- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513298
Structured Wii Aerobic Protocol on Reaction Time and Pulmonary Functions in Over Weight School- Aged Children
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 11571
- Recruiting
- Outpatient Clinics of Universities and Private Medical Centers in Cairo
-
Contact:
- Mohamed Zidan
- Phone Number: 01016469801
- Email: drmohzidan2015@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- School age children 10-15 years.
- Both gender.
- Diagnosed with over weight with Body mass index (BMI) is at or above the 85th percentile but less than 95th percentile for age , gender and height.
- All participants and parents/guardians were familiar with possible risks associated with the experimental procedures and signed a consent form to participate in the study.
Exclusion Criteria:
- Dysfunction restricting activity, such as neurological disorders.
- Pulmonary disorders such as COPD and malignancy.
- Unstable vital signs.
- Orthopedic problems such as scoliosis and kyphosis.
- Visual and hearing impairments.
- Brain injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Chest physical therapy and diet therapy
School age children who will receive routine chest physical therapy and diet therapy
|
Chest Physiotherapy: Breathing exercises (diaphragmatic breathing, segmental breathing) Incentive spirometry (if applicable) Thoracic expansion exercises Diet therapy : Individualized calorie-controlled diet plan |
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Experimental: Chest physical therapy along with wii aerobic exercises and diet therapy
School age children who will receive routine chest physical therapy along with wii aerobic exercises and diet therapy
|
Chest Physiotherapy: Breathing exercises (diaphragmatic breathing, segmental breathing) Incentive spirometry (if applicable) Thoracic expansion exercises Diet therapy : Individualized calorie-controlled diet plan
The Nintendo Wii Fit operates on the Wii system, produced by Nintendo Co., Ltd, based in Kyoto, Japan.
Among its features is a collection of interactive video games that require players to embody their on-screen character using a compact, wireless controller capable of motion detection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced vital capacity (FVC)
Time Frame: pre and post 36 sessions ( 3 sessions/week ) for 3 months
|
The maximum amount of air expired after the maximum Inspiration in liters.
|
pre and post 36 sessions ( 3 sessions/week ) for 3 months
|
|
Forced expiratory volume in 1 s (FEV1)
Time Frame: Pre and post 36 sessions ( 3 sessions/week) for 3 months
|
The air volume expired in the first second after maximal Inspiration in liters.
|
Pre and post 36 sessions ( 3 sessions/week) for 3 months
|
|
Peak expiratory flow (PEF)
Time Frame: Pre and post 36 sessions ( 3 sessions /week ) for 3 months
|
Achieving maximum forced expiration without hesitation from the point of peak lung inflation yields the maximum expiratory flow
|
Pre and post 36 sessions ( 3 sessions /week ) for 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chest Expansion
Time Frame: Pre and post 36 sessions ( 3 sessions / week ) for 3 months
|
Upper chest expansion (2nd intercostal space) & Lower chest expansion (xiphoid) were assessed from the reference point mentioned by using tab
|
Pre and post 36 sessions ( 3 sessions / week ) for 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-Minute Walk Test (6-MWT) ( To measure Functional Capacity )
Time Frame: Pre and post 36 sessions ( 3 sessions / week ) for 3 months
|
The children's submaximal functional capacity was evaluated by measuring the maximum distance they could walk in 6 min
|
Pre and post 36 sessions ( 3 sessions / week ) for 3 months
|
|
Timed Up and Go test (TUG) ( To measure Functional Capacity )
Time Frame: Pre and post 36 sessions ( 3 sessions / week ) for 3 months
|
This straightforward evaluation of a child's mobility includes static and dynamic balancing measures .It considers how long it takes for an individual to stand up from a chair, walk 3 m, turn around, and then sit back down
|
Pre and post 36 sessions ( 3 sessions / week ) for 3 months
|
|
Ruler Drop Test ( To measure reaction time )
Time Frame: pre and post 36 sessions ( 3 sessions / week ) for 3 months
|
The Ruler Drop Test is a simple clinical method used to assess reaction time.
A ruler is held vertically between the participant's thumb and index finger without contact.
The examiner releases the ruler unexpectedly, and the participant attempts to catch it as quickly as possible
|
pre and post 36 sessions ( 3 sessions / week ) for 3 months
|
|
Human Benchmark Reaction Time Test ( To measure reaction time )
Time Frame: pre and post 36 sessions ( 3 sessions / week ) for 3 months
|
The Human Benchmark Reaction Time Test is a computerized assessment that measures visual reaction time.
Participants are instructed to click (or tap) the screen as quickly as possible when a visual stimulus changes color (typically from red to green).
The reaction time is automatically recorded in milliseconds.
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pre and post 36 sessions ( 3 sessions / week ) for 3 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wii aerobic on reaction time
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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