Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Prof Nanette Mutrie
ORCID ID
Contact details
Dept Sport Culture and Art
University of Strathclyde
76 Southbrae Drive
Glasgow
G13 1PP
United Kingdom
+44 (0)1419503137
nanette.mutrie@strath.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CRUK grant C8305/A3902
Study information
Scientific title
Acronym
Study hypothesis
Exercise is an effective intervention during cancer treatment to decrease fatigue levels and improve quality of life and physical functioning
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Functional assessment of cancer therapy - general (FACT G) - measure of Quality of life
Secondary outcome measures
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)
Overall trial start date
01/01/2004
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Any women undergoing treatment for early stage breast cancer.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
182
Participant 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.
Recruitment start date
01/01/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept Sport Culture and Art
Glasgow
G13 1PP
United Kingdom
Sponsor information
Organisation
University of Strathclyde (UK)
Sponsor details
Lynda Frew
Contracts Officer
Research & Consultancy Services
University of Strathclyde
50 George Street
Glasgow
G1 1QE
United Kingdom
+44 (0)141 548 3306
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK - CRUK grant C8305/A3902
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17307761
Publication citations
-
Results
Mutrie N, Campbell AM, Whyte F, McConnachie A, Emslie C, Lee L, Kearney N, Walker A, Ritchie D, Benefits of supervised group exercise programme for women being treated for early stage breast cancer: pragmatic randomised controlled trial., BMJ, 2007, 334, 7592, 517, doi: 10.1136/bmj.39094.648553.AE.