The SHAPE study.

Physical activity and breast cancer risk in postmenopausal women (the SHAPE study).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22500

Enrollment

189

Registered

2006-07-03

Start date

2005-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

1. Intervention group – participants in this group will participate in an 1-year moderate intensity exercise programme

2. Control group – participants.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women aged 50 –69 year; 2. > 12 months since last menses; 3. Non-smokers (at least 12 months); 4. Sedentary: < 2 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 [83;84]; 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.

Exclusion criteria

Exclusion criteria: 1. Use of hormone replacement or oral contraceptives in past 6 months; 2. Morbidly obese (BMI > 40); 3. BMI < 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 5 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.

Design outcomes

Primary

Measure	Time frame
Endogenous hormone levels (sex steroid hormones, insulin).	—

Secondary

Measure	Time frame
1. Physical fitness, weight and the amount of total and intra-abdominal fat; 2. Lifestyle factors: habitual physical activity, diet, alcohol consumption and medication use.	—

Contacts

Public ContactEvelyn Monninkhof

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

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

Outcome results