| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pediatric Kidney Disease Physical Activity Exercise Addiction | Other: study group Other: control group | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison of the Effectiveness of Virtual Reality and Video Assisted Exercises in Pediatric Chronic Kidney Disease. |
| Actual Study Start Date : | July 30, 2018 |
| Estimated Primary Completion Date : | November 28, 2020 |
| Estimated Study Completion Date : | December 28, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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.
|
Other: study group
The treatment protocol will consist of Nintendo wii fit virtual reality exercises (yoga,aerobic exercises,muscle strengthening exercises)
Other Name: virtual reality based therapy -aerobic exercises, stretching exercises
|
|
Active Comparator: 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.
|
Other: control group
The treatment protocol will consist of home based video exercises ;yoga,aerobic exercises,muscle strengthening exercises
Other Name: home based video exercise group
|
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.
| Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Irmak Çavuşoğlu, MSc | +905346028050 | irmak.cavusoglu@acibadem.edu.tr | |
| Contact: Devrim Tarakci, Ass.Prof. | +905322052282 | dtarakci@medipol.edu.tr |
| Turkey | |
| Istanbul University of Health Sciences Kanuni Sultan Süleyman Training and research Hospital | Recruiting |
| Istanbul, Küçükçekmece, Turkey, 34752 | |
| Contact: Sevgi YAVUZ, ASSOC. PROF | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 1, 2019 | ||||||||
| First Posted Date ICMJE | July 8, 2019 | ||||||||
| Last Update Posted Date | August 5, 2020 | ||||||||
| Actual Study Start Date ICMJE | July 30, 2018 | ||||||||
| Estimated Primary Completion Date | November 28, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparison of the Effectiveness of Virtual Reality and Video Assisted Exercises in Pediatric Chronic Kidney Disease. | ||||||||
| Official Title ICMJE | Comparison of the Effectiveness of Virtual Reality and Video Assisted Exercises in Pediatric Chronic Kidney Disease. | ||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
20 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 28, 2020 | ||||||||
| Estimated Primary Completion Date | November 28, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 6 Years to 18 Years (Child, Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Turkey | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04010981 | ||||||||
| Other Study ID Numbers ICMJE | 10840098-604.01.01-E.30224 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Irmak ÇAVUŞOĞLU, Acibadem University | ||||||||
| Study Sponsor ICMJE | Acibadem University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Acibadem University | ||||||||
| Verification Date | August 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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