| CTRI Number |
CTRI/2026/03/105540 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study To Check The Influence Of Aerobic Training And Breathing Exercises On Risk Factors Of Female Athlete Triad And Hyperventilation Syndrome In Female Athletes |
|
Scientific Title of Study
|
Influence Of Aerobic Training And Breathing Exercises On Risk Factors Of Female Athlete Triad And Hyperventilation Syndrome In Female Athletes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/KCA/PT/2025/22 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sukhamrit Singh |
| Designation |
student MPT(cardiopulmonary) |
| Affiliation |
Khalsa College, Amritsar |
| Address |
Department of physiotherapy, Khalsa College, Amritsar, Punjab
village bhaini lidhran, vpo majitha, amritsar, punjab,143601
Amritsar
PUNJAB
143002
India |
| Phone |
09781394021 |
| Fax |
|
| Email |
singhsukhamrit88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu Vishist |
| Designation |
Assistant Professor |
| Affiliation |
Khalsa College, Amritsar |
| Address |
Department of physiotherapy, Khalsa College, Amritsar, Punjab
Amritsar
PUNJAB
143002
India |
| Phone |
7837089602 |
| Fax |
|
| Email |
manuvishist26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sukhamrit Singh |
| Designation |
student MPT(cardiopulmonary) |
| Affiliation |
Khalsa College, Amritsar |
| Address |
Department of physiotherapy, Khalsa College, Amritsar, Punjab
village bhaini lidhran, vpo majitha, amritsar, punjab,143601
Amritsar
PUNJAB
143002
India |
| Phone |
09781394021 |
| Fax |
|
| Email |
singhsukhamrit88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Khalsa College, Amritsar, Punjab, 143002. |
|
|
Primary Sponsor
|
| Name |
Sukhamrit Singh |
| Address |
village Bhaini Lidhran, VPO Majitha, Amritsar, Punjab, 143601 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Manu vishist |
Department of physiotherapy, Khalsa College, Amritsar, Punjab |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sukhamrit Singh |
Khalsa College |
Department of physiotherapy, Khalsa College, Amritsar, Punjab
Amritsar
PUNJAB |
09781394021
singhsukhamrit88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Khalsa college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female Athletes with Hyperventilation Syndrome and Female Athlete Triad |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Breathing exercises with usual regular training |
participants recieve breathing exercises along with their regular daily training for 6 weeks |
| Comparator Agent |
Fartlek training group |
Participants only recieve fartlek training for 3 days a week for 6 weeks |
| Intervention |
Fartlek training with breathing exercises (diaphragmatic and pursed lip breathing) |
participants recieve fartlek training and breathing exercises for 3 alternate days in a week and total duration is 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Female Athletes having positive scores for Nijmegen questionnaire and LEAF-Q questionnaire |
|
| ExclusionCriteria |
| Details |
•Current use of supplements for influencing bone density.
•History 0f major musculoskeletal injury in 6 months
•Current use of any hormonal therapy.
•Females on current use of medications for psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nijmegen Questionnaire |
scores less than 23 are to be targetd |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| LEAF-Q questionnaire |
sccores less than 8 are to be targeted |
| resting heart rate |
a lower heart compared to the pre intrevention heart rate |
| recovery heart rate |
to check how optimally heart rate is recoverd as compared to pre intervention |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
16/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Female athletes are more at risk of menstrual dysfunction and hyperventilation due to stress and performance pressure. This leads to low bone density and disturbed cardiopulmonary parameters. Moreover, there is less evidence on the effects of breathing exercises and aerobic training on female athletes who have hyperventilation syndrome and are at the risk of the female athlete triad. This study will help to establish the effect of breathing and aerobic training on improving quality of life. The study will have an impact on reducing the risk factors of the female athlete triad and the hyperventilation experienced by female athletes. Hypothesis: Null hypothesis · There will be no effectiveness of breathing exercises and aerobic training on hyperventilation syndrome in female athletes with the female athlete triad. · There will be no effectiveness of breathing exercises and aerobic training on risk factors of the female athlete triad. · There will be no significant difference between pre- and post-measurements of resting and recovery heart rate. Alternate hypothesis · There will be significant effectiveness of breathing exercises and aerobic training on hyperventilation syndrome in female athletes with the female athlete triad. · There will be significant effectiveness of breathing exercises and aerobic training on risk factors of the female athlete triad. There will be a significant difference between resting and recovery heart rate. · There will be a significant difference between pre- and post-measurements of resting and recovery heart rate. |