Intradialytic High-Intensity Interval Training in Hemodialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05257668
• Other study ID #: Intradialytic HIIT
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: June 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• High Intensity Interval Exercise Training
High Intensity Interval Training Group
• Moderate Intensity Exercise Training
Moderate Intensity Training Group

Locations

Country	Name	City	State
Turkey	Istanbul University- Cerrahpasa	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Yasemin ASLAN KELES	Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dialysis Adequacy	Kt/V	8 weeks
Primary	6 Minute Walking Test	Functional Capacity	8 weeks
Primary	5X Sit-to-Stand Test	Functional Capacity	8 weeks
Primary	Kidney Disease Quality of Life-36	Life Quality	8 weeks
Secondary	Beck Depression Scale	Mild depression (11-17 points) Moderate depression (18-29 points) Severe depression (30-63 points)	8 weeks
Secondary	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
Secondary	Quadriceps muscle strength	Muscle testing with dynamometer	8 weeks