| CTRI Number |
CTRI/2024/07/069747 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Cold Douche On Physical Exhaustion in Athletes |
|
Scientific Title of Study
|
Impact Of Cold Douche to Lower Extremities On Neuromuscular Fatigue in Athletes-A Randomized Control 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 |
Dr Kotresh Hiremath R |
| Designation |
PG student |
| Affiliation |
SDM College Of Naturopathy and Yogic Sciences |
| Address |
Department of Natural Therapeutics,
SDM College Of Naturopathy and Yogic Sciences, Ujire, Belthangadi,
Dakshina Kannada-574240
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8277466588 |
| Fax |
|
| Email |
kotreshhm97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kotresh Hiremath R |
| Designation |
PG student |
| Affiliation |
SDM College Of Naturopathy and Yogic Sciences |
| Address |
Department of Natural Therapeutics,
SDM College Of Naturopathy and Yogic Sciences, Ujire, Belthangadi,
Dakshina Kannada-574240
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8277466588 |
| Fax |
|
| Email |
kotreshhm97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha B Shetty |
| Designation |
Dean Division of Nutrition and Dietetics Department |
| Affiliation |
SDM College Of Naturopathy and Yogic Sciences |
| Address |
Department of Nutrition and Dietetics,
SDM College Of Naturopathy and Yogic Sciences, Ujire, Belthangadi,
Dakshina Kannada-574240
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9449714767 |
| Fax |
|
| Email |
gbsujire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital Shantivana, Dharmasthala, Belthangadi,
Dakshina Kannada-574216
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Dr Kotresh Hiremath R |
| Address |
SDM College Of Naturopathy and Yogic Sciences, Ujire, Belthangadi,
Dakshina Kannada-574240 |
| 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 Kotresh Hiremath R |
Shri Dharmasthala Manjunatheshwara Yoga and Nature cure Hospital Shanthivana |
COE,Department of Natural Theuraputics,Shanthivana,
Dharmasthala,Belathangadi,
Dakshina Kannada-574216
Karnataka
India
Dakshina Kannada
KARNATAKA |
8277466588
kotreshhm97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Activity followed by Cold Douche to lower extremities |
Subjects will be asked to undergo treadmill running this is followed by cold douche to lower extremities. The intervener stands holding the nozzle of the apparatus at a distance of 3.5 meters away from the subject and directs the single column of cold water of temperature 18°C to 24℃ with pressure of 40lbs towards both the lower extremities covering all the muscles of lower limb
Duration- 5 minutes |
| Comparator Agent |
Supine rest |
Subjects will be asked to undergo treadmill running this is followed by supine rest. Subjects are asked to relax for a
Duration of 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: 16 – 25 years
2.Subjects who are willing to participate in the study
3.Gender: Male and Female
4.Athletes
|
|
| ExclusionCriteria |
| Details |
1.Open wounds
2.Subjects not willing to participate in the study
3.Chronic Fatigue Syndrome (CFS)
4.Medical illness with medications
5.Smokers
6.Recent injuries and neuromuscular disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Electromyographic variables
1 Root Mean Square(RMS) and
2 Integral of EMG |
Baseline ,5 minutes post-intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To quantify the changes in Maximum Voluntary Contraction (MVC) |
Bseline , 5 minutes post-intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
30/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/03/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
Modification(s)
|
Previous studies on cold applications have demonstrated the extensive beneficial effect of cold water as a recovery strategy to overcome the acute neuromuscular fatigue and prevent sports injuries, thus improving the performance of the athletes in further competitions. Hence this study is designed to see the effect of cold douche on improving neuromuscular fatigue and muscle activity in the most active lower extremity muscles among the athletes |