| CTRI Number |
CTRI/2025/02/080913 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effects of mind body exercise on attention level in middle age obese individual |
|
Scientific Title of Study
|
Effects of integration of Pilates exercise in dual task training on cognition in midlife obesity A Randomized control trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room No 105, First Floor Centre for Physiotherapy and
Rehabilitation Sciences, Jamia Millia Islamia, New Delhi
New Delhi
New Delhi
DELHI
110025
India |
| Phone |
09868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room No 105, First Floor Centre for Physiotherapy and
Rehabilitation Sciences, Jamia Millia Islamia, New Delhi
New Delhi
New Delhi
DELHI
110025
India |
| Phone |
09868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Khurshida Bano |
| Designation |
MPT Student |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room No 208, Second Floor Centre for Physiotherapy and
Rehabilitation Sciences, Jamia Millia Islamia, New Delhi
New Delhi
New Delhi
DELHI
110025
India |
| Phone |
7505906247 |
| Fax |
|
| Email |
khurshidabano21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Okhla, New Delhi 110025
|
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi- 110025
|
| Type of Sponsor |
Government funding agency |
|
|
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 Majumi M Noohu |
Jamia Millia Islamia |
Room No 201 PHD Lab
Centre for
Physiotherapy and
Rehabilitation Sciences,
Jamia Millia Islamia,
New Delhi- 110025
New Delhi
DELHI |
09868023378
mnoohu@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jamia Millia Islamia New Delhi 110025 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F04||Amnestic disorder due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Normal day to day activities |
| Comparator Agent |
General Physical - Cognition exercise |
50 minutes with each exercise of 3 sets of 20- 30 repetitions for 8 weeks of duration with 3 sessions in a week. |
| Intervention |
Pilates-cognition exercise |
50 minutes/session with a 5-minute warm-up followed by 40 minutes of exercise and a 5-minute cool-down for 8 week duration with 3 days session per week.
(2 sets of 15-20 repetition for each exercise) |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
MMSE Score more than 26
MoCA Score more than 25
BMI more than 25
WHR more than 0.80 in males and 0.90 in females
IPAQ score with light to moderate active individuals |
|
| ExclusionCriteria |
| Details |
Previous neurological disease
Diabetes and hypertension
Severe Musculoskeletal problems
Patients taking Medication which alter cognition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cognition( attention using P300 and executive function using Trail Making Test). |
Baseline and at 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lower limb strength (30s chair sit to stand test)
Functional Mobility ( Tug-cognition test) |
Baseline & at 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 3 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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)
|
Open to Recruitment |
| 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
|
Midlife Obesity has shown direct effects on cognition decline, which could predispose to dementia and Alzheimer disease later in life. Specific correlations with p300 amplitude and latency have been seen in cognition decline in this population. Along with cognition obese individuals have decreased lower limb functional strength. Various strategies have been effective in treating cognitive decline of which dual task training has shown significant differences, but as dual task involve strength training or aerobic exercise as a motor component along with cognitive task, middle age group show less adherence to these exercise. Whereas Pilates have shown increased adherence in these population along with significant individual effects on cognition level and lower limb strength improvement. Thus integrating Pilates exercise as a motor task in dual task paradigm may result in significant improvements. To the best of my Knowledge no such study has evaluated the effects of pilates with dual task paradigm in obese population. All the subjects will be informed about the nature, purpose, and possible risks involved in the study
and an informed written consent will be taken from them prior to participation. All the subjects will be
selected based on the inclusion criteria. Subjects will be familiarised with the intervention after dividing into either of three groups, Pilates -cog, General physical -cog exercise and control group. Pre and post measures will be taken after two months of intervention. Overall the study will provide the effects of pilates in dual task paradigm compared with general physical-cog exercise and control group on cognition and lower limb functional strength. |