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

NCT ID: NCT04010981

Last Updated: 2022-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-30

Study Completion Date

2021-10-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Kidney Disease Physical Activity Exercise Addiction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

study group

Intervention Type OTHER

The treatment protocol will consist of Nintendo wii fit virtual reality exercises (yoga,aerobic exercises,muscle strengthening exercises)

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.

Group Type ACTIVE_COMPARATOR

control group

Intervention Type OTHER

The treatment protocol will consist of home based video exercises ;yoga,aerobic exercises,muscle strengthening exercises

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

study group

The treatment protocol will consist of Nintendo wii fit virtual reality exercises (yoga,aerobic exercises,muscle strengthening exercises)

Intervention Type OTHER

control group

The treatment protocol will consist of home based video exercises ;yoga,aerobic exercises,muscle strengthening exercises

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

virtual reality based therapy -aerobic exercises, stretching exercises home based video exercise group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Acibadem University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Irmak ÇAVUŞOĞLU

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Istanbul, Küçükçekmece, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10840098-604.01.01-E.30224

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Virtual Reality in Chronic Neck Pain
NCT06549166 NOT_YET_RECRUITING NA