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CTRI Number  CTRI/2023/07/055165 [Registered on: 13/07/2023] Trial Registered Prospectively
Last Modified On: 12/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Yoga To Improve The Lung Function Among Children With Visual Impairment.  
Scientific Title of Study   Assessment Of Factors Affecting The Lung Function Of Children With Visual Impairment And Role Of Yoga To Improve The Lung Function: A Randomized Waiting List Controlled Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sowjanya  
Designation  PhD Scholar 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Department of yoga &humanities, Swami Vivekananda Yoga Anusandhana Samsthana(SVYASA), prashanti kuteeram, Kalluballu Post, Anekal, Swami Vivekananda Rd, Jigani, banglore, Karnataka 560105 INDIA.

Bangalore
KARNATAKA
560105
India 
Phone  6304491170  
Fax    
Email  sowjanyamallempati8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  soubhagya laxmi 
Designation  Assistant professor 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana(SVYASA), Deemed to be university 
Address  Room No 1, First Floor, Avartana Building ,Department Of Yoga &Humanities, Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA) Prashanti Kutiram,Jigani-506105 Bengaluru,Karnataka.

Bangalore
KARNATAKA
560105
India 
Phone  9483852383  
Fax    
Email  mohantyslaxmi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  soubhagya laxmi 
Designation  Assistant professor 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA) 
Address  Room No 1, First Floor, Avartana Building ,Department Of Yoga &Humanities, Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA) Prashanti Kutiram,Jigani-506105 Bengaluru,Karnataka.

Bangalore
KARNATAKA
560105
India 
Phone  9483852383  
Fax    
Email  mohantyslaxmi@gmail.com  
 
Source of Monetary or Material Support  
Swami Vivekananda yoga Anusandana samstana, Deemed to be university, banglore-506105 
 
Primary Sponsor  
Name  Sowjanya Mallempati 
Address  Department Of Yoga &Humanities, Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA) Prashanti Kutiram,Jigani-506105 Bengaluru. 
Type of Sponsor  Other [Self Funded] 
 
Details of Secondary Sponsor  
Name  Address 
nil  Nill 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
sowjanya  Devnar school for the blind  1-10-122 to 125, Mayur Marg, Begumpet, Secunderabad - 500016
Hyderabad
TELANGANA 
06304491170

sowjanyamallempati8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
institutional ethics committee swami vivekananda yoga anusandhana samsthana (SVYASA), BANGLORE  Approved 
NOC FROM SCHOOL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H54||Blindness and low vision,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  wait-list control  they wait till the end of the intervention (3 months).continue their daily activities. 
Intervention  yoga  INTERVENTION GROUP: The yoga module consisting of loosening, breathing practices, asana , pranayama, and relaxation techniques will be given . 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  For RCT study
1. Children with age 12-16 years
2.Early (2-3yrs) visually impaired children
3.Children comes under Physically low active (Physical Activity Questionnaire for Adolescents (PAQ-A) will be used to assess physical activity levels among children with visual impairment. Final score ranged 1–5 points. According to the mean scale of the nine items in the questionnaire, physical activity level will be determined as low (≤2), moderate (>2 and ≤3), and high activity (>3)).
4.No prior exposure to yoga or any exercise six months prior to study
5.Able to understand English will be part of the study. 
 
ExclusionCriteria 
Details  children with
1. Any chronic disease related to lungs
2. Multiple impairment
3. Any injury restricting practice of yoga
4.Except visual impairment, any debilitating conditions like hearing impairment, physical disability (deformity of limbs) and chronic psychological disabilities will be excluded from the study.
5.Parents who are not willing to provide informed consent.
6. Subjects Under any medication will be excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
phase2:RCT study
Lung function : Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), FVC/FEV1 ratio, peak expiratory flow (PEF). 

Baseline assessment, & post intervention assessment(after 3 months of intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
phase2:RCT study
1. Body posture
2. Heart rate variability
3. Depression
4. Respiratory endurance
5. Respiratory muscle strength
6. Functional performance
7. Upper extremity muscle strength

phase1:comparative study

1. Physical activity
2. Body posture
3. Heart rate variability
4. Depression
5. Functional performance
6. Upper extremity muscle strength
7. Barriers to physical activity(among visually impaired group)
8. Demographic data, anthropometric measurements, socioeconomic status will be measured



 
phase2:RCT study
baseline assessment, post intervention assessment(after 3 months of intervention).

physical activity , demographic data, anthropometric measurements, socioeconomic status will be measured at baseline.





phase1:Comparative study
one-time assessment.
 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   31/07/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Scientific evidence shows that visually impaired children and adolescent not practicing sport has much lower values than the standard/predicted values of FVC, FEV1, MVV and at the same time children with visual impairment who are into performance sport has significantly higher (p ≤ 0.01) values than the standard values of FVC, FEV1 and PEF (Rusu et al., 2020) . A study done on impaired children says the visually impaired adolescent group has a significantly low level of vital capacity compared to the counter group (Zebrowska, Gawlik, et al., 2007). Although the physically active visually impaired  subjects has good lung capacity, children with visual impairment are not reaching the WHO recommendations of 60-minute  daily moderate-to-vigorous physical activity (Haegele et al., 2018; Qi et al., 2020). Though factors like low physical activity, postural deviation (de Pádua et al., 2018), depression (Augestad, 2017) are more prominent in children with visual impairment , to the best of our knowledge there are no studies related to  contributing factors of poor lung function among them. So, in our present study we are aiming to find out the contributing factors for poor lung function in children with visual impairment (comparative study). To improve the lung function we are going to develop and validate a yoga module specially designed for children with visually impaired. After feasibility test same module will be used for RCT study. To the best of our knowledge studies done till now yoga as an intervention are not strong enough to generalize the results related to the lung function among children with VI. In our present study we are aiming to fulfill this gap by conducting study on children with visual impairment.




 
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