Comparison of the Effectiveness of Intradialytic Core Stabilization and Aerobic Exercise in Hemodialysis Patients

Purpose: To examine the effects of core stabilization and aerobic exercises on dialysis adequacy, functionality level, and quality of life in hemodialysis (HD) patients. The secondary aim of the study is to compare the effectiveness of intradialytic core stabilization and aerobic exercises in HD patients.

Materials and Methods: Patients who received hemodialysis treatment for 4 hours, 3 days a week were planned to be included in this randomized controlled study. Patients participating in the study will be randomly divided into 2 groups. Grup 1 was planned to be given core stabilization exercises during hemodialysis three times a week for eight weeks; Group 2 was planned to be given aerobic exercise during hemodialysis three times a week for eight weeks. It aimed to evaluate the patients in the weeks before the start of the treatment and the week after the end of the treatment. Personal information form for evaluation, dialysis adequacy, quality of life questionnaire-kidney disease quality of life-36, piper fatigue scale, hospital anxiety and depression scale (hads), Pittsburgh sleep scale, five times sit and stand test, 10 m walking test , tinetti balance and walking test, and 2-minute step test were planned to be used.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication
• Intervention / Treatment: Other: exercıse

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Mus
    • Muş, Mus, Turkey, 49100
      • Mus State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• To receive HD treatment for a minimum of 6 months, for 4 hours per day, three days per week
• Being 18 years or older
• A score of 3 and/or below in the Sarcopenia Screening Test (SARC-F)

Exclusion Criteria:

• Having a history of myocardial infarction in the last 3 months
• Having angina pectoris, arrhythmia, or uncontrolled hypertension
• Having communication and/or cognitive issues that prevent them from meeting the requirements of the tests
• Becoming pregnant or going through infertility treatment
• Having a psychiatric diagnosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: core stabılızatıon; use of ıntradıalıtıc core stabılızatıon ın hemodıalysıs patıents	Other: exercıse; ıntradıalıtıc core stabılızatıon
Active Comparator: aerobıc exercıse; use of ıntradıalıtıc aerobıc exercıse ın hemodıalysıs patıents	Other: exercıse; ıntradıalıtıc core stabılızatıon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dialysis adequacy	Dialysis adequacy is determined as the urea reduction rate (URR) and unitless Kt/V value. In calculating the Kt/V value; K-is the urea clearance coefficient of the dialyzer (ml/min), t refers to dialysis time (min), and V signifies the urea distribution volume (ml).	one month
Kidney Disease Quality of Life-36 (KDQOL-36)	The KDQOL-36 is a measure of kidney disease-related quality of life that comprises four subscales: generic core [Physical Component Summary (PCS, 12 items) and Mental Component Summary (MCS, 12 items)]; Symptoms/Problems (12 items); Burden of Kidney Disease (4 items), and Effects of Kidney Disease (8 items).	Two months
Five times sit-to-stand test	The Five-Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements.	Two months
2 Minute Step Test	The test, known as the 2-minute step test (TMST), simply requires that tested individuals march in place as fast as possible for 2 minutes while lifting their knees to a height midway between their patella and iliac crest when standing.	Two months
10 Metre Walk Test	The 10 meter walk test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.	Two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Piper Fatigue Scale	The Piper Fatigue Scale (PFS) is one of the commonly used multidimensional fatigue measures and includes subdomains of behavioral, affective, sensory, and cognitive/mood attributes of fatigue.	Two months
Hospital Anxiety and Depression Scale (HADS)	The HADS was developed to detect states of anxiety and depression in hospitalized patients. The measure was designed to exclude items that might conflate anxiety or depression with physical health problems.	Two months
Pittsburgh Sleep Quality Index (PSQI)	PSQI is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval.	Two months
Tinetti Gait and Balance Test	The Tinetti assessment tool is an easily administered, task-oriented test that measures an adult's gait and balance abilities. To assess balance, the patient is seated in a firm, armless chair. stand next to the patient to evaluate the gait. The patient is asked to walk normally and then speed up.	Two months

Collaborators and Investigators

• Sponsor: Muş Alparlan University
• Investigators: Principal Investigator: Cengiz TAŞKAYA, scholar; Study Director: Buket Büyükturan, scholar

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): August 5, 2022
• Study Completion (Actual): October 7, 2022

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: fatigue; sleep; quality of life; functionality; hemodialysis; dialysis efficiency
• Other Study ID Numbers: cngztaskaya

Drug and device information, study documents

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