The Effect of Exercise on Blood Parameters Related to Dialysis Patients' Survival

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Kidney Diseases, End Stage Renal Disease, Hemodialysis

Intervention / Treatment
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* Other: Intradialytic exercise group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dialysis history ≥ 1 year Without myocardial infarction within past 3 months Regular dialysis 3 times a week Ability to consent Doctor's consent Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly allocate to intervention group or control group and will be examined in the same way.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>The patients will participate in intradialytic exercise 3 times a week for 24 weeks. | Other: Intradialytic exercise group<br>* Participants will do concurrent exercise (a combination of aerobic exercise and resistance training) for 30-60 minutes during the second hour of their routine hemodialysis sessions. To determine the intensity of the prescribed exercise, maximum heart rate is used for aerobic workout and 5 Repetitions Maximum (5RM) for resistance protocols. Exercises will be performed at a moderate exercise intensity (12-14 on the Borg RPE Scale). All protocols are tailor-made based on each individual's needs and physical abilities.<br>|
| No Intervention: Control group<br>The patients will receive regular care and treatment in every dialysis sessions without any intradialytic exercise. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of changes of Calcium 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 | 
| Rate of changes of Parathyroid Hormones for 6 months |  | Pre_test and every 3 months for 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mortality, Mortality Rate, Survival, Cardiovascular Disease, Osteoporosis, Bone Mineral Disorders, Exercise during dialysis