| CTRI Number |
CTRI/2025/02/080083 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
The Impact of Different Body Rhythms on Endurance Athletes’ Performance |
|
Scientific Title of Study
|
Effect Of Different Chronotypes On Physical, Physiological, And Cognitive Performance In Endurance Athletes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hetal Bhoir |
| Designation |
post-graduate student |
| Affiliation |
SGT University Faculty of physiotherapy |
| Address |
Department of physiotherapy, Faculty of physiotherapy, SGT University, Gurgaon
Gurgaon
HARYANA
122006
India |
| Phone |
9819223125 |
| Fax |
|
| Email |
hetalbhoir1506@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pooja Bhati |
| Designation |
Assistant Professor |
| Affiliation |
SGT University Faculty of physiotherapy |
| Address |
Department of physiotherapy, faculty of physiotherapySGT University, Gurgaon
Gurgaon
HARYANA
122505
India |
| Phone |
8802192456 |
| Fax |
|
| Email |
pooja.bhati092@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Anand |
| Designation |
Dean and professor |
| Affiliation |
SGT University Faculty of physiotherapy |
| Address |
Department of physiotherapy,faculty of physiotherapy,SGT University, Gurgaon
Gurgaon
HARYANA
122505
India |
| Phone |
9810240409 |
| Fax |
|
| Email |
pooja.physiotherapy@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| Faculty of physiotherapy, SGT University, Gurgaon, Haryana-122505 |
|
|
Primary Sponsor
|
| Name |
Hetal Bhoir |
| Address |
905, B tower, ROF Aalayas sector 102, Dhankot, Gurgaon, Haryana 122006 |
| 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 |
| Hetal Bhoir |
SGT University |
Department of physiotherapy, faculty of physiotherapy, SGT University
Gurgaon
HARYANA |
9819223125
hetalbhoir1506@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Faculty of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy humans |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
evening chronotype |
performance testing of the endurance athletes in physical, physiological and cognitive parameters |
| Intervention |
morning chronotype |
performance testing of the endurance athletes in physical, physiological and cognitive parameters |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Male and female athletes with minimum 2 years of competitive experience in endurance sports (Cycling, Running, Swimming, Triathlon, Volleyball, Football) |
|
| ExclusionCriteria |
| Details |
Subjects with any current musculoskeletal or neurological disorders.
Any injuries such as fractures, sprains, strains, etc. in the past 6 months.
Subjects with any cognitive impairments or conditions.
Subjects have a history of or current symptoms of cardiovascular illness (such as angina, shortness of breath, or uncontrolled hypertension.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To investigate the differences in physical, physiological, and cognitive parameters among different chronotypes of endurance athletes.
|
baseline and after a washout period of 48hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To examine the physical (Yo-Yo intermittent recovery test, VO2max, Body Composition Impedance), physiological (HRV, HRR, sleep satisfaction, & cognitive (Stroop color & word test, ACSI) parameters among different chronotypes during morning & evening time. |
at baseline & after a washout period of 48 hrs |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
17/02/2025 |
| 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="1"
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
|
Before starting the procedure, each participant fills out the consent form. After filling out the consent form the participants will be assigned to different groups (M-types and E-types) through a convenient sampling method. The therapist will collect pre-assessment demographic data. After the evaluation is over for the respected outcome measures (physical (Yo-Yo intermittent recovery test, VO2max, Body Composition Impedance), physiological (HRV, HRR, sleep satisfaction, and cognitive (Stroop color & word test, ACSI), data will be collected from all the participants to check for a significant improvement in the outcome measures. |