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Completed

NCT Number: NCT05534542

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.

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Key information

Conditions

Hemodialysis Complication Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mus State Hospital

Muş, 49100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exercıse

Other

ıntradıalıtıc core stabılızatıon

Primary outcomes

  1. Dialysis adequacy

    Time frame: 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).

  2. Kidney Disease Quality of Life-36 (KDQOL-36)

    Time frame: 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).

  3. Five times sit-to-stand test

    Time frame: 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.

  4. 2 Minute Step Test

    Time frame: 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.

  5. 10 Metre Walk Test

    Time frame: 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 outcomes

  1. Piper Fatigue Scale

    Time frame: 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.

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  3. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Two months

    PSQI is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval.

  4. Tinetti Gait and Balance Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Muş Alparslan University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2022
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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