Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors (exercise)

March 11, 2026 updated by: Valeria Chiu

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Xindian Dist
      • New Taipei City, Xindian Dist, Taiwan, 231
        • Recruiting
        • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Facility-Based Resistance and Relaxation
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
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
Active Comparator: Home-Based Resistance Exercise
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Skeletal Muscle Mass Index (SMI)
Time Frame: 16 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Battery: Change from Baseline in 30-Second Chair Stand Test
Time Frame: 16 weeks
Lower extremity functional strength measured as the total number of stands completed in 30 seconds.
16 weeks
Functional Battery: Change from Baseline in Handgrip Strength
Time Frame: 16 weeks
Handgrip strength of the dominant hand measured using a hydraulic dynamometer (LiTE - 200 lb Capacity, USA); the highest of three trials is reported. Higher scores indicate greater upper extremity strength (better outcome).
16 weeks
Functional Battery: Change from Baseline in 4-Meter Gait Speed
Time Frame: 16 weeks
4-meter gait speed (m/s) measured using a standardized timed walk test. Higher scores indicate faster walking speed (better outcome).
16 weeks
Functional Battery: Change from Baseline in Timed Up & Go (TUG) Test
Time Frame: 16 weeks
Functional mobility and balance measured using the Timed Up & Go (TUG) test; time recorded in seconds. Higher scores (longer time taken) indicate poorer functional mobility and balance (worse outcome).
16 weeks
Body Composition: Change from Baseline in Body Fat Mass
Time Frame: 16 weeks
Body fat mass (kg) measured using bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). Higher scores indicate greater absolute body fat (worse outcome in the context of sarcopenia/obesity).
16 weeks
Body Composition: Change from Baseline in Limb-to-Trunk Lean Mass Ratio
Time Frame: 16 weeks
The ratio of total limb lean soft tissue (kg) to trunk lean soft tissue (kg) derived from segmental bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). Higher scores indicate a higher proportion of appendicular muscle relative to the trunk (better outcome).
16 weeks
Body Composition: Change from Baseline in Arm-to-Leg Lean Mass Ratio
Time Frame: 16 weeks
The ratio of total arm lean soft tissue (kg) to total leg lean soft tissue (kg) derived from segmental bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). Higher scores indicate greater upper limb muscle mass relative to lower limb mass.
16 weeks
HRQoL: Change from Baseline in EORTC QLQ-C30 Score
Time Frame: 16 weeks
Quality of life measured by the EORTC QLQ-C30; raw scores are transformed to a standardized 0-100 scale. For Global Health Status and Functional scales, higher scores indicate better quality of life/functioning (better outcome). For Symptom scales/items, higher scores indicate a higher level of symptomatology/problems (worse outcome).
16 weeks
HRQoL: Change from Baseline in EORTC QLQ-BR45 Score
Time Frame: 16 weeks
Breast cancer-specific quality of life measured by the EORTC QLQ-BR45; raw scores are transformed to a standardized 0-100 scale. For Functional scales (e.g., Body Image, Sexual Functioning), higher scores indicate a higher/healthier level of functioning (better outcome). For Symptom scales/items (e.g., Systemic Therapy Side Effects, Arm Symptoms), higher scores indicate a higher level of symptomatology/problems (worse outcome).
16 weeks
HRQoL: Change from Baseline in SarQoL Score
Time Frame: 16 weeks
Sarcopenia-specific quality of life measured by the SarQoL questionnaire; composite score transformed to a 0-100 scale. Higher scores indicate a better quality of life (better outcome).
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valeria Chiu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

March 7, 2026

First Submitted That Met QC Criteria

March 7, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-IRB110
  • TCRD-TPE-114-C1-2 (Other Grant/Funding Number: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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