Intradialytic High-Intensity Interval Training in Hemodialysis Patients
Primary Purpose
End Stage Renal Disease, Exercise, Compulsive
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
High Intensity Interval Exercise Training
Moderate Intensity Exercise Training
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring intradialytic exercise, high-intensity interval training, chronic kidney disease, dialysis adequacy, functional capacity
Eligibility Criteria
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
Sites / Locations
- Istanbul University- Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Group 1
Group 2
Group 3
Arm Description
High intensity interval training
Moderate intensity training
Control
Outcomes
Primary Outcome Measures
Dialysis Adequacy
Kt/V
6 Minute Walking Test
Functional Capacity
5X Sit-to-Stand Test
Functional Capacity
Kidney Disease Quality of Life-36
Life Quality
Secondary Outcome Measures
Beck Depression Scale
Mild depression (11-17 points) Moderate depression (18-29 points) Severe depression (30-63 points)
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)
Quadriceps muscle strength
Muscle testing with dynamometer
Full Information
NCT ID
NCT05257668
First Posted
November 30, 2021
Last Updated
June 17, 2023
Sponsor
Yasemin ASLAN KELEŞ
Collaborators
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT05257668
Brief Title
Intradialytic High-Intensity Interval Training in Hemodialysis Patients
Official Title
The Effect of Intradialytic High-Intensity Interval Training and Moderate Intensity Training on Dialysis Adequacy and Functional Capacity in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yasemin ASLAN KELEŞ
Collaborators
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Exercise, Compulsive
Keywords
intradialytic exercise, high-intensity interval training, chronic kidney disease, dialysis adequacy, functional capacity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
High intensity interval training
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Moderate intensity training
Arm Title
Group 3
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Exercise Training
Intervention Description
High Intensity Interval Training Group
Intervention Type
Other
Intervention Name(s)
Moderate Intensity Exercise Training
Intervention Description
Moderate Intensity Training Group
Primary Outcome Measure Information:
Title
Dialysis Adequacy
Description
Kt/V
Time Frame
8 weeks
Title
6 Minute Walking Test
Description
Functional Capacity
Time Frame
8 weeks
Title
5X Sit-to-Stand Test
Description
Functional Capacity
Time Frame
8 weeks
Title
Kidney Disease Quality of Life-36
Description
Life Quality
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Scale
Description
Mild depression (11-17 points) Moderate depression (18-29 points) Severe depression (30-63 points)
Time Frame
8 weeks
Title
Visual Analogue Scale
Description
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)
Time Frame
8 weeks
Title
Quadriceps muscle strength
Description
Muscle testing with dynamometer
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul University- Cerrahpasa
City
Istanbul
ZIP/Postal Code
34500
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intradialytic High-Intensity Interval Training in Hemodialysis Patients
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