跳至主要内容
临床试验/CTRI/2025/08/093933
CTRI/2025/08/093933尚未招募2 期

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

未提供1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
81
试验地点
1
主要终点
1 Cardiopulmonary parameters

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
Female

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

1 Cardiopulmonary parameters

时间窗: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• Blood pressure

时间窗: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• Resting heart rate

时间窗: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• Maximal heart rate

时间窗: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• VO2 max

时间窗: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• SpO2

时间窗: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• FVC

时间窗: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• FEV1

时间窗: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• Maximum inspiratory mouth pressure

时间窗: 1. Baseline | 2. Eighth week | 3. Fifteenth week

• Maximum expiratory mouth pressure

时间窗: 1. Baseline | 2. Eighth week | 3. Fifteenth week

次要结局

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

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Manu Vishist

Lovely Professional University

研究点 (1)

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