跳至主要内容
临床试验/CTRI/2025/12/098842
CTRI/2025/12/098842尚未招募不适用

Effectiveness of prehabilitation and Lymphedema education on clinical and Functional outcomes among Non-metastatic Breast cancer patients

Kavitha V1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Shoulder ROM, Grip Strength, SPADI questionnaire

研究概览

简要总结

Subjects who met inclusion criteria will be taken for this study from the Department of Medical Oncology and Department of Surgical Oncology in Sri Ramachandra Hospital. Subjects will be explained about the study and outcome of the study and written informed consent would be obtained. Based on the inclusion criteria subjects will be divided into 2 groups. Group A (Prehabilitation group) and Group B (Standard Physiotherapy group). Group A will receive prehabilitation and lymphedema education preoperatively 1 – 2 weeks prior to surgery by direct 1:1 education for about 30-45 minutes and participants are instructed to follow the exercises at home and are monitored through tele-communication and standard post-operative physiotherapy care will be given following surgery. Group B will receive standard physiotherapy care and lymphedema education. Both groups will be assessed shoulder ROM using goniometer, grip strength using handheld dynamometer, shoulder functional outcome using SPADI questionnaire, and arm circumference using inch tape during preoperatively (Experimental group: 1 – 2 weeks prior to surgery) (Control group: 1 – 2 days prior to surgery), post-operative day 1, post drain removal, and post 1 and 2 months of surgery. Awareness of lymphedema will be assessed by using Lymphedema Knowledge Survey before and after giving lymphedema education.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Subjects aged between 25 and 60 years who comprehend to commands 2) Subjects who planned for Modified radical mastectomy, Simple mastectomy and Breast conserving surgery with Axillary lymphnode dissection.

排除标准

  • Subjects with Metastatic breast cancer 2) Subjects who planned for Lumpectomy, Wide local excision, Flap reconstruction 3) Subjects undergoing Neoadjuvant Radiation therapy 4) Subjects with comorbidities of cardiopulmonary, neurological and musculoskeletal conditions.

结局指标

主要结局

Shoulder ROM, Grip Strength, SPADI questionnaire

时间窗: Baseline, POD 1, Post drain removal, Post 1 month and Post 2 months of surgery

次要结局

  • Arm Circumference, Lymphedema Knowledge Survey(Baseline (1-2days prior to surgery), POD 1, Post drain removal, Post 1 month and Post 2 month)

研究者

发起方
Kavitha V
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Kavitha V

Department of Oncology Physiotherapy

研究点 (1)

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