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NCT Number: NCT05257668

Intradialytic High-Intensity Interval Training in Hemodialysis Patients

Chronic Kidney Disease (CKD) is defined as a chronic, progressive degeneration state in the regulation of the fluid-electrolyte balance of the kidney and metabolic-endocrine functions as a result of the glomerular filtration rate (GFR) falling below 60 ml/min/1.73 m², regardless of the etiology of the kidney disease. End Stage Renal Failure (ESRD) is the last stage of CRF and is a life-threatening condition. Although the majority of ESRD patients survive on dialysis, their quality of life and functional capacity decrease due to uremic cardiomyopathy, cardiovascular diseases, anemia, diabetes mellitus, bone diseases, deconditioning, fatigue, weakness, inactivity and accompanying psychological problems.

Rehabilitation program including exercise in CKD patients; The program, which is performed under observation on non-dialysis days, can be applied in three ways: the (intradialytic) rehabilitation program performed during hemodialysis in the dialysis unit, and the home exercise program. Intradialytic exercise (IDE) is defined as exercise training performed during the hemodialysis session to increase the patient's strength and endurance and thus target various physiological and psychosocial parameters. Three types of exercises are generally recommended in the exercise program for dialysis patients. These are aerobic exercise, strengthening exercise, and combined aerobic and resistance exercise program. Aerobic exercise (both on dialysis and on non-dialysis days) is the most common type of exercise used in hemodialysis patients. It is stated that physical exercise improves the exercise capacity, muscle strength, functional capacity and quality of life of patients receiving dialysis treatment, provides blood pressure control, reduces the risk of diabetes development and cardiovascular disease, alleviates depression and anxiety symptoms, increases survival and dialysis efficiency.

When the literature is examined, no study has been found that examines how the application of high-intensity intermittent exercise training, which has very important advantages, in the intradialytic process has an effect. Therefore, the aim of our study is to compare the effects of intradialytic high-intensity intermittent exercise training and moderate-intensity exercise training on dialysis effectiveness, functional capacity and quality of life in hemodialysis patients.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between the ages of 20-65
  • Having Stage 5 (ESRD) CRF according to GFR
  • Literate
  • Cooperative
  • Dialysis treatment for at least three months

Exclusion criteria

  • History of myocardial ischemia in the last 6 months
  • Uncontrollable diabetes mellitus,
  • Uncontrollable hypertension
  • Heart failure
  • Malignant disease
  • Mental retardation
  • Illiteracy
  • Uncooperative
  • Neurological or orthopedic disability

Treatment and study plan

High Intensity Interval Exercise Training

Other

High Intensity Interval Training Group

Moderate intensity exercise training

Other

Moderate Intensity Training Group

Primary outcomes

  1. Dialysis Adequacy

    Time frame: 8 weeks

    Kt/V

  2. 6 Minute Walking Test

    Time frame: 8 weeks

    Functional Capacity

  3. 5X Sit-to-Stand Test

    Time frame: 8 weeks

    Functional Capacity

  4. Kidney Disease Quality of Life-36

    Time frame: 8 weeks

    Life Quality

Secondary outcomes

  1. Beck Depression Scale

    Time frame: 8 weeks

    Mild depression (11-17 points) Moderate depression (18-29 points) Severe depression (30-63 points)

  2. Visual Analogue Scale

    Time frame: 8 weeks

    To evaluate Fatigue. Each line is 100 mm in length - thus, scores fall between 0 and 100.Scoring : 0 : not all tired 100: extremely tired (left end of scale=not tired at all, right end of scale=extremely tired)

  3. Quadriceps muscle strength

    Time frame: 8 weeks

    Muscle testing with dynamometer

Sponsors and collaborators

Lead sponsor

Yasemin ASLAN KELEŞ

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Official study title

The Effect of Intradialytic High-Intensity Interval Training and Moderate Intensity Training on Dialysis Adequacy and Functional Capacity in Hemodialysis Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2022
Registry last updated
Jun 22, 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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