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临床试验/NCT07335926
NCT07335926已完成不适用

Tele-Pilates for Primary Dysmenorrhea: A Randomized Controlled Trial on Pain, Symptoms, and Trunk Endurance

Atlas University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Menstrual pain severity

研究概览

简要总结

This randomized controlled trial investigates the effectiveness of a synchronized tele-Pilates program on menstrual pain, symptom severity, physical disability, and trunk muscle endurance in women with primary dysmenorrhea (PD). The intervention includes 16 supervised online Pilates sessions delivered over eight weeks.

详细描述

Primary dysmenorrhea is a prevalent gynecological condition characterized by painful menstruation. Exercise, particularly core stabilization and mind-body methods like Pilates, may improve both physical and psychological symptoms associated with PD. In this single-center RCT, 34 women aged 18-35 with PD were randomized to either a Tele-Pilates group or a control group. The Pilates group received supervised online sessions twice weekly for 8 weeks. Outcomes included pain severity (VAS), symptom burden (MSQ), functional impairment (FEMD), disability (Oswestry LBP Index), and trunk muscle endurance (McGill tests). Findings demonstrated significant improvements in the Pilates group across all domains.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Women aged 18-35 years
  • Regular menstrual cycles (28±7 days)
  • VAS ≥5 for menstrual pain
  • Diagnosed with primary dysmenorrhea

排除标准

  • Secondary dysmenorrhea (e.g., endometriosis, fibroids)
  • Pregnancy or use of intrauterine devices
  • Significant comorbidities (e.g., spondylolisthesis)

研究组 & 干预措施

Tele-Pilates Group

Experimental

Participants received 16 synchronous tele-Pilates sessions over 8 weeks (twice per week). Exercises followed the APPI method including stretching, core strengthening, pelvic floor training, and breathing-focused control.

干预措施: standardized menstrual health education online (Behavioral)

Tele-Pilates Group

Experimental

Participants received 16 synchronous tele-Pilates sessions over 8 weeks (twice per week). Exercises followed the APPI method including stretching, core strengthening, pelvic floor training, and breathing-focused control.

干预措施: Tele-Pilates Exercise program (Other)

Control Group

Active Comparator

Participants received standardized menstrual health education online but no exercise intervention.

干预措施: standardized menstrual health education online (Behavioral)

结局指标

主要结局

Menstrual pain severity

时间窗: Change from baseline to post-intervention (8 weeks)

Menstrual pain severity was assessed using a 10 cm Visual Analog Scale, where participants marked the most intense pain experienced during their last menstrual cycle.

次要结局

  • Trunk muscle endurance (McGill tests: flexor muscles)(Change from baseline to post-intervention (8 weeks))
  • Menstrual symptom severity (Menstrual Symptom Questionnaire total score)(Change from baseline to post-intervention (8 weeks))
  • Disability due to low back pain (Oswestry Index)(Change from baseline to post-intervention (8 weeks))
  • Functional and emotional burden (Functional and Emotional Measure of Dysmenorrhea total score)(Change from baseline to post-intervention (8 weeks))
  • Trunk muscle endurance (McGill tests: extensor muscles)(Change from baseline to post-intervention (8 weeks))
  • Trunk muscle endurance (McGill tests: lateral flexor muscles)(Change from baseline to post-intervention (8 weeks))

研究者

发起方
Atlas University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilal Denizoğlu Külli

Assoc. Prof.

Atlas University

研究点 (1)

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