Table 1.

WHO trial registration data set

Data category	Information
Primary registry and trial identifying number	ISRCTN35358984
Date of registration in primary registry	Project number 13/84/10
Secondary identifying numbers	Health Technology Assessment (HTA)
Source of monetary or material support	National Institute for Health Research, HTA
Joint sponsor	University of Warwick/University Hospitals Coventry and Warwickshire NHS Trust
Contact for public queries	prosper@warwick.ac.uk
Contact for scientific queries	Professor Julie Bruce, Warwick Clinical Trials Unit, University of Warwick
Public title	Exercise to prevent shoulder problems in patients undergoing breast cancer treatment
Scientific title	The PRevention Of Shoulder ProblEms tRial: a randomised controlled clinical trial comparing physiotherapy-led exercise vs usual care in women at high risk of shoulder problems after breast cancer surgery
Countries of recruitment	UK
Health condition or problem studied	Breast cancer
Interventions	Advice only: breast cancer care leaflets Comparator: physiotherapy-led structured exercise programme incorporating behavioural strategies
Key inclusion and exclusion criteria	Age: 18 years or over, no upper age restriction Sex: female Inclusion: confirmed invasive/non-invasive primary breast cancer schedule for surgical excision, at high risk of shoulder problems as defined by criteria given in table 2 Exclusion: males, and women with exclusion criteria as described in table 2.
Study type	Interventional Allocation: randomised; individual assignment Primary purpose: prevention Phase III
Date of first enrolment	January 2016
Target sample size	350
Recruitment status	Recruiting to July 2017
Primary outcome	Arm, shoulder and hand function as measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 12 months
Key secondary outcomes	DASH subscales, pain (acute, chronic, neuropathic), health-related quality of life, surgical site infection, lymphoedema and other complications, healthcare resource use. Exercise/activity data to inform adherence to interventions