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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05246956
Other study ID # Intradialytic Exercise
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 1, 2022

Study information

Verified date June 2021
Source Istanbul Medipol University Hospital
Contact Ozal Keles, Master
Phone +90 5539602252
Email okeles@biruni.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Chronic renal failure (CKD) is defined as a chronic, progressive degeneration in the kidney's fluid-electrolyte balance 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. CRF is divided into five stages according to the glomerular filtration rate. Stage V is end-stage renal disease (ESRD), a life-threatening condition in which GFR falls below 15 ml/min/1.73 m2. ESRD patients have to receive dialysis [hemodialysis (HD), peritoneal dialysis (PD)] or kidney transplantation (Tx) under the name of renal replacement therapies (RRT) in order to survive and to support the metabolic hemostatic function of the kidney. Although the majority of ESRD patients survive on dialysis, their quality of life and functional capacity are reduced due to uremic cardiomyopathy, cardiovascular diseases, anemia, diabetes mellitus, bone diseases, deconditioning, fatigue, weakness, inactivity and accompanying psychological problems. In addition, due to the burden of chronic disease and the necessity of being dependent on machinery, patients are also faced with the risk of losing their job, addiction in daily life activities, depression, anxiety, changes in body image, financial problems, sexual problems, social isolation, mortality and hospitalization. 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. Patients' choice of exercise depends on individual factors such as medical history, physical capacity, and transportation options, which are associated with cost and overall preferences. In this context, exercise programs during dialysis and at home are more preferred by patients due to the lack of transfer problems and loss of time. The exercise rehabilitation program to be chosen should also have features such as being practical, low cost and sustainable for patients receiving dialysis. Intradialytic exercise is a common recommendation to encourage patients to be physically active. Previous studies have shown that intradialytic exercise can reduce the severity of fatigue, improve sleep quality, increase exercise tolerance, improve life He claimed that it was effective in improving the quality of life and even improving the psychological state. Patients typically undergo two or three hemodialysis sessions per week, with each session lasting approximately 4 hours. As many patients maintain bed rest during hemodialysis sessions, intradialytic exercise can be a potentially useful approach to improve their health without spending extra time in the interdialytic period. Although exercise variety is limited during hemodialysis sessions, intradialytic exercise maximizes the use of HD time. In addition, intradialytic exercise has been reported to increase patient compliance. However, conflicting data on the effects of intradialytic exercise have been reported. Intradialytic exercise (IDE) is not yet a routine practice for hemodialysis patients, an important reason is the lack of guidelines to support it. Intradialytic exercise is rarely given as standard of care, although numerous small studies have demonstrated the multiple benefits and safe practice of intradialytic exercise training for patients with end-stage renal disease. The aim of our study is to investigate the effect of intradialytic exercises on functional capacity and quality of life, although it is known that it can be done without spending extra time and is more preferred by patients, which is not routinely applied and needs more studies on its effects.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Having stage 5 (ESRD) CRF according to GFR - Being between 20-80 years old - Ability to read and write - Being cooperative - Dialysis treatment for at least three months - Willingness to participate in the research Exclusion Criteria: - History of myocardial ischemia in the last 6 months - Uncontrolled diabetes mellitus and hypertension - heart failure - Having a malignant disease, - Having mental retardation, - illiteracy, - Not being cooperative - Having neurological or orthopedic disability.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Intradialytic exercise
Intradialytic exercise group

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6 min walking test 6 minute
Primary Kidney Disease Quality of Life-36 Scale 10 minute
Secondary Beck Depression Inventory 5 minute
Secondary Visual Analog Scale Fatigue 1 minute
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