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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04010981
• Other study ID #: 10840098-604.01.01-E.30224
• Status: Completed
• Phase: N/A
• Start date: July 30, 2018
• Est. completion date: October 28, 2021

Study information

• Verified date: July 2022
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 28, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise Addiction
• Kidney Diseases
• Pediatric Kidney Disease
• Physical Activity
• Renal Insufficiency, Chronic

Intervention

Other:
• study group
The treatment protocol will consist of Nintendo wii fit virtual reality exercises (yoga,aerobic exercises,muscle strengthening exercises)
• control group
The treatment protocol will consist of home based video exercises ;yoga,aerobic exercises,muscle strengthening exercises

Locations

Country	Name	City	State
Turkey	Istanbul University of Health Sciences Kanuni Sultan Süleyman Training and research Hospital	Istanbul	Küçükçekmece

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength	The strength of the lower and upper extremity muscles is measured with a digital dynamometer.	6 Weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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