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Completed

NCT Number: NCT04898608

The Effect of Exercise on Dialysis Patients' Survival

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

intradialytic exercise

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rate of changes of Albumin for 6 months

    Time frame: Pre_test and every 3 months for 6 months

  2. Rate of changes of Hemoglobin for 6 months

    Time frame: Pre_test and every 3 months for 6 months

  3. Rate of changes of Hematocrit for 6 months

    Time frame: Pre_test and every 3 months for 6 months

  4. Rate of changes of Red Blood Cells for 6 months

    Time frame: Pre_test and every 3 months for 6 months

  5. Rate of changes of Calcium for 6 months

    Time frame: Pre_test and every 3 months for 6 months

  6. Rate of changes of Phosphorus for 6 months

    Time frame: Pre_test and every 3 months for 6 months

  7. Rate of changes of Parathyroid Hormone for 6 months

    Time frame: Pre_test and every 3 months for 6 months

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Pardis Specialized Wellness Institute

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 24, 2021
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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