| CTRI Number |
CTRI/2024/08/072618 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Improvement in strength of abdominal muscle with different modes of exercises. |
|
Scientific Title of Study
|
Effectiveness of static abdominal exercises versus dynamic abdominal exercises on strength and posture among normal healthy individuals. |
| 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 Daxa Mishra |
| Designation |
Professor |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
Dept no 152
K M Patel Institute of Physiotherapy,
Bhaikaka University
Karamsad
Anand
GUJARAT
388001
India
Anand
GUJARAT
388325
India |
| Phone |
9913086318 |
| Fax |
|
| Email |
daxagm@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jalpa Kansara |
| Designation |
MPT 2nd year student |
| Affiliation |
K M Patel Institute of Physiotherapy Karamsad |
| Address |
Dept no 152
K M Patel Institute of Physiotherapy Bhaikaka University
Karamsad
Anand
GUJARAT
388001
India
Anand
GUJARAT
388325
India |
| Phone |
9638012100 |
| Fax |
|
| Email |
jalpakansara976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jalpa Kansara |
| Designation |
MPT 2nd year student |
| Affiliation |
K M Patel Institute of Physiotherapy Karamsad |
| Address |
Dept no 152
K M Patel Institute of Physiotherapy Bhaikaka University
Karamsad
Anand
GUJARAT
388001
India
Anand
GUJARAT
388325
India |
| Phone |
9638012100 |
| Fax |
|
| Email |
jalpakansara976@gmail.com |
|
|
Source of Monetary or Material Support
|
| K M Patel Institute of Physiotherapy
Bhaikaka University
Karamsad
Anand, 388325
Gujarat |
|
|
Primary Sponsor
|
| Name |
K M Patel Institute of Physiotherapy |
| Address |
Bhaikaka University,
Karamsad, Anand 388325 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Daxa Mishra |
Shree Krishna Hospital |
Dept no 152
K M Patel Institute of Physiotherapy Bhaikaka University
Karamsad
Anand
GUJARAT
388001
India
Anand
GUJARAT |
09913086318
daxagm@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE 2, Bhaikaka University, Karamsad,Anand, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Weak abdominal strength |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Abdominal muscles strength will be assessed using Pressure Biofeedback Unit and postural curve for the lumbar spine will be measured using Flexicurve Ruler. |
Pressure biofeedback is the equipment which will be used to assess the strength of the abdominal muscle through the pressure exerted. Alteration of postural curve for the lumbar spine if any will be measured using Flexicurve Ruler in degree. |
| Intervention |
Outcomes like strength of abdominal muscle and postural alteration will be measured in static abdominal exercises group and dynamic abdominal exercises group using Pressure Biofeedback unit for strength and Flexicurve Ruler for the postural curve respectively |
Static and Dynamic abdominal exercises will be perform with 10 repetitions, twice a day (one time as home program) for 5 days in a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Normal Healthy adults whose abdominal Manual Muscle Testing Grade less than 5
Age 20 to 45 years
Both genders Male and Female
Person with normal Body Mass Index that is 18.5 to 22.9 kilogram per meters square |
|
| ExclusionCriteria |
| Details |
Previous surgery to the lumbar and abdominal surgery, Diastasis recti, Disc herniation, Pregnancy and Low back pain. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pressure Biofeedback Unit and Flexicurve Ruler |
before, and at 2 weeks and 4 weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MMT grading |
before, and at 2 weeks and 4 weeks of intervention. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
23/08/2024 |
| 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 Applicable |
| 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 will be beneficial for those whose abdominal muscle strength is weak and who are not able to do dynamic abdominal exercises after altered normal physiology of the muscle. So, in such situation static abdominal exercises can be prescribed in regular practice in clinics to maintain abdominal strength. |