| CTRI Number |
CTRI/2022/03/041482 [Registered on: 30/03/2022] Trial Registered Prospectively |
| Last Modified On: |
08/04/2023 |
| 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
|
A study to know the effect of Physical Therapy exercises on Cognition, physical strength, endurance and other physical functions in Elderly People |
|
Scientific Title of Study
|
Physical Therapy Interventions on Cognitive Frailty in Community Dwelling Elderly People: An Interventional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Tekwani |
| Designation |
Consulting Physiotherapist, PhD Scholar (Gujarat University) |
| Affiliation |
Gujarat University |
| Address |
Shiv Physiotherapy Centre
120, 121, First Floor, Avani Plaza, New Doctor House, Naroda, Ahmedabad
Ahmadabad
GUJARAT
38330
India |
| Phone |
8980450156 |
| Fax |
|
| Email |
agnanipooja01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Bhise |
| Designation |
Chief Physiotherapist, PhD guide (Gujarat University) |
| Affiliation |
Gujarat University |
| Address |
U N Mehta Institute of Cardiology & Research Centre,
Gate No, 1, Civil Hospital Rd, Haripura, Asarwa, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9427066624 |
| Fax |
|
| Email |
anjalibhise@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Tekwani |
| Designation |
Consulting Physiotherapist,PhD Scholar (Gujarat University) |
| Affiliation |
Gujarat University |
| Address |
Shiv Physiotherapy Centre
120, 121, First Floor, Avani Plaza, New Doctor House, Naroda, Ahmedabad
Ahmadabad
GUJARAT
382330
India |
| Phone |
8980450156 |
| Fax |
|
| Email |
agnanipooja01@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI MANILAL GANDHI VANPRASTHASHRAM |
|
|
Primary Sponsor
|
| Name |
Pooja Tekwani |
| Address |
B-702,Radhe Heights,near Safal Bunglows, Bhat, Gandhinagar- 382428 |
| 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 |
| Pooja Tekwani |
SHRI MANILAL GANDHI VANPRASTHASHRAM |
Near Cadila- Vatva Railway Crossing, Vitthal nagar Tekro, Opp. Railway quarters, Sub P.O G.I.D.C Vatva, Ahmedabad- 382445
Ahmadabad
GUJARAT |
8980450156
agnanipooja01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| NOC FROM MANILAL GANDHI VANPRASTHASHRAM |
Approved |
| The Institutional Ethics Committee, B.J. Medical College & Civil Hospital, Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cognitive Frailty |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Control group will only be given general advice to maintain their health. |
| Intervention |
Multicomponent exercise program consisting Aerobic exercises,Strength training, Balance training and Flexibility exercises for 12 weeks with 4 days/week with each session lasting for 30-45 minutes.
|
Aerobic exercises with moderate intensity will be conducted.
Muscle strengthening exercises involving all major muscle groups of the shoulder girdle and lower limb will be included.
Balance Exercises and slow static stretching will be included in each session.
Duration of the study is 12 weeks with 4 days/week with each session lasting for 30-45 minutes.
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Above 60 years of age group and willing to participate.
2.Participants who are cognitive prefrail and frail based on combined MOCA score and Frieds’s frailty criteria.
|
|
| ExclusionCriteria |
| Details |
1.Older adults with cardiopulmonary conditions
2.Having communication impairment
3.Having acute knee pain or pain in any weight bearing joint
4.Subjects with known cases of dementia or any other neurodegenerative diseases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cognitive Frailty (based on combined MOCA score and Frieds’s frailty criteria) |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
6 minute walk test
Lower extremity strength
Timed up and go test
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2022 |
| Date of Study Completion (India) |
24/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published an article titled : TRANSLATION, CULTURALADAPTATION AND VALIDATION OF GUJARATI
VERSION OF MONTREAL COGNITIVE ASSESSMENT (MOCA) IN OLDER ADULTS in Volume - 12 | Issue - 02 | February - 2023 of INTERNATIONAL JOURNAL OF SCIENTIFIC RESEARCH (IJSR) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomized, parallel group study designed to know the effect of Multicomponent exercise program on cognitive frailty in older adults. The study will be conducted at various elderly institutions of Ahmedabad. After taking baseline data the intervention group will recieve physical exercises in form of aerobic, strength, flexibility and balance training for 4 days/week for the duration of 12 weeks. the control group will be given advice to maintain their health. The primary outcome measure is cognitive frailty at 12 weeks. The secondary outcome measure is 6 minute walk test, lower limb strength and timed up and go test. |