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

P

Pardis Specialized Wellness Institute

Status

Completed

Conditions

Chronic Kidney Diseases
Hemodialysis
End Stage Renal Disease

Treatments

Other: Intradialytic exercise group

Study type

Interventional

Funder types

Other

Identifiers

NCT04916743
PA21HD-2-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

Exercise group
Experimental group
Description:
The patients will participate in intradialytic exercise 3 times a week for 24 weeks.
Treatment:
Other: Intradialytic exercise group
Control group
No Intervention group
Description:
The patients will receive regular care and treatment in every dialysis sessions without any intradialytic exercise.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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