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临床试验/NCT04916743
NCT04916743已完成不适用

The Effect of Intradialytic Exercise on Calcium, Phosphorus and Parathyroid Hormone: A Randomized Controlled Trial

Pardis Specialized Wellness Institute3 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
3
主要终点
Rate of changes of Calcium for 6 months

研究概览

简要总结

The purpose of this study is to check if patients' exercise during their dialysis sessions can improve the blood parameters which affect the heart disease and osteoporosis, so that we can help patients live longer.

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 (CVD), 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.

The mortality rate of dialysis patients is much higher than that of healthy people, to the extent that it is reported to be about 10 to 30 times higher. The life expectancy of these patients is between 30 and 50 percent lower than that of people without the same age and sex. Dialysis patients suffer from many CVDs such as high blood pressure, vascular disease, congestive heart failure and arrhythmias. CVDs in patients are related to traditional risk factors such as diabetes, hypertension, sedentary lifestyle and non-traditional risk factors such as anemia, inflammation, abnormal calcium metabolism and phosphorus and oxidative stress. Studies have shown that high levels of calcium, phosphorus , calcium- phosphorus product and parathyroid hormone are associated with fatal and non-fatal cardiovascular events and all-cause mortality in dialysis patients.

One of the most common complications of chronic kidney disease is hypophosphatemia. Phosphate metabolism is regulated by the interaction of the kidneys, bones and intestines. This balance is impaired in kidney patients and the calcification process occurs through disturbances in the regulation of calcium, phosphate, and hyperparathyroidism. Hyperparathyroidism is considered as one of the aggravating causes of anemia as well as resistance to erythropoietin treatment in hemodialysis patients. Due to the effect of parathyroid hormone in the regulation of calcium and the anabolic and catabolic role of the bones, the regulation of this hormone is essential for all people, especially dialysis patients.

Human studies have shown that the regulation of parathyroid hormone and calcium and phosphorus metabolism are dependent on physical activity, and they have introduced exercise as an effective way to regulate this hormone. Considering the various effects of exercise on dialysis patients, a study has been designed to investigate the effect of concurrent exercise during dialysis on changes in calcium levels, phosphorus, calcium-phosphorus product, and parathyroid hormone.

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. 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

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

Rate of changes of Calcium for 6 months

时间窗: Pre_test and every 3 months for 6 months

Rate of changes of Parathyroid Hormones for 6 months

时间窗: Pre_test and every 3 months for 6 months

Rate of changes of Phosphorus for 6 months

时间窗: Pre_test and every 3 months for 6 months

次要结局

  • Rate of changes of Calcium-Phosphorous product for 6 months(Pre_test and every 3 months for 6 months)
  • Rate of changes of Alkaline Phosphatase for 6 months(Pre_test and every 3 months for 6 months)

研究者

发起方
Pardis Specialized Wellness Institute
申办方类型
Other
责任方
Sponsor

研究点 (3)

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