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Clinical Trials/CTRI/2025/08/093933
CTRI/2025/08/093933Not yet recruitingPhase 2

Impact of aerobic and anaerobic training protocol on cardiopulmonary parameters and health-related outcomes among collegiate female athletes with female athlete triad

Not provided1 site in 1 country81 target enrollmentStarted: September 15, 2025Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
81
Locations
1
Primary Endpoint
1 Cardiopulmonary parameters

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 25.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

1 Cardiopulmonary parameters

Time Frame: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• Blood pressure

Time Frame: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• Resting heart rate

Time Frame: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• Maximal heart rate

Time Frame: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• VO2 max

Time Frame: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• SpO2

Time Frame: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• FVC

Time Frame: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• FEV1

Time Frame: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• Maximum inspiratory mouth pressure

Time Frame: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• Maximum expiratory mouth pressure

Time Frame: 1. Baseline | 2. Eighth week | 3. Fifteenth week

Secondary Outcomes

  • Health related outcomes with SF-36 Questionnaire(1. Baseline)

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

Manu Vishist

Lovely Professional University

Study Sites (1)

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