| CTRI Number |
CTRI/2025/08/093933 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of aerobic and anaerobic exercises on female athletes with female athlete triad |
|
Scientific Title of Study
|
Impact of aerobic and anaerobic training protocol on cardiopulmonary parameters and health-related outcomes among collegiate female athletes with female athlete triad |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manu Vishist |
| Designation |
Research Scholar |
| Affiliation |
Lovely Professional University |
| Address |
Lovely School of Physiotherapy,
Lovely Professional University, Phagwara, Jalandhar, Punjab, India.
Jalandhar
PUNJAB
144411
India |
| Phone |
7837089602 |
| Fax |
|
| Email |
manuvishist26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Zaki Anwer |
| Designation |
Supervisor |
| Affiliation |
Lovely Professional University |
| Address |
Lovely School of Physiotherapy, Lovely Professional University, Jalandhar, Punjab, India
Jalandhar
PUNJAB
144411
India |
| Phone |
9816285755 |
| Fax |
|
| Email |
zakianwer.1974@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manu Vishist |
| Designation |
Research Scholar |
| Affiliation |
Lovely Professional University |
| Address |
Lovely School of Physiotherapy,
Lovely Professional University, Phagwara, Jalandhar, Punjab, India.
Jalandhar
PUNJAB
144411
India |
| Phone |
7837089602 |
| Fax |
|
| Email |
manuvishist26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Khalsa College Amritsar, Punjab, India, 143001 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 |
| Varinder Kaur |
Khalsa College |
Department of Physiotherapy,
Room no. PT LAB-1
Amritsar
PUNJAB |
8437243887
varinderkaur4187@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E288||Other ovarian dysfunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic Exercise Training |
Aerobic exercise on treadmill
Warm-up Phase: 5-minute warm-up on the treadmill at a low load
Exercise Phase: Participants will be instructed to run on treadmill without inclination at set Frequency, intensity, time, type.
Cool down Phase: 5-minute recovery and relaxation phase
|
| Intervention |
Anaerobic exercise training |
Anaerobic exercise on treadmill
Warm-up Phase: 5-minute warm-up on the treadmill at a low load
Exercise Phase: Participants will be instructed to run on treadmill with initial inclination of 10% at target heart rate for 5 minute followed by rest for 2 minutes. This will be repeated 4 times during per session with 2% increase in inclination each time.
Cool down Phase: 5-minute recovery and relaxation phase
|
| Comparator Agent |
Control group |
Stretching and flexibility exercises:
Warm-up Phase: 5-minute warm-up by brisk walking.
Exercise Phase: Participants will be instructed to do stretches targeting different muscle groups like hamstring stretches, quadriceps stretches, calf stretches and shoulder stretches. This will involve holding a stretch in a comfortable position for each muscle group for 60 seconds.
Cool down Phase: 5-minute recovery phase
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Collegiate female athletes actively involved in sports like football, cricket, volleyball, basketball, Road cycling, hockey, Kabaddi for past 2 years
Female athletes with female athlete triad
|
|
| ExclusionCriteria |
| Details |
Subjects unwilling to participate in the study
Subjects with a history of menstrual, dietary, and musculoskeletal abnormalities due to causes other than their participation in athletics
Females who have undergone any hormone replacement therapy
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Cardiopulmonary parameters
• Blood pressure
• Resting heart rate
• Maximal heart rate
• VO2 max
• SpO2
• FVC
• FEV1
• Maximum inspiratory mouth pressure
• Maximum expiratory mouth pressure
|
1. Baseline
2. Eighth week
3. Fifteenth week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Health related outcomes with SF-36 Questionnaire |
1. Baseline
2. Eighth week
3. Fifteenth week
|
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="1"
Months="5"
Days="30" |
|
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
|
Female athletes who will meet with inclusion and exclusion
criteria will be randomly divided into three groups (Group-A, Group-B and
Group-C) using a simple randomization process that includes the lottery method.
Before the commencement of the procedure, the
purpose of the study will be explained to the subjects through patient
information sheet and written informed consent will be obtained from the
subjects. |