Long-term Evaluation of the Body Composition and the Impact of Resistance and Relaxation Exercise on Muscle Mass and Quality of Life in Patients With Breast Cancer
| Registry | NCT07465393, acronym exercise |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 66 (Estimated) |
| Sponsor | Valeria Chiu (Other) |
| Conditions | Breast Neoplasms, Sarcopenia |
| Interventions | Multimodal Resistance and Relaxation Training, Home-Based Resistance Exercise Training (Behavioral) |
| Dates | start 2026-01-05, primary completion 2027-04-30 (estimated), completion 2027-04-30 (estimated), first posted 2026-03-11, last updated 2026-03-12 |
| Locations | 1 site in Taiwan |
Related Papers Related Patents Related Grants Related Experts
All trials for Breast Neoplasms All trials for Sarcopenia All trials of Multimodal Resistance and Relaxation Training All trials of Home-Based Resistance Exercise Training
This study evaluates the comparative effectiveness of a multi-modal facility-based rehabilitation program (therapist-led resistance exercise and relaxation training) versus a self-directed home-based resistance exercise program in post-treatment breast cancer survivors. Participants in both intervention groups will complete a 16-week program consisting of two exercise sessions per week.The multimodal, therapist-led approach is hypothesized to result in superior improvements in physical performance and quality of life outcomes compared to self-directed home exercise
Breast cancer treatments, including chemotherapy and radiotherapy, are associated with sarcopenia, a loss of muscle mass and strength, which increases toxicity, surgical complications, and mortality risk. While resistance exercise is known to mitigate muscle loss, the synergistic effect of adding relaxation techniques to address the psychological and neuromuscular tension of cancer treatment is not well established. This study investigates the comparative effectiveness of a multi-modal, facility-based program (elastic band resistance exercise combined with progressive muscle relaxation) versus a self-directed home-based elastic band resistance exercise program. The supervised, multi-modal intervention is hypothesized to offer superior results in muscle mass, physical performance, and quality of life compared to isolated resistance training.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Facility-Based Resistance and Relaxation | Experimental | Behavioral: Multimodal Resistance and Relaxation Training | Participants engage in a 16-week multimodal rehabilitation program at Taipei Tzu Chi Hospital. The intervention is comprised of one weekly therapist-led session and one weekly self-directed home session (totaling two sessions per week) involving elastic band resistance exercise and relaxation training |
| Home-Based Resistance Exercise | Active comparator | Behavioral: Home-Based Resistance Exercise Training | Participants perform a 16-week self-directed elastic band resistance exercise program. The intervention consists of two weekly home-based sessions using elastic bands, performed without therapist supervision. |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: * Histologically confirmed primary breast cancer * Stage I-III non-metastatic breast cancer following lumpectomy or mastectomy * Completed adjuvant chemotherapy (with or without radiotherapy) * Age ≥ 18 years * Able to understand and follow the study protocol * Willingness to attend facility-based exercise training. Exclusion Criteria: * Metastatic (Stage IV) breast cancer * Morbid obesity (BMI > 40 kg/m²) * Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 99 mmHg) * Presence of implantable medical devices (e.g., pacemakers, nerve stimulators) * Presence of metallic surgical implants (e.g., total hip or knee replacements) that interfere with assessment devices * Contraindications for resistance training (e.g., acute infectious disease, severe cardiac disease, severe respiratory insufficiency) * Concurrent malignant diseases * Current participation in intense systematic exercise training (defined as at least 1 hour, twice per week) * Previous participation in an exercise intervention clinical trial.
| Facility | City | Country | Status |
|---|---|---|---|
| Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | New Taipei City, Xindian Dist | Taiwan | Recruiting |