Comparison of the Effectiveness of Virtual Reality and Video Assisted Exercises in Pediatric Chronic Kidney Disease.

In this study, we aim to improve respiratory function and balance of decreased muscle strength, decrease fatigue values, improve quality of life, improve inflammation findings and GFR ( Glomerular filtration rate) values in pediatric chronic kidney patients with virtual reality exercise applications.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Exercise Addiction; Pediatric Kidney Disease
• Intervention / Treatment: Other: study group; Other: control group

Detailed Description

1.Group - Working group: Virtual reality technology (Nintendo Wii Fit Plus) exercise group 2.Group-Control group: home-based video games will be divided into groups that exercise.

Measurements of functional capacity, muscle strength, quality of life, depression, fatigue and physical activity levels, medical values (pulmonary function test values, inflammation level values, glomerular filtration rate level values) of both groups will be recorded before and after treatment.

In the study group treatment protocol; patients will complete 12 sessions of virtual reality exercise application-Nintendo Wii Fit Plus 30-minute training sessions with strengthening exercises for the lower extremities and upper extremities, aerobic and balance exercises. They will do 5 minutes warm-up exercises before the session and 5 minutes cool-down exercises as well as breathing exercises at the end of the session and will participate in a 50-minute treatment session in total.

In the control group treatment protocol, patients will follow the 30-minute video exercise practices for the lower and upper extremities that are similar to Nintendo Wii Fit exercises for the control group at home two days a week. exercises will complete the 50-minute training session. Apart from exercise sessions, patients will record their activities (walking, cycling, swimming…) in daily life forms with their own pedometers. Thus, changes in physical activity levels will be monitored.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Küçükçekmece
    • Istanbul, Küçükçekmece, Turkey, 34752
      • Istanbul University of Health Sciences Kanuni Sultan Süleyman Training and research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 6-18 years of age
• to be chronic kidney disease,
• to have chronic kidney disease at least 6 months
• to have no visual hearing impairment

Exclusion Criteria:

• Attending another exercise program,
• to have severe infection (sepsis, peritonitis)
• Having anorexia or other growth retardation,
• Mental retardation,
• Inadequate communication in Turkish,
• Failure to communicate,
• Cardiomyopathy,
• presence of angina pectoris,
• Standing and walking obstacle
• Presence of orthopedic problem
• Cerebrovascular disease
• Patients with lower limb amputation and not using orthosis-prosthesis,
• patients with metastatic carcinoma will not be included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: study grup-Virtual reality- Nintendo Wii Fit exercise group; in this group patients will complete 12 sessions of virtual reality exercise - Nintendo Wii Fit Plus, 30-minute training sessions with strengthening exercises for the lower extremities and upper extremities, aerobic and balance exercises, two days a week. They will do 5 minute warm-up exercises before stretching, stretching exercises and 5 minute cooling exercises at the end of the session, as well as breathing exercises and will attend a total of 50 minutes of treatment.	Other: study group; The treatment protocol will consist of Nintendo wii fit virtual reality exercises (yoga,aerobic exercises,muscle strengthening exercises); Other Names: virtual reality based therapy -aerobic exercises, stretching exercises
ACTIVE_COMPARATOR: control group-home based video exercise group; Patients will be join home based exercises two days a week during 12 sessions .we will prepare for the lower and upper extremity features similar to Nintendo Wii Fit exercises 30 minutes of video game exercise practices, 5 minutes warm-up exercises, 5 minutes cooling exercises and complete the 50-minute training session with the breathing exercises we will teach them. In addition to exercise sessions, patients will record their activities (walking, cycling, swimming ına) in daily life schedules with their pedometers. Thus, changes in physical activity levels will be monitored.	Other: control group; The treatment protocol will consist of home based video exercises ;yoga,aerobic exercises,muscle strengthening exercises; Other Names: home based video exercise group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	The strength of the lower and upper extremity muscles is measured with a digital dynamometer.	6 Weeks
Functional Capacity-6-Minute Walking Test	Functional capacity is assessed by 6 minute walk test at the baseline and after 6 weeks	6 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	The fatigue parameter is evaluated with the Pediatric Quality of Life Inventory Version 4.0 General Scales (PedsQL), a tool developed specifically to assess the physical, school, emotional, and social domains of health-related quality of life in children previously confirmed in healthy and patient populations. From the physical area of PedsQL individual elements of low energy level will be extracted from both child and parent questionnaires to assess the prevalence of fatigue. The frequency of low energy over the past month is classified as one of four categories: "never"; "hardly"; "sometimes"; "Often / almost always". Overall PedsQL scores, from 0 to 100, higher scores mean better quality of life. PedsQL is scored from the "low energy" item from both parents and child surveys.	6 Weeks
Quality of life MEASURE	PedsQLTM 4.0 Quality of Life Scale for Children is used to assess the quality of life of children. PedsQLTM 4.0, with a child / adolescent report and primary caregiver report, is a modular approach to measuring health-related quality of life in healthy children and adolescents in confirmed acute and chronic health conditions in Brazil. The questionnaire evaluates four scales (physical, emotional, social and school functioning) in 23 questions using age-specific forms. Self-report forms are available for children / adolescents aged 5-7, 8-12 or 13-18. Parental reports are available for children aged 2-4, 5-7, 8-12 or 13-18. The questionnaire score ranges from zero to 100 on each scale, and higher values are interpreted to indicate a better quality of life.	6 Weeks
Lung Parameters- Forced vital capacity (FVC), forced expiratory volume 1 second	Lung Parameters are measured after 3 repetitive treatments performed by using a digital treatment.	6 Weeks
Participation	Participation in the activity is assessed by Scope questionnaire.The Short Child Roller activities and tasks profile (SCOPE) test is a children-specific assessment test. SCOPE is a test that can be used in the age range from birth to 21 years, which evaluates activity participation as person-centered. SCOPE allows the assessment of participation with comparable objective data within the physical, mental and social disabilities of the child. This questionnaire consists of 25 questions and includes 4 questions from the areas of will, habits, interaction and communication skills, processing skills and motor skill activity performance, and 5 questions for the latest environment. High scores indicate good results. Children's participation in the activity and their level of entertainment depending on the activity; Short Child Roles Activities and Tasks Profile SCOPE Will and Habits are evaluated by comparing the scores of performance titles before and after treatment.	6 Weeks

Collaborators and Investigators

• Sponsor: Acibadem University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2018
• Primary Completion (ACTUAL): October 28, 2021
• Study Completion (ACTUAL): October 28, 2021

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (ACTUAL): July 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: exercise; virtual reality; physical therapy; Pediatric Chronic Kidney Disease,; Nintendo wii; Video based exercise
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 10840098-604.01.01-E.30224

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