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临床试验/CTRI/2024/07/071186
CTRI/2024/07/071186已完成不适用

Efficacy of Upper Trunk Proprioceptive Neuromuscular Facilitation in comparison with Complex Decongestive Therapy in post mastectomy patients

Epshita kakati1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月29日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Universal Goniometer

研究概览

简要总结

NEED OF THE STUDY: Despite advancements in surgical techniques, many breast cancer survivors continue to face physical and emotional challenges. In India, where breast cancer rates are high, there is a critical lack of clinical data on therapies like Proprioceptive Neuromuscular Facilitation (PNF) and Complex Decongestive Therapy (CDT), necessitating research to establish standardized approaches for improving arm function, aerobic capacity, quality of life, and psychological well-being.

SIGNIFICANCE OF THE STUDY: This study aims to address the needs of women undergoing mastectomy for breast cancer by evaluating the effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) stretching and Complex Decongestive Therapy (CDT). These therapies have the potential to improve flexibility, muscle function, and lymphatic activity, thereby reducing lymphedema, enhancing upper extremity and respiratory function, and improving overall quality of life. By filling gaps in existing research, this study not only advances clinical practices but also informs healthcare professionals and educates the community, leading to more comprehensive and effective societal support for women undergoing mastectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 64.00 Year(s)(—)
性别
Female

入选标准

  • Females with unilateral mastectomy for stage I and II breast cancer.
  • Females who have undergone mastectomy 1-3 years prior.
  • Females who have finished treatment i.e chemotherapy, radiotherapy
  • Females diagnosed with breast cancer-associated lymphedema.
  • Female who has undergone breast cancer surgery and experiencing discomfort at the surgical site, swelling in the afflicted limb, and heaviness in the affected limb.
  • Female who has experienced lymphedema with an increase of more than 3 cm compared to the opposite extremity.
  • Ability to walk without assistance at least 100 meters and no contraindications for participating in aerobic exercises.

排除标准

  • Females diagnosed with metastatic breast cancer.
  • Female anticipating breast reconstruction within the next six months.
  • Women with any medical conditions that could hinder their ability to engage in exercise, such as decompensated heart failure, unstable ischemic heart disease, severe untreated hypertension, moderate to severe chronic obstructive pulmonary disease, aortic aneurysm, or chronic respiratory insufficiency.

结局指标

主要结局

Universal Goniometer

时间窗: 4 weeks

Hand-held dynamometer

时间窗: 4 weeks

Anthropometric measurement using inch tape

时间窗: 4 weeks

Micro Respiratory Pressure Meter

时间窗: 4 weeks

次要结局

  • DASH questionnaire
  • Harvard Step test(4 weeks)
  • WHOQOL- BREF questionnaire(4 weeks)
  • DASS-21 questionnaire(4 weeks)

研究者

发起方
Epshita kakati
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Epshita kakati

SGT University

研究点 (1)

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