Effect of prehabilitation on handgrip strength following axillary lymph node dissection in breast cancer patients – A randomized control trail
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. patients who have undergone prehabilitation with structured upper limb exercises have better hand grip strength after ALND as compared to those who have not.
研究概览
简要总结
Patients diagnosed with Breast carcinoma with Metastasis to I/L Lymph nodes and have undergone NACT, planned for ALND are screened according to Inclusion and exclusion criteria. Informed consents taken and selected patients are asked to choose a pre numbered sealed envelops thus divided into 2 groups, namely Prehabilitation group and Control group. Prehabilitation group is asked to follow a structured upper limb exercise routine for 6 weeks. Assessment of Handgrip strength is done once before starting prehabilitaiton, 1 day before surgery, and 1 month after surgery. Assessment is done by a blinded examiner who does not know which group the patient belongs to. Hand grip strength is measured using Camry Digital Handgrip Dynamometer (Model EH101). The participants will be seated on a chair with arm rest and hold the hand dynamometer with their shoulder relaxed, their forearm supported in a neutral position and their elbow flexed at 90 degrees. The greatest outcome for ipsilateral HGS will be recorded after 3 consecutive readings, 5 minutes apart. Following which statistical analysis of the data is done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 18 to 70 years.
- •Diagnosed with stage I to III breast cancer as per AJCC 8th edition planned for ALND or Completion ALND.
- •Patient planned for NACT as per NCCN Guidelines 4.2024.
排除标准
- •Patients undergoing Breast surgery where pectoralis muscle is involved.
- •Patients who require Flap Reconstruction of Breast.
- •Patients with a history of prior axillary surgery, breast reconstruction or prior upper limb surgical interventions, previously diagnosed musculoskeletal impairment or trauma of upper limb.
- •Pregnant and Lactating women.
结局指标
主要结局
1. patients who have undergone prehabilitation with structured upper limb exercises have better hand grip strength after ALND as compared to those who have not.
时间窗: 1 month post surgery
次要结局
未报告次要终点
研究者
Dr Aditya Arnav
All India Institute of Medical Sciences, Rishikesh