The Effect of Intradialytic Exercise on Dialysis Patients' Survival: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- 1-year Survival of dialysis patients
研究概览
简要总结
The purpose of this study is to check if patients' exercise during their dialysis sessions can prevent their early deaths.
详细描述
Dialysis patients suffer from a number of problems, one of which is reduced ability, decreased functional capacity, and consequently reduced physical capability. Forced inactivity due to immobility in dialysis sessions and the need to rest and relieve fatigue for a few hours after each session cause patients to become more inactive day by day, and according to various studies, inactivity in these patients along with reduced physical capabilities increase the risk of cardiovascular disease, which is a risk factor for mortality in these patients.
On the other hand, inactivity is an independent predictor of hospitalization and mortality in these patients.
Studies have shown that exercise can produce many different effects in these patients. However, exercise interventions are often short-term, and even in long-term cases, the aim of studies is only to examine a number of hematological factors or factors such as functional capacity in these patients.
A study is currently being designed to directly evaluate the impact of exercise on patients' survival.
To test this hypothesis, patients do exercise for 6 months during dialysis. And then will be monitored for a year to determine patients' survival.
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 (Outcomes Assessor)
盲法说明
The lab tech will be blind to whether the sample under evaluation belongs to the intervention group or the control group. A research project collaborator who is not informed about grouping of participants will obtain outcome measurements of the functional test. Outcome adjudicators, and data analysts will be kept blinded to the allocation. Moreover, all investigators, staff, and participants will be kept masked to outcome measurements and trial results.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dialysis history ≥ 1 year
- •Without myocardial infarction within past 3 months
- •Regular dialysis 3 times a week
- •Ability to consent
- •Doctor's consent
排除标准
- •Unstable cardiac status (angina, decompensated congestive heart failure, severe arteriovenous stenosis, uncontrolled arrhythmias, etc.)
- •Active infection or acute medical illness
- •Hemodynamic instability
- •Labile glycemic control
- •Unable to exercise (lower extremity amputation with no prosthesis)
- •having severe musculoskeletal pain at rest or with minimal activity
- •Unable to sit, stand or walk unassisted (walking device such as cane or walker allowed)
- •Having shortness of breath at rest or with activities of daily living (NYHA Class IV)
结局指标
主要结局
1-year Survival of dialysis patients
时间窗: Follow-up phase (1- year)
Mortality data is gathered using form "CMS-2746" which is specifically for dialysis patients.
次要结局
- Rate of changes of Calcium for 6 months(Pre_test and every 3 months for 6 months)
- Changes of GNRI for 6 months(Pre_test and every 3 months for 6 months)
- Rate of changes of Albumin for 6 months(Pre_test and every 3 months for 6 months)
- Rate of changes of Parathyroid Hormone for 6 months(Pre_test and every 3 months for 6 months)
- Rate of changes of Hemoglobin for 6 months(Pre_test and every 3 months for 6 months)
- Rate of changes of Hematocrit for 6 months(Pre_test and every 3 months for 6 months)
- Rate of changes of Phosphorus for 6 months(Pre_test and every 3 months for 6 months)
- Changes of the meters walked during the 6MWT for 6 months(Pre_test and every 3 months for 6 months)
- Rate of changes of Red Blood Cells for 6 months(Pre_test and every 3 months for 6 months)