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

NCT05246956 | Unknown

• 1 other identifier: Intradialytic Exercise
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Disease

Keywords

intradialytic exercise; chronic kidney disease; quality of life; depression; functional capacity

Outcome Measures

Primary Outcomes (2)

• 6 min walking test

  6 minute

• Kidney Disease Quality of Life-36 Scale

  10 minute

Secondary Outcomes (2)

• Beck Depression Inventory

  5 minute

• Visual Analog Scale

  1 minute

Study Arms (2)

Intradialytic exercise in hemodialysis patients ( Experimental Group)

EXPERIMENTAL

Intradialytic exercise group

Other: Intradialytic exercise

Control Group

NO INTERVENTION

No intervention

Interventions

Intradialytic exercise OTHER

Intradialytic exercise group

Intradialytic exercise in hemodialysis patients ( Experimental Group)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Medipol University: collaborator

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic; Depression

Condition Hierarchy (Ancestors)

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

Study Officials

• Özal Keleş

  Student

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozal Keles, Master

CONTACT

+90 5539602252; okeles@biruni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: experimental group control group

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: June 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 18, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)