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

NCT05534542 | Completed

• 1 other identifier: cngztaskaya
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication

Keywords

hemodialysis; dialysis efficiency; fatigue; quality of life; sleep; functionality

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Piper Fatigue Scale

  Two months

• Hospital Anxiety and Depression Scale (HADS)

  Two months

• Pittsburgh Sleep Quality Index (PSQI)

  Two months

• Tinetti Gait and Balance Test

  Two months

Study Arms (2)

core stabılızatıon

ACTIVE COMPARATOR

use of ıntradıalıtıc core stabılızatıon ın hemodıalysıs patıents

Other: exercıse

aerobıc exercıse

ACTIVE COMPARATOR

use of ıntradıalıtıc aerobıc exercıse ın hemodıalysıs patıents

Other: exercıse

Interventions

exercıse OTHER

ıntradıalıtıc core stabılızatıon

aerobıc exercıse; core stabılızatıon

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Muş Alparslan University: lead

Study Sites (1)

Mus State Hospital

Muş, Muş, 49100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cengiz TAŞKAYA

  scholar

  PRINCIPAL INVESTIGATOR

• Buket Büyükturan

  scholar

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 9, 2022
• Study Start: August 1, 2022
• Primary Completion: August 5, 2022
• Study Completion: October 7, 2022
• Last Updated: June 4, 2024

Record last verified: 2023-03

Locations

TU (1)