| CTRI Number |
CTRI/2024/05/066636 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Water-based Respiratory Muscle
Training |
|
Scientific Title of Study
|
Effect of Water-based Respiratory Muscle
Training in Normal Adults – A Randomized
Clinical Trail. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavankumar B N |
| Designation |
Physiotherapist |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education & Research |
| Address |
Department of physiotherapy
CARE Building
SDUAHER
Tamaka Kolar Karnataka
563103
Department of physiotherapy
Sri Devaraj Urs Academy of Higher Education and Research
Tamaka Kolar Karnataka
563103
Kolar
KARNATAKA
563103
India |
| Phone |
8073193089 |
| Fax |
|
| Email |
pavanbnvirat143@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil Kumar E |
| Designation |
Professor |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education & Research |
| Address |
Department of Physiotherapy
SDUAHER
Kolar
Karnataka
Sri Devaraj Urs Academy of Higher Education and Research
Tamaka Kolar 563103 Karnataka
department of physiotherapy
Kolar
KARNATAKA
563103
India |
| Phone |
7276408001 |
| Fax |
|
| Email |
sethilekumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pavankumar B N |
| Designation |
Physiotherapist |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education & Research |
| Address |
Department of Physiotherapy
SDUAHER
Kolar Karnataka
Sri Devaraj Urs Academy of Higher Education and Research
Tamaka Kolar Karnataka
department of physiotherapy
563103
Kolar
KARNATAKA
563103
India |
| Phone |
8073193089 |
| Fax |
|
| Email |
pavanbnvirat143@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy of Higher Education & Research Tamaka Kolar Karnataka INDIA pin code 563103 |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy of Higher Education & Research |
| Address |
Sri Devaraj Urs Academy of Higher Education & Research
(Deemed to be University)
kOLAR Karnataka 563103
Post Box 62, Tamaka, Kolar 563103, Karnataka
|
| 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 |
| Pavankumar B N |
RL Jalappa Hospital & Research Center (SDUAHER) |
Department of physiotherapy
RL JALAPPA Hospital and Research Center
Kolar Karnataka
563103
Kolar
KARNATAKA |
8073193089
pavanbnvirat143@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Faculty of allied health and basic sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Healthy Individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Land based Respiratory Muscle training. |
IN land ;
It is a form of resistance training that strengthens the muscles that we use to breathe. When inspiratory muscles are trained regularly for a certain period like a few weeks they adapt, becoming stronger and being able to work for a long period. also can able to do exercise more without getting so breathless. Procedure ï‚· The subject can sit or stand in an upright position. ï‚· Put on the nose clip ï‚· Hold the IMT by the hand grip. ï‚· Place the mouthpiece in the subject mouth, and make sure your lips make a good airtight seal. ï‚· Ask the subject to breathe out as far as he can, then ask him to take fast, forceful breaths of air through his mouth ask him to take as much as he can as quickly as possible while expanding the chest. ï‚· Breathe out slowly and with minimal effort, with the shoulder relaxed. ï‚· Wait for some time and take another fast, forceful breath in. ï‚· Repeat this fast, forceful breath as shown in the chart Remove the handle grip cover ï‚· Increase the resistance by turning the load adjustment clockwise one full turn, this will increase the level on the numbered scale by 1. ï‚· Replace the handle grip cover to use. ï‚· Increase the resistance every week by 1 turn. Cleaning the mouthpiece after every use. ï‚· Remove the mouthpiece and wash it in warm soapy water ï‚· Rinse under flowing water from the tap. ï‚· Shake off excess water and leave to air dry. Cleaning the power breathe ï‚· A few times a week, dismantle and soak your power breathe in warm water for 10 mins. ï‚· Wipe with a soft cloth under warm running water. ï‚· Shake off excess water and leave to air dry. Weakly sterilization will follow in every week |
| Intervention |
Water Based Respiratory muscle training |
In Water : It is a form of resistance training that strengthens the muscles that we use to breathe.
When inspiratory muscles are trained regularly for a certain period like a few weeks they adapt, becoming stronger and being able to work for a long period. also can able to do exercise more without getting so breathless.
Procedure
ï‚· The subject can sit or stand in an upright position.
ï‚· Put on the nose clip
ï‚· Hold the IMT by the hand grip.
ï‚· Place the mouthpiece in the subject mouth, and make sure your lips make a good airtight seal.
ï‚· Ask the subject to breathe out as far as he can, then ask him to take fast, forceful breaths of air through his mouth ask him to take as much as he can as quickly as possible while expanding the chest.
ï‚· Breathe out slowly and with minimal effort, with the shoulder relaxed.
ï‚· Wait for some time and take another fast, forceful breath in.
ï‚· Repeat this fast, forceful breath as shown in the chart
Remove the handle grip cover
ï‚· Increase the resistance by turning the load adjustment clockwise one full turn, this will increase the level on the numbered scale by 1.
ï‚· Replace the handle grip cover to use.
ï‚· Increase the resistance every week by 1 turn.
Cleaning the mouthpiece after every use.
ï‚· Remove the mouthpiece and wash it in warm soapy water
ï‚· Rinse under flowing water from the tap.
ï‚· Shake off excess water and leave to air dry.
Cleaning the power breathe
ï‚· A few times a week, dismantle and soak your power breathe in warm water for 10 mins.
ï‚· Wipe with a soft cloth under warm running water.
ï‚· Shake off excess water and leave to air dry.
Weakly sterilization will follow in every week
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
18 to 25 years all normal individuals free from all diseases both female and male |
|
| ExclusionCriteria |
| Details |
Subjects having Seizures, phobia towards water, respiratory problems, cardiac problems, an asthmatic patient, and subjects not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Maximum Inspiratory Pressure
|
Pre - 0 Week
Post- 4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BREATH HOLD TIME |
Base line & 4th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
14/05/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Suspended |
| 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
|
Water-based respiratory muscle training causes atmospheric pressure compression resulting in increased resistance to the respiratory muscles also provides a facilitator for enhancing lung expansion. Thus respiratory training in water will be an important therapy for respiratory patients. In order to trial this, first water-based training done on normal subjects which will aid in estimating the mean effect of water-based training on respiratory patients. Thus this study aimed to study the effect of water-based training in normal subjects as a Phase- 1 process. |