Comparıson of the effectıveness of ıntradıalıtıc Core stabılızatıon and aerobıc exercıse ın hemodıalysıs patıents

Sponsor

Muş Alparlan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05534542

Collaborator

(none)

Enrollment

Arms

2.2

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis Complication	Other: exercıse	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparıson of the effectıveness of ıntradıalıtıc Core stabılızatıon and aerobıc exercıse ın hemodıalysıs patıents

Anticipated Study Start Date :

Sep 5, 2022

Anticipated Primary Completion Date :

Sep 9, 2022

Anticipated Study Completion Date :

Nov 11, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Dialysis adequacy [one month]
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).
Kidney Disease Quality of Life-36 (KDQOL-36) [Two months]
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).
Five times sit-to-stand test [Two months]
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.
2 Minute Step Test [Two months]
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.
10 Metre Walk Test [Two months]
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.

Secondary Outcome Measures

Piper Fatigue Scale [Two months]
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.
Hospital Anxiety and Depression Scale (HADS) [Two months]
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.
Pittsburgh Sleep Quality Index (PSQI) [Two months]
PSQI is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval.
Tinetti Gait and Balance Test [Two months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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