Investigation of the Effect of Intradialytic Exercise on Functional Capacity,Quality of Life in Hemodialysis Patients

Renal Disease Clinical Trial

Official title:

Investigation of the Effect of Intradialytic Exercise on Functional Capacity and Quality of Life in Hemodialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246956
• Other study ID #: Intradialytic Exercise
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Renal Disease

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