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A randomised controlled trial of a supervised exercise programme as a rehabilitation treatment for women receiving early stage breast cancer treatment
DOI 10.1186/ISRCTN12587864
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial of a supervised exercise programme as a rehabilitation treatment for women receiving early stage breast cancer treatment
Scientific title
Acronym N/A
Serial number at source CRUK grant C8305/A3902
Study hypothesis Exercise is an effective intervention during cancer treatment to decrease fatigue levels and improve quality of life and physical functioning
Lay summary http://cancerhelp.cancerresearchuk.org/trials/exercise-therapy-for-women-having-treatment-for-early-stage-breast-cancer
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Breast cancer
Participants - inclusion criteria Any women undergoing treatment for early stage breast cancer.
Participants - 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.
Anticipated start date 01/01/2004
Anticipated end date 31/12/2005
Status of trial Completed
Patient information material
Target number of participants 182
Interventions 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.
Primary outcome measure(s) Functional assessment of cancer therapy - general (FACT G) - measure of Quality of life
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)
Sources of funding Cancer Research UK - CRUK grant C8305/A3902
Trial website
Publications 1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17307761
Contact name Prof  Nanette  Mutrie
  Address Dept Sport Culture and Art
University of Strathclyde
76 Southbrae Drive
  City/town Glasgow
  Zip/Postcode G13 1PP
  Country United Kingdom
  Tel +44 (0)1419503137
  Email nanette.mutrie@strath.ac.uk
Sponsor University of Strathclyde (UK)
  Address Lynda Frew
Contracts Officer
Research & Consultancy Services
University of Strathclyde
50 George Street
  City/town Glasgow
  Zip/Postcode G1 1QE
  Country United Kingdom
  Tel +44 (0)141 548 3306
  Fax +44 (0)141 552 4409
  Sponsor website: lynda.frew@strath.ac.uk
Date applied 20/09/2005
Last edited 10/09/2012
Date ISRCTN assigned 20/01/2006
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