NCT04010981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2021

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

3.2 years

First QC Date

July 1, 2019

Last Update Submit

July 21, 2022

Conditions

Pediatric Kidney DiseasePhysical ActivityExercise Addiction

Keywords

Pediatric Chronic Kidney Disease,virtual realityphysical therapyexerciseNintendo wiiVideo based exercise

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Fatigue

    6 Weeks

  • Quality of life MEASURE

    6 Weeks

  • Lung Parameters- Forced vital capacity (FVC), forced expiratory volume 1 second

    6 Weeks

  • Participation

    6 Weeks

Study Arms (2)

study grup-Virtual reality- Nintendo Wii Fit exercise group

EXPERIMENTAL

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

control group-home based video exercise group

ACTIVE COMPARATOR

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

Interventions

study groupOTHER

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

Also known as: virtual reality based therapy -aerobic exercises, stretching exercises
study grup-Virtual reality- Nintendo Wii Fit exercise group
control groupOTHER

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

Also known as: home based video exercise group
control group-home based video exercise group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, Küçükçekmece, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 8, 2019

Study Start

July 30, 2018

Primary Completion

October 28, 2021

Study Completion

October 28, 2021

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)