Exercise to prevent shoulder problems (PROSPER) (V1.0)
Research type
Research Study
Full title
Exercise to prevent shoulder problems in patients undergoing breast cancer treatment: The PRevention Of Shoulder ProblEms TRial (PROSPER)
IRAS ID
161606
Contact name
Julie Bruce
Contact email
Sponsor organisation
University of Warwick
ISRCTN Number
ISRCTN35358984
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Most women with breast cancer have surgery to the breast and axilla (armpit); further treatment may include radiotherapy and/or chemotherapy. Cancer treatment can affect the muscles, nerves and lymphatic vessels in the shoulder and upper body resulting in musculoskeletal problems such as limited range of motion, weakness, persistent pain, altered sensations and lymphoedema (swelling due to accumulated lymphatic fluid). A high proportion of women have symptoms in their arm or shoulder up to 3 years after treatment. Persistent symptoms can delay recovery, limit daily activities, and reduce quality of life. Research suggests that a structured exercise programme, commenced within days or weeks of surgery, can improve shoulder movement and reduce complications. Usual NHS care is to provide information leaflets to all women recommending upper body movements after breast cancer surgery. Current NHS pressures mean that many cancer centres implement the "23-hour" care pathway, where most women are discharged hours after surgery without any physiotherapy support. Women having extensive cancer treatment (e.g axillary clearance surgery/ radiotherapy) are at greater risk of developing shoulder problems and may benefit from a physiotherapy-led prevention programme. The PROSPER trial seeks to prevent shoulder problems in high risk women treated for breast cancer. PROSPER will investigate the clinical and cost-effectiveness of early supervised exercise compared to usual care on outcomes of shoulder/arm function, health-related quality of life, chronic pain and other postoperative complications, after treatment for breast cancer. Women at high risk of shoulder problems will eligible to participate. This 4-year study will recruit 350 women from approximately 10 clinical centres (n=175 usual care/n=175 exercise programme). An internal pilot study and qualitative interviews will be conducted to refine risk criteria, to determine recruitment pathways and to assess the acceptability of the exercise intervention.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
15/WM/0224
Date of REC Opinion
13 Jul 2015
REC opinion
Favourable Opinion