Intradialytic High-Intensity Interval Training in Hemodialysis Patients

NCT05257668 | Completed

• 1 other identifier: Intradialytic HIIT
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease; Exercise, Compulsive

Keywords

intradialytic exercise; high-intensity interval training; chronic kidney disease; dialysis adequacy; functional capacity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Beck Depression Scale

  8 weeks

• Visual Analogue Scale

  8 weeks

• Quadriceps muscle strength

  8 weeks

Study Arms (3)

Group 1

ACTIVE COMPARATOR

High intensity interval training

Other: High Intensity Interval Exercise Training

Group 2

ACTIVE COMPARATOR

Moderate intensity training

Other: Moderate Intensity Exercise Training

Group 3

NO INTERVENTION

Control

Interventions

High Intensity Interval Exercise Training OTHER

High Intensity Interval Training Group

Group 1

Moderate Intensity Exercise Training OTHER

Moderate Intensity Training Group

Group 2

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yasemin ASLAN KELEŞ: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Compulsive Exercise; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: February 25, 2022
• Study Start: October 18, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

TU (1)