Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multimodal Resistance and Relaxation Training, Home-Based Resistance Exercise Training.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms, Sarcopenia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Detailed description
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.
Interventions
- Behavioral Multimodal Resistance and Relaxation Training
A 16-week multimodal program consisting of resistance exercise and relaxation training. Participants undergo two sessions per week: one weekly session is conducted under the supervision of a physical therapist at Taipei Tzu Chi Hospital, and one weekly session is self-directed and performed by the participant in a home setting. The resistance exercise portion utilizes progressive elastic band training - Behavioral Home-Based Resistance Exercise Training
A 16-week self-directed resistance exercise program. The intervention consists of two sessions per week performed independently by the participant in a home setting. The exercise regimen utilizes progressive elastic band training and is conducted without direct therapist supervision
Primary outcome measures
- Change from Baseline in Skeletal Muscle Mass Index (SMI) [Time frame: 16 weeks]
Secondary outcome measures (10)
- Functional Battery: Change from Baseline in Handgrip Strength [Time frame: 16 weeks]
- Functional Battery: Change from Baseline in 4-Meter Gait Speed [Time frame: 16 weeks]
- Functional Battery: Change from Baseline in Timed Up & Go (TUG) Test [Time frame: 16 weeks]
- Functional Battery: Change from Baseline in 30-Second Chair Stand Test [Time frame: 16 weeks]
- Body Composition: Change from Baseline in Body Fat Mass [Time frame: 16 weeks]
- Body Composition: Change from Baseline in Limb-to-Trunk Lean Mass Ratio [Time frame: 16 weeks]
- Body Composition: Change from Baseline in Arm-to-Leg Lean Mass Ratio [Time frame: 16 weeks]
- HRQoL: Change from Baseline in EORTC QLQ-C30 Score [Time frame: 16 weeks]
- HRQoL: Change from Baseline in EORTC QLQ-BR45 Score [Time frame: 16 weeks]
- HRQoL: Change from Baseline in SarQoL Score [Time frame: 16 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation — New Taipei City
Identifiers
NCT: NCT07465393 · 13-IRB110 · TCRD-TPE-114-C1-2