The Effect of Exercise on Dialysis Patients' Survival

March 27, 2023 updated by: Pardis Specialized Wellness Institute

The Effect of Intradialytic Exercise on Dialysis Patients' Survival: A Randomized Controlled Trial

The purpose of this study is to check if patients' exercise during their dialysis sessions can prevent their early deaths.

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, 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.

Studies have shown that exercise can produce many different effects in these patients. However, exercise interventions are often short-term, and even in long-term cases, the aim of studies is only to examine a number of hematological factors or factors such as functional capacity in these patients.

A study is currently being designed to directly evaluate the impact of exercise on patients' survival.

To test this hypothesis, patients do exercise for 6 months during dialysis. And then will be monitored for a year to determine patients' survival.

During 6 months of intervention, hematological parameters, nutrition index and functional capacity of patients are evaluated.

In the analyzes, the survival rate of patients in one year follow-up period is compared between patients who took part in intradialytic sessions (intervention group) and patients who did not do any physical activity during dialysis (control group). In addition, by analyzing the variables measured during the 6 months of the intervention, the effect of exercise on parameters relating to survival is evaluated.

Study Type

Interventional

Enrollment (Actual)

74

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

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 1RM 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
Measure Description
Time Frame
1-year Survival of dialysis patients
Time Frame: Follow-up phase (1- year)
Mortality data is gathered using form "CMS-2746" which is specifically for dialysis patients.
Follow-up phase (1- year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of changes of Albumin 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 Hemoglobin 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 Hematocrit 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 Red Blood Cells 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 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 Hormone for 6 months
Time Frame: Pre_test and every 3 months for 6 months
Pre_test and every 3 months for 6 months
Changes of GNRI for 6 months
Time Frame: Pre_test and every 3 months for 6 months
The Geriatric Nutritional Risk Index (GNRI) is a screening method that was primarily developed to identify older patients with malnutrition. It consists of serum albumin levels as well as body weight measurements. GNRI is associated with an increasing risk of long-term all-cause mortality in prevalent hemodialysis patients, even after adjusting for age and comorbidity
Pre_test and every 3 months for 6 months
Changes of the meters walked during the 6MWT for 6 months
Time Frame: Pre_test and every 3 months for 6 months
Six-minute walk test (6MWT) is a walking endurance assessment measured in meters of total distance completed over 6 minutes
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

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)

January 25, 2020

Primary Completion (Actual)

August 9, 2021

Study Completion (Actual)

August 9, 2021

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA20HD-2-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data 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 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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