| CTRI Number |
CTRI/2024/05/066606 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Connection And Relationship Of Backbone Hardness And Body Activity In Middle Aged To Old Aged Adults |
|
Scientific Title of Study
|
Comparison and Correlation of Lumbopelvic Stability and Physical Performance in Middle Aged to Old Aged Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreya Menezes |
| Designation |
Postgraduate student of physiotherapy |
| Affiliation |
AIIPMR Mumbai |
| Address |
Physiotherapy Department 2nd floor AIIPMR Mahalaxmi Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9167928876 |
| Fax |
|
| Email |
shmenezes2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Vaibhav Dolas |
| Designation |
Lecturer, Physiotherapy |
| Affiliation |
AIIPMR Mumbai |
| Address |
Physiotherapy Department, 2nd floor AIIPMR Mahalaxmi Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9820384812 |
| Fax |
|
| Email |
vsdolas21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vaibhav Dolas |
| Designation |
Lecturer, Physiotherapy |
| Affiliation |
AIIPMR Mumbai |
| Address |
Physiotherapy Department, 2nd floor AIIPMR Mahalaxmi Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9820384812 |
| Fax |
|
| Email |
vsdolas21@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Physical Medicine and Rehabilitation Mahalaxmi Mumbai-34 |
|
|
Primary Sponsor
|
| Name |
Shreya Menezes |
| Address |
Physiotherapy Department AIIPMR Mahalaxmi Mumbai |
| 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 |
| Dr Shreya Menezes |
All India Institute of Physical Medicine and Rehabilitation |
Room No 224 Physiotherapy Department All India Institute of Physical Medicine and Rehabilitation Mahalaxmi Mumbai
Mumbai
MAHARASHTRA |
9167928876
shmenezes2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIPMR MUMBAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals of age 41-80 years
Both males and females |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
41.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals of age 41 to 80 years
2. Individuals ambulatory without assistive device
3. Both Males and Females
4. BMI less than 32 kg/m2
5. Participants will be divided into four groups:
(I) Middle Age Group 1: Individuals of age 41 to 50 years
(II) Middle Age Group 2: Individuals of age 51 to 60 years
(III) Old Age Group 1: Individuals of age 61 to 70 years
(IV) Old Age Group 2: Individuals of age 71 to 80 years
|
|
| ExclusionCriteria |
| Details |
1. Orthopedic condition
2. Neurological condition
3. Cardiovascular condition
4. History of pregnancy during the last year
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Lumbopelvic stability measured using Pressure Biofeedback Unit expressed in mmHg.
2)Physical Performance-4 components
1. Gait speed expressed in meters per seconds (m/s)
2. Balance expressed in seconds
3. Lower body strength expressed as number of times to complete sit to stand in 30 secs
4. Aerobic endurance expressed as total distance in meters covered in 6 minutes walk
|
It is cross sectional study, observations recorded at one time so there are no time points |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
11/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/05/2024 |
| 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
|
Study Title - COMPARISON AND CORRELATION OF LUMBOPELVIC STABILITY AND PHYSICAL PERFORMANCE IN MIDDLE AGED TO OLD AGED ADULTS. Total Sample Size- 80. Inclusion criteria - 1) individuals of age 41 to 80 years 2) Individuals ambulatory without assistive device 3) Both males and females 4) BMI less than 32 kg/sq m 5) Participant - 4 groups- Gr I (41-50 yrs), Gr II (51-60 yrs), Gr III (61-70 yrs), Gr IV (71-80 yrs) Exclusion Criteria - 1) Orthopedic condition 2) Neurological condition 3) Cardiovascular condition 4) History of pregnancy during last year Participant giving informed consent will be included in the study. Participant will undergo study protocol. Data collected from the study will be statically analysed.
|