A randomised controlled trial of a supervised exercise programme as a rehabilitation treatment for women receiving early stage breast cancer treatment

ISRCTN	ISRCTN12587864
DOI	https://doi.org/10.1186/ISRCTN12587864
Protocol serial number	CRUK grant C8305/A3902
Sponsor	University of Strathclyde (UK)
Funder	Cancer Research UK - CRUK grant C8305/A3902

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Prof Nanette Mutrie
Scientific

Dept Sport Culture and Art
University of Strathclyde
76 Southbrae Drive
Glasgow
G13 1PP
United Kingdom

Phone	+44 (0)1419503137
Email	nanette.mutrie@strath.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Exercise is an effective intervention during cancer treatment to decrease fatigue levels and improve quality of life and physical functioning
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast cancer
Intervention	Intervention: Group exercise class twice a week for 12 weeks The control group will receive usual care from the healthcare team and will complete the questionnaires and walking test at baseline, week 12 and 6 months post intervention. At the end of the study period (9 months) they will be assisted by the senior researcher in constructing their own personalised exercise plan and invited to join the Glasgow GP exercise referral scheme.
Intervention type	Other
Primary outcome measure(s)	Functional assessment of cancer therapy - general (FACT G) - measure of Quality of life
Key secondary outcome measure(s)	1. FACT - breast cancer specific 2. FACT - fatigue 3. FACT - endocrine symptoms 4. Beck Depression Inventory (BDI) 5. Positive and Negative Affects Scale (PANAS) 6. 12 minute walk test 7. Scottish physical activity questionnaire (SPAQ)
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	182
Key inclusion criteria	Any women undergoing treatment for early stage breast cancer.
Key exclusion criteria	Any woman with concurrent major health problems such as uncontrolled cardiac or hypertensive disease, respiratory disease, cognitive dysfuntion or already exercising vigorously three times a week for 20 minutes or more.
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2005

Dept Sport Culture and Art

Glasgow
G13 1PP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/03/2007		Yes	No