Clinical trial · Interventional
Exercise Training in Women With Metastatic Breast Cancer
Randomized Controlled Trial of a Combined Exercise Training Program on Physical Function and Quality of Life in Women With Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of the study is to evaluate the effects of exercise on physical function, physical fitness, and body composition, with the main components including muscular strength, cardiorespiratory fitness, muscle mass, fat mass, and fat-free mass. The secondary objectives are to examine exercise adherence and the effects of exercise on health-related quality of life (HRQoL), cancer-related fatigue, and sleep quality. Additionally, the feasibility and safety of the exercise program will be assessed.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise group
- description
- The exercise group will be instructed to complete 48 supervised, multicomponent physical training sessions over a 24-week period, with a frequency of two sessions per week on non-consecutive days.
- interventionNames
- Other: Exercise
- type
- NO_INTERVENTION
- label
- Control group
- description
- Participants in the waitlist control group received standard medical care, without any exercise program or specific exercise recommendations. To maintain contact with the investigators and minimize study dropout, the waitlist control group received general health information through monthly online meetings.
Primary outcomes (3)
- measure
- Cardiorespiratory endurance and functional capacity
- timeFrame
- Baseline and week 24 (post exercise intervention)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged ≥ 18 years; * Confirmed diagnosis of stage IV (metastatic) breast cancer; * Currently undergoing medical treatment; * Willingness and functional independence to participate in the exercise program; * Medical clearance to engage in structured physical exercise. Exclusion Criteria: * Presence of unstable bone metastases. * Untreated or symptomatic brain metastases; * Evidence of severe cardiovascular disease identified by electrocardiogram (ECG); * Severe active infection; * Uncontrolled severe respiratory insufficiency or dependence on supplemental oxygen at rest or during exercise; * Uncontrolled severe pain; * Any other medical condition contraindicating participation in physical exercise; * Conditions that impair adherence to study procedures or the ability to provide informed consent; * Pregnancy.
References
Publications (0)
Data not yet available