Clinical Trials Directory

Trials / Completed

CompletedNCT04916743

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
44 (actual)
Sponsor
Pardis Specialized Wellness Institute · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
OTHERIntradialytic exercise groupParticipants 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.

Timeline

Start date
2021-07-30
Primary completion
2022-01-29
Completion
2022-01-29
First posted
2021-06-08
Last updated
2022-03-21

Locations

2 sites across 1 country: Iran

Source: ClinicalTrials.gov record NCT04916743. Inclusion in this directory is not an endorsement.

The Effect of Exercise on Blood Parameters Related to Dialysis Patients' Survival (NCT04916743) · Clinical Trials Directory