CTRI Number |
CTRI/2022/09/045924 [Registered on: 27/09/2022] Trial Registered Prospectively |
Last Modified On: |
23/09/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Single Arm Study |
Public Title of Study
|
EFFECTIVENESS OF SHORT-DURATION ABDOMINAL MUSCLE STRENGTHENING PROGRAM IN IMPROVEMENT OF FUNCTIONAL MOVEMENT SCORE IN MINIMALLY ACTIVE STUDENTS |
Scientific Title of Study
|
EFFECTIVENESS OF SHORT-TERM CORE STRENGTHENING PROGRAM IN IMPROVEMENT OF FUNCTIONAL MOVEMENT SCORE IN MINIMALLY ACTIVE STUDENTS |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
ANUPRIYA P |
Designation |
POST- GRADUATE STUDENT |
Affiliation |
LAXMI MEMORIAL COLLEGE OF PHYSIOTHERAPY |
Address |
1st FLOOR,A.J TOWER,BALMATTA,MANGALORE DAKSHINA KANNADA A.J TOWER, BALMATTA, MANGALORE
DAKSHINA KANNADA Dakshina Kannada KARNATAKA 575002 India |
Phone |
9035224668 |
Fax |
|
Email |
panupriya64@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Priya S |
Designation |
Associate Professor |
Affiliation |
LAXMI MEMORIAL COLLEGE OF PHYSIOTHERAPY |
Address |
A.J TOWERS, BALMATTA, MANGALORE DAKSHINA KANNADA
Dakshina Kannada KARNATAKA 575002 India |
Phone |
9449729147 |
Fax |
|
Email |
priya.sv1@gmail.com |
|
Details of Contact Person Public Query
|
Name |
ANUPRIYA P |
Designation |
POST- GRADUATE STUDENT |
Affiliation |
LAXMI MEMORIAL COLLEGE OF PHYSIOTHERAPY |
Address |
1st FLOOR, A.J TOWER,BALMATTA,MANGALORE DAKSHINA KANNADA A.J TOWER, BALMATTA, MANGALORE
DAKSHINA KANNADA Dakshina Kannada KARNATAKA 575002 India |
Phone |
9035224668 |
Fax |
|
Email |
panupriya64@gmail.com |
|
Source of Monetary or Material Support
|
Laxmi memorial college of physiotherapy |
|
Primary Sponsor
|
Name |
LAXMI MEMEORIAL COLLEGE OF PHYSIOTHERAPY |
Address |
LAXMI MEMEORIAL COLLEGE OF PHYSIOTHERAPY, A.J TOWER, BALMATTA, MANGALORE |
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 |
ANUPRIYA P |
LAXMI MEMORIAL COLLEGE OF PHYSIOTHERAPY. |
FIRST FLOOR A J TOWERS BALMATTA MANAGALURU 575002 Dakshina Kannada KARANATAKA Dakshina Kannada KARNATAKA |
9035224668
panupriya64@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee A J Institute of Medical Sciences and Research Center |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
ICD-10-CM Codes M00-M99: Diseases of the musculoskeletal system and connective tissue ICD-10-CM Codes |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
Intervention |
SHORT- TERM CORE STRENGTHENING PROGRAM |
Participants were required to take part in a two-week core strengthening program which included supervised sessions three times per week with sessions lasting 30 minutes. Core strengthening program involved an isometric exercise program, and was implemented in the first and second week.
The treatment included exercises for increasing the mobility and strength of the neck, shoulders, pelvis and hips. In the first two weeks, participants had to perform various durability exercises which includes: all position planks (pushup, forearm, side, reverse), plank walk, plank jacks, forearm to pushup plank, feet elevated side plank, 3- point plank, bird dog. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
28.00 Year(s) |
Gender |
Both |
Details |
Student fulfilling the IPAQ criteria where individuals meeting at least one of the three criteria that is 3 or more days of vigorous activity of at least 20 minutes per day OR 5 or more days of moderate- intensity activity or walking of at least 30 minutes per day OR 5 or more days of any combination of walking, moderate- intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/ week, healthy subjects who were not engaged in any systematic training in the last two years, participants were free of any musculoskeletal injury or illness.
|
|
ExclusionCriteria |
Details |
Participated in any systematic training in last 2 years, participants who had musculoskeletal related injury, recent surgical intervention that limited the participation due to physician- imposed restriction.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
FUNCTIONAL MOVEMENT SCREEN |
Pre- functional movement score (baseline)
Post- functional movement score (after three weeks of short- term core strengthening program) |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="41" Sample Size from India="41"
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 2 |
Date of First Enrollment (India)
|
30/09/2022 |
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="2" 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
|
Ethical clearance has been obtained from institutional ethical committee. Subjects fulfilling the inclusion criteria had enrolled for the study. A brief introduction about the study procedure will be explained to all subjects. Participants will be recruited on basis of the inclusion and exclusion criteria and an initial examination including demographic data will be carried out. For this study, minimally active is defined as individuals meeting at least one of the three criterias that is 3 or more days of vigorous activity of at least 20 minutes per day or 5 or more days of moderate- intensity activity or walking of at least 30 minutes per day or 5 or more days of any combination of walking, moderate- intensity or vigorous intensity activities achieving a minimum of at least 600 MET- min/ week would be defined as achieving the minimum recommended to be considered ’minimally active’. The FMS scores were examined before and after a two- week training intervention. The intervention consisted of the implementation of a core exercise program for 30 minutes ( three times per week, 20-30 repetitions and average hold of 50s). |