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临床试验/NCT06302166
NCT06302166招募中不适用

Effects of High Intensity Circuit Training and Intermittent Fasting on Polycystic Ovarian Syndrome

Riphah International University2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
33
试验地点
2
主要终点
PCOS Morphology

研究概览

简要总结

The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.

Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Unmarried females
  • •Diagnosed with PCOS Phenotype A based on Rotterdam Criteria:
  • •PCOM on US
  • •Ovulatory dysfunction
  • •Clinical Hyperandrogenism (Hirsutism modified Ferriman Gallway score ≥ 8)
  • •Not engaged in any regular lifestyle intervention for <3 Months prior to inclusion

排除标准

  • •Use of Estrogen, Progestin or combination.
  • •Taking medications or supplements for Insulin resistance < 3 months prior to the inclusion
  • •Type I or II DM
  • •Hypo/hyperthyroidism
  • •BMI ≥27 (Obese according to BMI Asia)

研究组 & 干预措施

High Intensity circuit training (HICT)

Active Comparator

For the group allocated with exercise, high intensity circuit training (HICT) of three supervised sessions per week for 20-30 mins will be given. HICT commenced after 10 mins low to moderate intensity warm up and after completing session ended with 10 mins cool down. Intensity of exercise will be measured on borg rating of perceived exertion (RPE). Perceived exertion is how hard you feel like your body is working. Although this is a subjective measure your exertion rating based on a 0 to 10 modified borg rating scale may provide a fairly good estimate of your actual heart rate during physical activity. 0 perceiving "no exertion at all" to 10 perceiving a "maximal exertion" of effort. A moderate intensity activity will be at 3-5 perceiving "somewhat hard", similarly 6-10 will be perceived as high intensity activity.

干预措施: High Intensity Circuit training (HICT) (Other)

Intermittent fasting (IF)

Active Comparator

For the group allocated with intermittent fasting, a time restricted feeding (TRF) methodology will be administered. The Fasting protocol will begin with a 12-hour eating window (12:12) and will gradually go down to 8 hours eating window over a period of 8 weeks (16:8).

干预措施: Intermittent Fasting (IF) (Other)

Combination of HICT and IF

Active Comparator

The group allocated with both exercise and intermittent fasting will be provided with both HICT for three sessions per week and 8 hours' time restricted eating.

干预措施: Combination of HICT and IF (Other)

结局指标

主要结局

PCOS Morphology

时间窗: 8th Week

Changes from baseline PCOS morphology on the ultrasound will be done by calculating the number of follicles and measuring follicle size. For this purpose, ultrasound imaging is the best option as it is both harmless and inexpensive. PCOS is considered if on ultrasound imaging there are 12 or more than 12 follicles in the ovary and has size of 2-9 mm or volume of 10 cm 3 .

次要结局

  • Anthropometrics(8th Week)
  • Clinical Hyperandrogenism(8th Week)
  • Body Image concerns(8th Week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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