| 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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H54||Blindness and low vision, |
|
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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 |
|
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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.
|
|
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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.
|