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The effect of exercise on breast cancer patients* quality of life using the cmRCT design: The UMBRELLA Fit trial

The effect of exercise on breast cancer patients* quality of life using the cmRCT design: The UMBRELLA Fit trial - UMBRELLA Fit trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47246
Enrollment
130
Registered
2015-05-26
Start date
2015-11-14
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

breast cancer

Interventions

A 12-week structured exercise programme, consisting of two one-hour supervised fitness group sessions at a physiotherapist centre per week. The training programme is a combination of high intensity

Sponsors

Jullius Centrum voor Gezondheidswetenschappen en Eerstelijnsgeneeskunde
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject should first be included in UMBRELLA. The inclusion criteria of the UMBRELLA cohort are: - adult women with primary curatively treated breast cancer (stage I-III) visiting the radiotherapy department of the University Medical Center Utrecht - mentally component to sign informed consent - able to speak, read and understand Dutch;Specific citeria for the UMBRELLA Fit trial - 18-75 years of age - 12 months-18 months after inclusion in the UMBRELLA cohort - finished primary breast cancer treatment (except hormal therapy) - an inactive lifestyle - informed consent given in UMBRELLA for being invited for future research/ intervention studies;An inactive lifestyle is determined as

Exclusion criteria

Exclusion criteria: - contra-indications for exercise, e.g. neurological problems (balance, dizziness), arrhythmias, walking problems and uncontrolled high blood pressure.

Design outcomes

Primary

MeasureTime frame
The primary endpoints for this study are: quality of life (primary patient-related outcome), fatigue, and physical activity levels on the long-term.

Secondary

MeasureTime frame
Secondary outcomes are methodological: i.e. contamination, participation, retention and the composition of the study population.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)