Intradialytic High-Intensity Interval Training in Hemodialysis Patients

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

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Exercise, Compulsive
• Intervention / Treatment: Other: High Intensity Interval Exercise Training; Other: Moderate Intensity Exercise Training

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34500
    • Istanbul University- Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; High intensity interval training	Other: High Intensity Interval Exercise Training; High Intensity Interval Training Group
Active Comparator: Group 2; Moderate intensity training	Other: Moderate Intensity Exercise Training; Moderate Intensity Training Group
No Intervention: Group 3; Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dialysis Adequacy	Kt/V	8 weeks
6 Minute Walking Test	Functional Capacity	8 weeks
5X Sit-to-Stand Test	Functional Capacity	8 weeks
Kidney Disease Quality of Life-36	Life Quality	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Scale	Mild depression (11-17 points) Moderate depression (18-29 points) Severe depression (30-63 points)	8 weeks
Visual Analogue Scale	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)	8 weeks
Quadriceps muscle strength	Muscle testing with dynamometer	8 weeks

Collaborators and Investigators

• Sponsor: Yasemin ASLAN KELEŞ
• Collaborators: Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 17, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: chronic kidney disease; functional capacity; dialysis adequacy; high-intensity interval training; intradialytic exercise
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Compulsive Behavior; Impulsive Behavior; Behavior, Addictive; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic; Compulsive Exercise
• Other Study ID Numbers: Intradialytic HIIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No