| CTRI Number |
CTRI/2021/10/037462 [Registered on: 21/10/2021] Trial Registered Prospectively |
| Last Modified On: |
13/10/2021 |
| 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
|
use of combined effect of physiotherapy and cognitive training to reduce risk of fall among elderly women with mild cognitive impairment |
|
Scientific Title of Study
|
Physiocognitive Training (PhyCogT) in Reducing the Risk of Fall Among Elderly Women with MCI |
| Trial Acronym |
PhyCogT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PREMNARAYAN KHICHI |
| Designation |
Phd Scholer |
| Affiliation |
ANANYA COLLEGE OF PHYSIOTHERAPY |
| Address |
402 /A
ARMAN HERITAGE BORISANA ROAD
RADHE SWEETS KALOL
KIRC campus Ahmedabad Mahesana Highway .opp.Sindbad Hotel kalol,382721
Gandhinagar
GUJARAT
382721
India |
| Phone |
9926478266 |
| Fax |
|
| Email |
prem_khichi@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSuresh Mani |
| Designation |
Head Physiotherapy Department |
| Affiliation |
LOVELY PROFESSIONAL UNIVERSITY |
| Address |
Lovely Professional University
Jalandhar - Delhi, Grand Trunk Road, Phagwara, Punjab 144001
Lovely Professional University CAMPUS.
Jalandhar - Delhi, Grand Trunk Road, Phagwara, Punjab 144001
Jalandhar
PUNJAB
144001
India |
| Phone |
9878331006 |
| Fax |
|
| Email |
suresh.22315@lpu.co.in |
|
Details of Contact Person
Public Query
|
| Name |
PREMNARAYAN KHICHI |
| Designation |
Phd Scholer |
| Affiliation |
ANANYA COLLEGE OF PHYSIOTHERAPY |
| Address |
402 /A
ARMAN HERITAGE BORISANA ROAD
RADHE SWEETS KALOL
KIRC Campus Ahmedabad Mahesaana Highway,Opp.Sindabad Hotel kalol 382721
Gandhinagar
GUJARAT
382721
India |
| Phone |
9926478266 |
| Fax |
|
| Email |
prem_khichi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| ADARSH MULTISPECIALITY HOSPITAL KIRC CAMPUS KALOL |
|
|
Primary Sponsor
|
| Name |
Premnarayan khichi |
| Address |
ANANYA COLLEGE OF PHYSIOTHERAPY
KIRC CAMPUS AHMEDABAD MAHESANA HIGHWAY KALOL |
| Type of Sponsor |
Other [self] |
|
|
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 |
| PREMNARAYAN KHICHI |
ADARSH MULTISPECIALITY HOSPITAL |
DEPARTMENT OF PHYSIOTHERAPY THIRD FLOOR.
Gandhinagar
GUJARAT |
9926478266
prem_khichi@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mild Cognitive Impaired women aged 60 years and above. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GRADED BALANCE TRAINING PROGRAM AND COGNITIVE TRAINING |
ONE GROUP WILL RECEIVE GRADED BALANCE TRAINING PROGRAM AND OTHER GROUP WILL RECEIVE COGNITIVE TRAINING.TOTAL DURATION OF TRAINING WILL BE 12 WEEKS |
| Intervention |
Physiocognitive training |
use of combined intervention including Balance and cognitive training .TOTAL DURATION OF TRAINING WILL BE 12 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 60 years or above.
2.MMSC Score ranging from 19-23 categorized as MCI.
3.Gender: only females are included in study.
4.Only ambulatory older adults, without an assistive device.
5.Person having history of fall at least once in past one year.
|
|
| ExclusionCriteria |
| Details |
1.Person had history of chronic alcoholism.
2.Brain trauma & lesion which interfere with cognitive performance.
3.Using medication which affects cognition.
4.Any condition contraindicated for any light to moderate exercise.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.fall rates |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.cognition
2.Balance
3.fear of falling
4.overall fall assessment
5.memory
6.executive funtion
7.gait speed
8.muscle strength
9.Quality of life
10. health status |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2021 |
| 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="22"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prem_khichi@rediffmail.com].
- For how long will this data be available start date provided 01-10-2021 and end date provided 30-04-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This RCT is designed to evaluate the relative effectiveness graded balance training programs and cognitive training as compared to Physiocognitive training and in improving risk of fall among elderly women with MCI |