A randomised controlled trial of a supervised exercise programme as a rehabilitation treatment for women receiving early stage breast cancer treatment
ISRCTN | ISRCTN12587864 |
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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
Contact information
Prof Nanette Mutrie
Scientific
Scientific
Dept Sport Culture and Art
University of Strathclyde
76 Southbrae Drive
Glasgow
G13 1PP
United Kingdom
Phone | +44 (0)1419503137 |
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nanette.mutrie@strath.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 study start date | 01/01/2004 |
Completion date | 31/12/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 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 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Dept Sport Culture and Art
Glasgow
G13 1PP
United Kingdom
G13 1PP
United Kingdom
Sponsor information
University of Strathclyde (UK)
University/education
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 |
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Website | lynda.frew@strath.ac.uk |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |