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
Secondary identifying numbers CRUK grant C8305/A3902
Submission date
20/09/2005
Registration date
20/01/2006
Last edited
10/09/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/exercise-therapy-for-women-having-treatment-for-early-stage-breast-cancer

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesExercise 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) studiedBreast cancer
InterventionIntervention: 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 typeOther
Primary outcome measureFunctional assessment of cancer therapy - general (FACT G) - measure of Quality of life
Secondary outcome measures1. 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 study start date01/01/2004
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants182
Key inclusion criteriaAny women undergoing treatment for early stage breast cancer.
Key exclusion criteriaAny 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 enrolment01/01/2004
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Dept Sport Culture and Art
Glasgow
G13 1PP
United Kingdom

Sponsor information

University of Strathclyde (UK)
University/education

Lynda Frew
Contracts Officer
Research & Consultancy Services
University of Strathclyde
50 George Street
Glasgow
G1 1QE
Scotland
United Kingdom

Phone +44 (0)141 548 3306
Website lynda.frew@strath.ac.uk
ROR logo "ROR" https://ror.org/00n3w3b69

Funders

Funder type

Charity

Cancer Research UK - CRUK grant C8305/A3902

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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