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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Disease
• Intervention / Treatment: Other: Intradialytic exercise

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ozal Keles, Master; Phone Number: +90 5539602252; Email: okeles@biruni.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Istanbul Medipol University
    • Contact: Ozal Keles; Email: okeles@biruni.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control Group; No intervention
EXPERIMENTAL: Intradialytic exercise in hemodialysis patients ( Experimental Group); Intradialytic exercise group	Other: Intradialytic exercise; Intradialytic exercise group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
6 min walking test	6 minute
Kidney Disease Quality of Life-36 Scale	10 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory		5 minute
Visual Analog Scale	Fatigue	1 minute

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Collaborators: Medipol University
• Investigators: Principal Investigator: Özal Keleş, Student

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (ACTUAL): February 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; depression; chronic kidney disease; functional capacity; intradialytic exercise
• Other Study ID Numbers: Intradialytic Exercise

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No