Prehabilitation Program Based on Health Education and Nordic Walking to Reduce Musculoskeletal Impairments in Women Undergoing Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
研究概览
简要总结
Prehabilitation for women diagnosed with breast cancer is commonly not part of the clinical pathways as little time (usually a few days) is left between diagnosis and surgery. However, a great proportion of these patients will undergo neoadjuvant chemotherapy which provides a window opportunity to improve patients' physical status to withstand surgery and minimize post-operative musculoskeletal complications associated with surgery.
To this end, the aim of this study is to assess the efficacy of a prehabilitation program consisting of health education and a supervised nordic walking-based intervention in women diagnosed with breast cancer currently undergoing neoadjuvant chemotherapy to decrease post-operative musculoskeletal impairments and improve functionality of the affected arm.
The study is an open-label, single-blind randomised controlled trial conducted at one tertiary hospital. Women diagnosed with breast cancer scheduled for surgery and currently undergoing chemotherapy will be randomised to either usual care (UC) or prehabilitation (PREHAB). Patients will be assessed for eligibility during the fourth out of six course of chemotherapy. Those randomised to the PREHAB group will participate in a supervised group-based nordic walking intervention twice weekly during 8 weeks (approximately 16 sessions). In addition, participants will receive written information regarding the benefits of exercise during cancer treatment and surveillance. Patients will be assessed prior to surgery as well as at 1, 3 and 6 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of breast cancer scheduled for surgery with or without lymphadenectomy
- •Candidates to receive neoadjuvant chemotherapy
- •Not currently undergoing any other physical therapy therapies or treatments
排除标准
- •Cognitive impairment or inability to read Catalan or Spanish
- •Prior diagnosis of shoulder impairment or injury
- •Major musculoskeletal, neurological or cardiorespiratory limitations to prevent participation in the exercise program
研究组 & 干预措施
Usual Care
Patients allocated to this arm will continue with their schedule chemotherapy with no additional intervention
Prehabilitation
Patients allocated to this arm will participate in a weekly group-based exercise intervention (nordic walking) and receive health education through a booklet, videos of the exercises and face-to-face sessions prior to each nordic walking session. Chemotherapy will continue as scheduled.
干预措施: Group-based Nordic Walking Exercise Program (Behavioral)
结局指标
主要结局
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
时间窗: Six months post-surgery
Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
时间窗: Pre-Surgery (one week)
Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
时间窗: One month post-surgery
Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
时间窗: Three months post-surgery
Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability)
次要结局
- Pain severity(Six months post-surgery)
- Health-Related Quality of Life(Six months post-surgery)
- Functional capacity(Six months post-surgery)
- Upper arm volume(Six months post-surgery)
- Range of Movement (ROM)(Six months post-surgery)
- Adherence(Pre-Surgery (one week))
- Handgrip Strength(Six months post-surgery)
- Physical Activity(Six months post-surgery)
- Upper arm volume(Pre-Surgery (one week))
- Upper arm volume(One month post-surgery)
- Upper arm volume(Three months post-surgery)
- Range of Movement (ROM)(Pre-Surgery (one week))
- Range of Movement (ROM)(One month post-surgery)
- Range of Movement (ROM)(Three months post-surgery)
- Pain severity(Pre-Surgery (one week))
- Pain severity(One month post-surgery)
- Pain severity(Three months post-surgery)
- Handgrip Strength(Three months post-surgery)
- Health-Related Quality of Life(Pre-Surgery (one week))
- Health-Related Quality of Life(One month post-surgery)
- Health-Related Quality of Life(Three months post-surgery)
- Handgrip Strength(Pre-Surgery (one week))
- Handgrip Strength(One month post-surgery)
- Functional capacity(Pre-surgery (one week))
- Functional capacity(One month post-surgery)
- Functional capacity(Three months post-surgery)
- Physical Activity(Pre-surgery (one week))
- Physical Activity(One month post-surgery)
- Physical Activity(Three months post-surgery)
研究者
Raquel Sebio
Principal Investigator
Universitat Pompeu Fabra