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

March 18, 2022 updated by: Pardis Specialized Wellness Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Isfahan, Iran, Islamic Republic of, 813991447
        • Abolfazl medical center
      • Isfahan, Iran, Islamic Republic of
        • Pardis Specialized Wellness Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of changes of Calcium for 6 months
Time Frame: Pre_test and every 3 months for 6 months
Pre_test and every 3 months for 6 months
Rate of changes of Phosphorus for 6 months
Time Frame: Pre_test and every 3 months for 6 months
Pre_test and every 3 months for 6 months
Rate of changes of Parathyroid Hormones for 6 months
Time Frame: Pre_test and every 3 months for 6 months
Pre_test and every 3 months for 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of changes of Calcium-Phosphorous product for 6 months
Time Frame: Pre_test and every 3 months for 6 months
Pre_test and every 3 months for 6 months
Rate of changes of Alkaline Phosphatase for 6 months
Time Frame: Pre_test and every 3 months for 6 months
Pre_test and every 3 months for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pardis Specialized Wellness Institute

Investigators

  • Principal Investigator: Mohammad Ali Tabibi, Dr, Pardis Specialized Wellness Institute
  • Study Director: Mohammad Ali Tabibi, Dr, Pardis Specialized Wellness Institute
  • Principal Investigator: Shahrzad Amirian Farsani, Pardis Specialized Wellness Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2021

Primary Completion (Actual)

January 29, 2022

Study Completion (Actual)

January 29, 2022

Study Registration Dates

First Submitted

June 1, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA21HD-2-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared.

IPD Sharing Time Frame

The data will be available after the paper is published. No end date.

IPD Sharing Access Criteria

The IPD will be available only for our colleagues in Global Renal Exercise (GREX) as long as they have acceptable reasons for requiring the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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