| CTRI Number |
CTRI/2026/04/108974 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Impact of Brain Gym Exercises on Memory, Attention, and Mental Awareness After Menopause. |
|
Scientific Title of Study
|
The Effect of Brain Gym in
Domains of Cognition and Metacognition
in Post-menopausal Women. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abin Johnson |
| Designation |
Post Graduate Student |
| Affiliation |
Medical Trust Institute of Medical Sciences |
| Address |
MPT - Second Year,
Department of Physiotherapy,
6th Floor,
HOC Township Backside Road,
Irumpanam
Ernakulam
KERALA
682309
India |
| Phone |
9562878809 |
| Fax |
|
| Email |
abythephysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jerin K Issac |
| Designation |
Assistant Professor |
| Affiliation |
Medical Trust Institute of Medical Sciences |
| Address |
Department of Physiotherapy,
HOC Township Backside Road,
Irumpanam
Ernakulam
KERALA
682309
India |
| Phone |
7025946717 |
| Fax |
|
| Email |
mercyissac0@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anila Paul |
| Designation |
Professor |
| Affiliation |
Medical Trust Institute of Medical Sciences |
| Address |
Department of Physiotherapy,
HOC Township Backside Road,
Irumpanam
Ernakulam
KERALA
682309
India |
| Phone |
04842843502 |
| Fax |
|
| Email |
mtimsbpt@medicaltrusthospital.in |
|
|
Source of Monetary or Material Support
|
| Medical Trust Institute of Medical Sciences, Kochi, Kerala, India - 682309 |
|
|
Primary Sponsor
|
| Name |
Medical Trust Institute of Medical Sciences |
| Address |
HOC Township Backside Road,
Irumpanam, Kochi, Kerala, India - 682309 |
| Type of Sponsor |
Research institution |
|
|
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 Jerin Issac |
Association of Karunalayam |
Ground Florr,
Athani Mundapalam Rd, Kollamkudimugal Rd, Mundampalam, Kochi, Kerala 682021
Ernakulam
KERALA |
9562878809
abinjokottarathil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Trust Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R418||Other symptoms and signs involvingcognitive functions and awareness, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brain Gym Exercises |
Brain Gym exercises are a set of simple, gentle, and structured physical movements designed to stimulate brain function by enhancing coordination between the brain and body. These exercises aim to improve attention, memory, learning ability, concentration, and self-regulation by promoting integration between the left and right hemispheres, as well as improving focus and emotional balance.
Brain Gym activities typically involve cross-lateral movements, balance-based actions, breathing exercises, and relaxation techniques. They are easy to perform, require no special equipment, and can be adapted for different age groups. Due to their simplicity and safety, Brain Gym exercises are often used in educational, rehabilitative, and wellness settings to support cognitive performance and mental well-being. 5 sessions per week for 8 weeks |
| Comparator Agent |
Conventional Cognitive Protocol |
Conventional Cognitive Protocol consists of walking and generalised lower limb self stretching for same treatment duration based on literature reviews.5 sessions per week for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Postmenopausal women aged 50 to 65 years
2.Mild cognitive impaired with MoCA 18 to 25
3.Women with English proficiency
|
|
| ExclusionCriteria |
| Details |
1.Diagnosed with any major neurological issues
2.Severe joint or muscle problems that limit movement
3.Uncontrolled heart disease, diabetes, or high blood pressure
4.Currently in another cognitive program, under or post chemotherapy or Whole brain radiation therapy.
5.Difficulty in walking independently or with minimal support.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rey Auditory Verbal Learning Tool
Digit Span Test
Trial Making Test - B |
Baseline and Post Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Metacognitive Awareness Inventory |
Baseline and Post Intervention |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/04/2026 |
| 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)
|
Not Yet Recruiting |
| 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
|
This study is designed to evaluate the effect of Brain Gym exercises on cognitive function and metacognitive awareness in post-menopausal women. Menopause-related changes may affect memory, attention, and mental awareness, which can impact daily functioning and quality of life. Brain Gym exercises are simple, movement-based activities that aim to improve brain–body coordination and mental performance. In this interventional study, post-menopausal women with mild cognitive decline(MoCA score between 18 and 25)will participate in a structured Brain Gym exercise program for a 8 week duration. Cognitive function and metacognitive awareness will be assessed at baseline and after completion of the intervention using standardized assessment tools. The findings of this study may help establish Brain Gym exercises as a safe, non-invasive, and cost-effective approach for improving cognitive health in post-menopausal women. |