| CTRI Number |
CTRI/2024/06/068499 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see efect of braingym exercise along with breathing exercise to improve sleep quality on geriatric population and assess on pittsburgh sleep quality index scale |
|
Scientific Title of Study
|
A COMPARATIVE STUDY BY BRAIN GYM EXERCISE AND BREATHING EXERCISE
TO DETERMINE THE EFFICACY OF SLEEP QUALITY USING PITTSBURGH SLEEP QUALITY INDEX ON GERIATRICS PATIENTS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asmita Pradeep Badhe |
| Designation |
Intern |
| Affiliation |
Dr. Ulhas Patil College Of Physiotherapy Jalgaon |
| Address |
Department of Physiotherapy at Dr. Ulhas Patil college of Physiotherapy Khirdi Shivar, Tal And Dist Jalgaon Jalgaon MAHARASHTRA India
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
962378818 |
| Fax |
|
| Email |
asmitaapb21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitra Mridha |
| Designation |
Professor |
| Affiliation |
Dr. Ulhas Ptail College Of Physiotherapy Jlagaon |
| Address |
Department of Neurosciences PT at Physiotherapy OPD no. 207 Khirdi Shivar, Tal And Dist Jalgaon
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
9404702583 |
| Fax |
|
| Email |
pradipbadhe42@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chitra Mridha |
| Designation |
Professor |
| Affiliation |
Dr. Ulhas Ptail College Of Physiotherapy Jlagaon |
| Address |
Department of Neurosciences PT at Physiotherapy OPD no. 207 Khirdi Shivar, Tal And Dist Jalgaon
Jalgaon
MAHARASHTRA
425309
India |
| Phone |
9404702583 |
| Fax |
|
| Email |
pradipbadhe42@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Ulhas Patil college of physiotherapy , khirdi shivar NH 06 ,Tal a d district JALGAON pin code
425309 |
|
|
Primary Sponsor
|
| Name |
Asmita P Badhe self |
| Address |
Ayodhya Nagar Tal. And District Jalgoan
MAHARASHTRA
425309
INDIA |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Chitra Mridha |
Amar sahid sant kanwar ram trusts old age home |
Amar sahid sant kanwar ram trusts old age home Icchadevi square Tal and district Jalgaon
MAHARASHTRA
425309
Jalgaon
MAHARASHTRA |
9404702583
asmitaapb21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Dr. Ulhas Patil college of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brain gym exercise and Breathing exercise |
Brain gym exercises (includes Spot marching, Positive points, The active arms, Earth buttons, The energy yawns, Lazy eights, Gravity glider, Foot flex ) and breathing exercise (Diaphragmatic breathing, Pursed lip breathing, 4-7-8 breathing) .
and breathing exercise( includes Diaphragmatic breathing, Pursed lip breathing, 4-7-8 breathing) .
These protocol will be administered for 6 weeks and each exercise will be given for 5 repetitions (2sets). |
| Comparator Agent |
Brain gym exercise and Breathing exercise |
Group A and Group B |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with informed consent.
2.Both male and female between age group 65 and above
3.Old Aged subjects having sleep problems .
4.Participants who are willing to participate.
|
|
| ExclusionCriteria |
| Details |
1.Cognitive impairment
2.Visual impairments.
3.Neurological impairments
4.Psychological impairments.
5. Schizhoprenia
6.Known case of respiratory cardiovascular, metabolic and musculoskeletal disorder
7.Psychological disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pittsburgh sleep quality index |
6 weeks (daily) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PSQI |
After 6 weeks will be recorded |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/06/2024 |
| 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="0"
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
|
Ethical clearance will be obtained from institutional ethical committee and principal of Dr. Ulhas Patil college of physiotherapy, jalgaon. A written informed consent form will be obtained from subject who are willing to participate. Subjects will be screened according to inclusion and exclusion criteria. The procedure, aim and objective will be explained to willing participants.selected total 40 participants will be divided into two groups using simple random sampling or lottery method.A Pre and Post Interventional study was undertaken , participants were included by convenient sampling based on inclusion and exclusion criteria as mentioned earlier.The purpose and procedure of the study was explained to the participant.A written consent form was obtained from subjects.A brief demographic data of all patients was obtained.Participants were divided into two groups that is group A and Group B.Group A have 20 participants who will be treated with both Brain gym exercises (includes Spot marching, Positive points, The active arms, Earth buttons, The energy yawns, Lazy eights, Gravity glider, Foot flex ) and breathing exercise (Diaphragmatic breathing, Pursed lip breathing, 4-7-8 breathing) .And Group B also have 20 participants who will be treated with only breathing exercise( Diaphragmatic breathing, Pursed lip breathing, 4-7-8 breathing) .Participants performed Brain gym exercises and breathing exercises with 2 sets of 5 repetitions each for 6 weeks.Pre & post interventions outcome was recorded
|