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

Primary Purpose

Pediatric Kidney Disease, Physical Activity, Exercise Addiction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
study group
control group
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Kidney Disease focused on measuring Pediatric Chronic Kidney Disease,, virtual reality, physical therapy, exercise, Nintendo wii, Video based exercise

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Istanbul University of Health Sciences Kanuni Sultan Süleyman Training and research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study grup-Virtual reality- Nintendo Wii Fit exercise group

control group-home based video exercise group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 1, 2019
Last Updated
July 21, 2022
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT04010981
Brief Title
Comparison of the Effectiveness of Virtual Reality and Video Assisted Exercises in Pediatric Chronic Kidney Disease.
Official Title
Comparison of the Effectiveness of Virtual Reality and Video Assisted Exercises in Pediatric Chronic Kidney Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
October 28, 2021 (Actual)
Study Completion Date
October 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Kidney Disease, Physical Activity, Exercise Addiction
Keywords
Pediatric Chronic Kidney Disease,, virtual reality, physical therapy, exercise, Nintendo wii, Video based exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study grup-Virtual reality- Nintendo Wii Fit exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group-home based video exercise group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
study group
Other Intervention Name(s)
virtual reality based therapy -aerobic exercises, stretching exercises
Intervention Description
The treatment protocol will consist of Nintendo wii fit virtual reality exercises (yoga,aerobic exercises,muscle strengthening exercises)
Intervention Type
Other
Intervention Name(s)
control group
Other Intervention Name(s)
home based video exercise group
Intervention Description
The treatment protocol will consist of home based video exercises ;yoga,aerobic exercises,muscle strengthening exercises
Primary Outcome Measure Information:
Title
Muscle strength
Description
The strength of the lower and upper extremity muscles is measured with a digital dynamometer.
Time Frame
6 Weeks
Title
Functional Capacity-6-Minute Walking Test
Description
Functional capacity is assessed by 6 minute walk test at the baseline and after 6 weeks
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Fatigue
Description
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.
Time Frame
6 Weeks
Title
Quality of life MEASURE
Description
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.
Time Frame
6 Weeks
Title
Lung Parameters- Forced vital capacity (FVC), forced expiratory volume 1 second
Description
Lung Parameters are measured after 3 repetitive treatments performed by using a digital treatment.
Time Frame
6 Weeks
Title
Participation
Description
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.
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Istanbul University of Health Sciences Kanuni Sultan Süleyman Training and research Hospital
City
Istanbul
State/Province
Küçükçekmece
ZIP/Postal Code
34752
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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