ week) for at least 6 months; (5) agreed to be randomized to one of the two groups.
排除标准
- •lower limb disabilities, hospitalized patients, treatment with peritoneal dialysis, received hemodialysis less than 3 times/ week, a history of recent acute myocardial infarction, unstable angina, uncontrolled arrhythmia, acute stroke, hospitalization experience within 6 months, cancer, and diagnosed with mental illness, especially depression.
结局指标
主要结局
Dialytic parameters: red blood cell [count/ul]
时间窗: Change from baseline red blood cell [count/ul] assessed by blood analysis at 12 weeks
red blood cell \[count/ul\]
Dialytic parameters: hemoglobin [g/dl]
时间窗: Change from baseline hemoglobin [g/dl] assessed by blood analysis at 12 weeks
hemoglobin \[g/dl\]
Dialytic parameters: GOT [IU/l]
时间窗: Change from baseline GOT [IU/l] assessed by blood analysis at 12 weeks
GOT \[IU/l\]
Dialytic parameters: IPTH [pg/ml]
时间窗: Change from baseline IPTH [pg/ml] assessed by blood analysis at 12 weeks
IPTH \[pg/ml\]
Dialytic parameters: creatinine [Cr, mg/dl])
时间窗: Change from baseline creatinine [Cr, mg/dl]) assessed by blood analysis at 12 weeks
creatinine \[Cr, mg/dl\])
Dialytic parameters: sodium [Na, mEq/l]
时间窗: Change from baseline sodium [Na, mEq/l] assessed by blood analysis at 12 weeks
sodium \[Na, mEq/l\]
Dialytic parameters: mean corpuscular volume [fl]
时间窗: Change from baseline mean corpuscular volume [fl] assessed by blood analysis at 12 weeks
mean corpuscular volume \[fl\]
Dialytic parameters: albumin [g/dl]
时间窗: Change from baseline albumin [g/dl] assessed by blood analysis at 12 weeks
albumin \[g/dl\]
Dialytic parameters: GPT [IU/l]
时间窗: Change from baseline [IU/l] assessed by blood analysis at 12 weeks
GPT \[IU/l\]
Dialytic parameters: hematocrit [%]
时间窗: Change from baseline hematocrit [%] assessed by blood analysis at 12 weeks
hematocrit \[%\]
Dialytic parameters: blood urea nitrogen [BUN, mg/dl]
时间窗: Change from baseline blood urea nitrogen [BUN, mg/dl] assessed by blood analysis at 12 weeks
blood urea nitrogen \[BUN, mg/dl\]
Dialytic parameters: phosphate [P, mg/dl]
时间窗: Change from baseline phosphate [P, mg/dl] assessed by blood analysis at 12 weeks
phosphate \[P, mg/dl\]
Dialytic parameters: potassium [K, mEq/l]
时间窗: Change from baseline potassium [K, mEq/l] assessed by blood analysis at 12 weeks
potassium \[K, mEq/l\]
Dialytic parameters: calcium [Ca, mg/dl]
时间窗: Change from baseline calcium [Ca, mg/dl] assessed by blood analysis at 12 weeks
calcium \[Ca, mg/dl\]
Dialytic parameters: estimated GFR [ml/min1.73m2])
时间窗: Change from baseline estimated GFR [ml/min1.73m2]) assessed by estimation based on serum creatinine at 12 weeks
estimated GFR \[ml/min1.73m2\])
health-related quality of life assessed by the scale of SF-36
时间窗: Change from baseline health-related quality of life at 12 weeks
self-reported health-related quality of life
depression status assessed by the scale of Beck Depression inventory
时间窗: Change from baseline depression status at 12 weeks
self-reported depression status
次要结局
未报告次要终点
研究者
CHIA-HUEI LIN, PhD
Associate professor
Tri-Service General Hospital