ISRCTN ISRCTN11633173
DOI https://doi.org/10.1186/ISRCTN11633173
Secondary identifying numbers N/A
Submission date
26/09/2006
Registration date
26/09/2006
Last edited
25/08/2009
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

Not provided at time of registration

Contact information

Dr Evelyn Monninkhof
Scientific

University Medical Center Utrecht (UMCU)
Julius Center for Health Sciences and Primary Care
Stratenum 6.131
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone +31 (0)30 2509379
Email e.monninkhof@umcutrecht.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study acronymSHAPE: Sex Hormones and Physical Exercise
Study objectivesWe hypothesise that exercise may reduce risk of breast cancer, either directly or indirectly through a reduction in abdominal fat mass, by favouring the sex hormone profile and decreased insulin. Because the association between breast cancer and endogenous estrogens is rather convincing, we designed the Sex Hormones and Physical Exercise (SHAPE) study on the effects of physical activity on these hormones.

Furthermore, since androgens and insulin are suspicious risk factors for breast cancer, the effects of physical activity on these hormone levels are also investigated. Since the intervention programme is aimed at maximising fat loss, we can also investigate whether a potential relation between physical activity and endogenous hormones is mediated by the amount of total body fat or abdominal fat. If change in exercise level has a beneficial effect on the sex hormone and metabolic profile of postmenopausal women, increasing exercise is a possible breast cancer protective intervention.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedReducing the risk of breast cancer
Intervention1. Intervention group: participants in this group will participate in an one year moderate intensity exercise programme
2. Control group: participants in this group will receive care as usual
Intervention typeOther
Primary outcome measureEndogenous hormone levels (sex steroid hormones, insulin).
Secondary outcome measures1. Physical fitness, weight and the amount of total and intra-abdominal fat
2. Lifestyle factors: habitual physical activity, diet, alcohol consumption and medication use
Overall study start date01/01/2005
Completion date01/09/2006

Eligibility

Participant type(s)Patient
Age groupSenior
SexFemale
Target number of participants189
Key inclusion criteria1. Women aged 50 to 69 years
2. More than 12 months since last menses
3. Non-smokers (at least 12 months)
4. Sedentary: less than two hours per week of moderate sport activity (e.g. tennis, swimming, running, aerobics, fitness, volleyball) and not adherent to the international physical activity guideline. The international physical activity guideline states that every adult should accumulate 30 minutes or more of at least moderately intense physical activity for at least five days per week
4. Knowledge of the Dutch language
5. Agreement to be randomly assigned to either the exercise intervention or control group
6. Informed consent to participate in all screening and study activities
Key exclusion criteria1. Use of hormone replacement or oral contraceptives in past six months
2. Morbidly obese (Body Mass Index [BMI] more than 40)
3. BMI less than 22
4. Currently on or planning to go on a strict diet
5. Ever diagnosed with breast cancer
6. Diagnosis of other types of cancer in the past five years
7. Diabetes mellitus or other endocrine related diseases
8. Disorders or diseases (locomotor, optical, neurological, mental) that might impede the participation in the exercise programme
9. Alcohol or drug abuse
10. Maintenance use of corticosteroids
11. Use of beta blockers
Date of first enrolment01/01/2005
Date of final enrolment01/09/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Utrecht (UMCU)
Utrecht
3508 GA
Netherlands

Sponsor information

The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (The Netherlands)
Charity

P.O. Box 75508
Amsterdam
1070 AM
Netherlands

ROR logo "ROR" https://ror.org/0368jnd28

Funders

Funder type

Charity

Dutch Cancer Society (Netherlands)

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?
Protocol article protocol 04/09/2007 Yes No
Results article results 20/09/2009 Yes No