Condition category
Cancer
Date applied
20/09/2005
Date assigned
20/01/2006
Last edited
10/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

lynda.frew@strath.ac.uk

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

  1. 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.

Additional files

Editorial Notes