CTRI Number |
CTRI/2022/07/044196 [Registered on: 21/07/2022] Trial Registered Prospectively |
Last Modified On: |
14/12/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) Other (Specify) [Active and Resisted Exercise ] |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Type of Strength training in Short-put athletes in enhancing performance |
Scientific Title of Study
|
Effect of Lower body, Core and Upper body kinematic chain exercise protocol on throwing performance in College shotput athletes “a Pilot study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vinod Kumar K C |
Designation |
Associate Professor |
Affiliation |
College of Physiotherapy, DSU |
Address |
Shavige Malleshwara Hills, 91st Main Rd, 1st Stage, Kumaraswamy Layout, Bengaluru, Karnataka 560078 Shavige Malleshwara Hills, 91st Main Rd, 1st Stage, Kumaraswamy Layout, Bengaluru, Karnataka 560078 Bangalore KARNATAKA 5620078 India |
Phone |
9036200878 |
Fax |
|
Email |
vinod-mpt@dsu.edu.in |
|
Details of Contact Person Scientific Query
|
Name |
Vinod Kumar K C |
Designation |
Associate Professor |
Affiliation |
College of Physiotherapy, DSU |
Address |
Shavige Malleshwara Hills, 91st Main Rd, 1st Stage, Kumaraswamy Layout, Bengaluru, Karnataka 560078 Shavige Malleshwara Hills, 91st Main Rd, 1st Stage, Kumaraswamy Layout, Bengaluru, Karnataka 560078
KARNATAKA 5620078 India |
Phone |
9036200878 |
Fax |
|
Email |
vinod-mpt@dsu.edu.in |
|
Details of Contact Person Public Query
|
Name |
Vinod Kumar K C |
Designation |
Associate Professor |
Affiliation |
College of Physiotherapy, DSU |
Address |
Shavige Malleshwara Hills, 91st Main Rd, 1st Stage, Kumaraswamy Layout, Bengaluru, Karnataka 560078 Shavige Malleshwara Hills, 91st Main Rd, 1st Stage, Kumaraswamy Layout, Bengaluru, Karnataka 560078
KARNATAKA 5620078 India |
Phone |
9036200878 |
Fax |
|
Email |
vinod-mpt@dsu.edu.in |
|
Source of Monetary or Material Support
|
college of Physiotherapy, school of health sciences , Dayananda sagar university, Shavige Malleshwara Hills, 1st Stage, Kumaraswamy Layout, Bengaluru, Karnataka 560078 |
|
Primary Sponsor
|
Name |
No |
Address |
No |
Type of Sponsor |
Other [] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Vinod Kumar KC |
College of Physiotherapy |
Shavige Malleshwara Hills, 91st Main Rd, 1st Stage, Kumaraswamy Layout, Bengaluru, Karnataka 560078 Bangalore KARNATAKA |
9036200878 08042161716 vinod-mpt@dsu.edu.in |
Dr Srihari Sharma |
Physiotherapy out patient department |
college of physiotherapy , building no 12, Shavige Malleshwara Hills, 91st Main Rd, 1st Stage, Kumaraswamy Layout, Bengaluru, Karnataka 560078 Bangalore KARNATAKA |
9886040520
srihari-physio@dsu.edu.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
College of Physiotherapy, DSu |
Approved |
College of Physiotherapy, DSu |
Submittted/Under Review |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
SHOT PUT ATHLETS |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
conventional exercises |
conventional exercise Protocol
exercises will be performed 6 days a week for 8 weeks (Sunday rest day)
1. warmup exercises - 5 min
2. Ten thrower exercises - 10min
3. core stability exercises 10 min
4. shoulder PNF exercises
5 min
4. cooldown period 5 min
Total exercise session for 1 hour which includes rest period in between exercises |
Intervention |
Lower body, Core and Upper body kinematic chain exercise protocol |
Kinetic chain exercise Protocol
exercises will be performed thrice a week for 8 weeks(Sunday rest day)
1. warmup exercises - 5 min
2. Ten thrower exercises - 10min
3. core stability exercises 10 min
3. shoulder PNF exercises 5 min
4. kinematic chain exercise - 15 min
5. cooldown period 5 min
Total exercise session for 1 hour which includes rest period in between exercises |
|
Inclusion Criteria
|
Age From |
19.00 Year(s) |
Age To |
24.00 Year(s) |
Gender |
Both |
Details |
Healthy shotput athlete’s – 2021 PAR-Q+ pre participation evaluation questioner score of zero.(9)
Athletes with SPADI scale score of 0%.(10)
Male and female shot-put athletes.
Athletes aged between 19 and 24 yrs.
Athletes with basic English knowledge.
Athletes in and around Bangalore.
Athletes willing to participate in the study, sign the consent form and strictly following the exercise protocol.
|
|
ExclusionCriteria |
Details |
History of recent upper limb trauma: shoulder trauma or current shoulder pathology (traumatic injury, glenohumeral joint dislocation, acromioclavicular joint separation, a history of shoulder, waist and chest surgery, fracture or dislocation of the affected shoulder, inflammatory joint disease, fibromyalgia) elbow injuries, wrist and hand injuries (16)
History of recent lower limb trauma: hip trauma or current hip, knee & ankle pathology, a history of hip, knee and ankle, surgery,
History of recent spinal trauma: cervical, thoracic & lumbar trauma or current pathology (cervical spondylosis, lumbar spondylosis, IVDP etc) (16)
Sever musculoskeletal disease like osteoarthritis restraining the patient to perform.
History of pulmonary disease like COPD.
Uncontrolled arrhythmia.
Sever musculoskeletal disease like osteoarthritis restraining the patient to perform
Hypertension (a systolic blood pressure of >160 mm Hg or a diastolic blood
pressure of >100 mm Hg). .
Patients with hematologic, renal, or hepatic dysfunction. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Shotput throwing distance
Preferred throwing style |
o week(pre intervention)
8th week(post intervention)
12th week(follow up) |
|
Secondary Outcome
|
Outcome |
TimePoints |
Shotput throwing distance |
4th week |
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
25/07/2022 |
Date of Study Completion (India) |
14/12/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
01/12/2022 |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Preparatory stage |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The participants who fills the inclusion criteria and give consent to participate in the study will be assigned to exercise protocol kinematic chain exercise protocol for 8 weeks Exercise Protocol includes warm up exercises kinetic chain exercises cool down exercises
outcome measures 1. shotput throwing distance 2. preferred throwing style will be assessed and statistical analysis will be done to find out the effect of the intervention |