| CTRI Number |
CTRI/2024/11/076950 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Yoga and Core exercises on lung capacity in children with asthma |
|
Scientific Title of Study
|
Effect of Yogic Practice versus Core Stabilisation Exercises on Functional Capacity in children with Asthma: A Randomised Clinical 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 |
Aishwarya Nair |
| Designation |
PhD Scholar, Assistant Professor |
| Affiliation |
|
| Address |
Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangalore 575018, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8879315671 |
| Fax |
|
| Email |
nair.22phdpt101@student.nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Aishwarya Nair |
| Designation |
PhD Scholar, Assistant Professor |
| Affiliation |
|
| Address |
Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangalore 575018, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8879315671 |
| Fax |
|
| Email |
nair.22phdpt101@student.nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Nair |
| Designation |
PhD Scholar, Assistant Professor |
| Affiliation |
|
| Address |
Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangalore 575018, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8879315671 |
| Fax |
|
| Email |
nair.22phdpt101@student.nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangalore - 575018, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy NITTE Deemed to be University |
| Address |
Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangalore -575018, Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Aishwarya Nair |
Dakshina Kannada |
Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangalore -575018, Karnataka, India
Dakshina Kannada
KARNATAKA |
8879315671
nair.22phdpt101@student.nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NITTE (Deemed to be University), Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J453||Mild persistent asthma, (2) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CORE STABILISATION EXERCISES |
Intervention - Week Form of Exercise Set/Rep
1 Contracting abdominal muscles, supine position (first level)
Contracting abdominal muscles, prone position (first level)
Contracting abdominal muscles, cat position (first level) 3 sets, 20 repetitions
2 Contracting abdominal muscles, supine position (first level)
Contracting abdominal muscles, prone position (first level)
Contracting abdominal muscles, cat position (first level) 3 sets, 20 repetitions
3 Contracting abdominal muscles, supine position, one leg stretched (second level)
Contracting abdominal muscles, prone position with one leg stretched and the other leg bent at the
knee (second level)
Side bridge (second level) 3 sets, 10 repetitions
4 Bending 45 degrees to the left or right (second level)
Leaning forward (second level)
Back lunges (second level)
Lifting the leg, lying on its side (second level) 3 sets, 15 repetitions
5 Straighten one leg, bend other knees, supine position (second level)
Abduction of one leg, knees bent, supine position (second level)
Lifting the pelvis, supine position, knees on the floor (second level)
Lifting a straight leg lying on its side (second level) 3 sets, 20 repetitions
6 Raise one leg, knees bent, supine position (third level)
Moving one leg from behind, cat position (level three)
Bridging by lifting the body (third level)
Bending forward with straight arms at the side of the body (third level) 3 sets, 10 repetitions
7 Back lunge with straight arms beside the body (Level 3)
Lifting one leg, bending one knee, lying on the side (third level)
Straighten the leg, bending one knee, and supine position (level 3)
Hip abduction, bending one knee, and supine position (level 3) 3 sets, 15 repetitions
8 Lifting the pelvis and legs off with extended knees (third level)
Lifting two legs straight, knees lying on the side (third level)
Straightening the opposite arm and leg in the cat position (third level)
Bridging by extending one knee lying on the back (third level) 3 sets, 20 repetitions
|
| Comparator Agent |
Yogic Practice |
Comparator agent - The following yogic practices will be administered for 45 minutes each session, 3 times a week for 8 weeks, as given as below:
1. Sukshma Vyayama (for 5 min): Breathing exercises, vaksa-sthala-shakti- vikasaka (strengthening the chest), and udara-sakti-vikasaka (strengthening the abdominal muscles)
2. Asanas (for 20 min): Shavasana, Padmasana, Vajrasana, Gomukhasana, Ardha matsyendrasana, Mandukasana, Bhujangasana, Supta Pavanamuktasana, Chakrasana, Dhanurasana, Shavasana
3. Pranayama (for 10 min): Nadi Shodhan Pranayam, Bhramari Pranayam
4. Dharna and Dhyana (for 10 min): Udgita Pranayama
|
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of both sexes between the age 9 to 12 years diagnosed with Asthma diagnosed by a clinician.(2)
2. Children with Asthma classified as Moderate Asthma (defined as asthma that is well controlled with low or medium dose of Inhaled Corticosteroids/ Long-Acting Beta Agonists) or Mild Asthma (defined as asthma that is well controlled with as-needed Inhaled Corticosteroids or Short Acting Beta Agonists) as per the GINA guidelines will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1. Children classified as Severe Asthma as per the GINA guidelines will not be included in the study.
2. Immunotherapy, chronic medication use, or the history of chronic respiratory disease other than asthma.
3. An asthma exacerbation and/or upper respiratory tract infection within 4 weeks prior to study inclusion.(23)
4. Participants started on medications for 2 weeks before inclusion and/or initiating medications after study enrolment will not be included
5. Children with cognitive disorders that hinder their ability to follow commands.
6. Children with congenital heart diseases and skeletal malformations will also be excluded.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function test (PFT) |
Pre-intervention
Mid-intervention
Post-intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Six-Minute Walk Test (6MWT) |
Pre-intervention
Mid-intervention
Post-intervention |
| Paediatric Asthma Diary (PAD) |
Pre-intervention
Mid-intervention
Post-intervention |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To determine the effect of Yogic Practice on functional capacity and control of breathlessness in children diagnosed with Asthma To determine the effect of Core Stabilisation Exercises on functional capacity and control of breathlessness in children diagnosed with Asthma To compare the effects of Yogic Practice and Core Stabilisation exercises on functional capacity and control of breathlessness in children diagnosed with Asthma
|