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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings