| CTRI Number |
CTRI/2024/10/074552 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of trunk rotation training on movement and power generation in athletes |
|
Scientific Title of Study
|
Effect of kinetic chain training on movement quality and power in recreational overhead athletes: A pragmatic randomized controlled 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 |
Srinivas M |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Exercise and Sport Sciences, Manipal College of
Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7026246050 |
| Fax |
|
| Email |
srinivasbhoopalam7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prabu Raja G |
| Designation |
Assistant Professor – Selection grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Exercise and Sport Sciences, Manipal College of
Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8867591333 |
| Fax |
|
| Email |
prabu.raja@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prabu Raja G |
| Designation |
Assistant Professor – Selection grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Exercise and Sport Sciences, Manipal College of
Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8867591333 |
| Fax |
|
| Email |
prabu.raja@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Exercise and Sport Sciences, Manipal College of Health Professions, MAHE, Manipal, Udupi, Karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Srinivas M |
| Address |
Department of Exercise and Sport Sciences, Manipal College of Health Professions, MAHE, Manipal, Udupi, Karnataka, India - 576104 |
| 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 |
| Prabu Raja G |
Marena Sports Complex, MAHE |
Marena Rd, Madhav Nagar, Eshwar Nagar, MAHE, Manipal - 576104
Udupi
KARNATAKA |
8867591333
prabu.raja@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Recreational Overhead Athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
In the control group, the
participants will not be provided with the interventional plan (Kinetic Chain Training) and they
will be allowed to continue with their type of training or no training if the participant does not train. |
| Intervention |
Kinetic Chain Training |
Consists of 6 different exercises (Dead bugs, Plank with rotation, Side Plank with rotation, Pall of press, Chop and lift, and Landmine rotation). The intervention is for 4 weeks long, with 3 sessions each week – a total of 12 supervised sessions.
Each session will be individualized based on the participants training status and will be about 30 – 40 minutes long.
Initially, exercises will be performed for 1-2 sets and then increased to 3-4 sets during the final two weeks. Each set consists of 8-10 repetitions. The progression will be based on the individual’s rate of perceived exertion (RPE) during individual sessions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Recreational overhead athletes who have played the sport at least 2-4 hours/week for the last 6 months. |
|
| ExclusionCriteria |
| Details |
History of musculoskeletal injuries in the past 6 months.
History of upper and lower extremities or spinal surgery in the past 1 year.
History of cardiovascular or respiratory diseases. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Movement quality |
Pre and Post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Power.
Shoulder rotational range of motion.
Myofascial stiffness of the shoulder complex muscles (Sternocleidomastoid, Deltoid, Trapezius, Supraspinatus, Infraspinatus, Rhomboids, and Pectoralis major). |
Pre and Post |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Studies have shown improvement in muscle recruitment patterns when incorporating the kinetic chain. However, there has been no intervention to understand the effect of kinetic chain training on movement quality, power, range of motion, and myofascial stiffness.
It is a pragmatic randomized controlled trial with a duration of 6 months. Healthy participants are selected under certain and after getting their consent study will be conducted. Participants in the intervention group will come for a total of 12 supervised sessions in a span of 4 weeks. The control group will continue with their own training or no training if they don’t train.
Pre and post-intervention data is collected for movement quality, power, rotational range of motion, and myofascial stiffness. |