Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors
exercise
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
2 other identifiers
interventional
66
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2026
CompletedFirst Submitted
Initial submission to the registry
March 7, 2026
CompletedFirst Posted
Study publicly available on registry
March 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
March 12, 2026
March 1, 2026
1.3 years
March 7, 2026
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Skeletal Muscle Mass Index (SMI)
Skeletal Muscle Mass Index (SMI) is calculated by dividing total skeletal muscle mass (kg), as measured by bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare), by the square of the height (m²). Higher scores indicate greater muscle mass relative to height (better outcome).
16 weeks
Secondary Outcomes (10)
Functional Battery: Change from Baseline in Handgrip Strength
16 weeks
Functional Battery: Change from Baseline in 4-Meter Gait Speed
16 weeks
Functional Battery: Change from Baseline in Timed Up & Go (TUG) Test
16 weeks
Functional Battery: Change from Baseline in 30-Second Chair Stand Test
16 weeks
Body Composition: Change from Baseline in Body Fat Mass
16 weeks
- +5 more secondary outcomes
Study Arms (2)
Facility-Based Resistance and Relaxation
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Valeria Chiulead
Study Sites (1)
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
New Taipei City, Xindian Dist, 231, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
March 7, 2026
First Posted
March 11, 2026
Study Start
January 5, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will become available 6 months after the primary manuscript is published in a peer-reviewed journal and will remain available for a period of 5 years.
- Access Criteria
- Data will be shared with qualified academic researchers who provide a methodologically sound proposal. Proposals must be approved by the lead investigator's Institutional Review Board (IRB) or Ethics Committee.
De-identified individual participant data that underlie the results reported in this article will be available to researchers who provide a methodologically sound proposal. Proposals may be submitted beginning 9 months and ending 36 months following article publication to the corresponding author. Data will be shared after approval of the proposal and the signing of a data access agreement.