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Clinical Trials/NCT04010981
NCT04010981CompletedNot Applicable

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

Acibadem University2 sites in 2 countries16 target enrollmentStarted: July 30, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
16
Locations
2
Primary Endpoint
Functional Capacity-6-Minute Walking Test

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
6 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Functional Capacity-6-Minute Walking Test

Time Frame: 6 Weeks

Functional capacity is assessed by 6 minute walk test at the baseline and after 6 weeks

Muscle strength

Time Frame: 6 Weeks

The strength of the lower and upper extremity muscles is measured with a digital dynamometer.

Secondary Outcomes

  • Lung Parameters- Forced vital capacity (FVC), forced expiratory volume 1 second(6 Weeks)
  • Quality of life MEASURE(6 Weeks)
  • Fatigue(6 Weeks)
  • Participation(6 Weeks)

Investigators

Sponsor
Acibadem University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Irmak ÇAVUŞOĞLU

Principal Investigator

Acibadem University

Study Sites (2)

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