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Breast NeoplasmsexerciseNCT07465393

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

A study testing Multimodal Resistance and Relaxation Training and Home-Based Resistance Exercise Training in people with Breast Neoplasms and Sarcopenia, run by Valeria Chiu at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms, Sarcopenia
What is being tested?
Multimodal Resistance and Relaxation Training and Home-Based Resistance Exercise Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTaiwan
Study dates
5 Jan 2026to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Valeria Chiu contact

+886266289779 ext. 67702

haydenbell28@gmail.com

Taiwan1 site, 1 recruiting

  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    New Taipei City, Xindian Dist, 231

    Valeria Chiu, +886266289779 ext. 67702, haydenbell28@gmail.com

    Recruiting

Other trials in Taiwan

About this study

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

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

Read the 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.

Being tested
Multimodal Resistance and Relaxation Training, Home-Based Resistance Exercise Training
Keywords
Elastic Band Resistance Training, Progressive Muscle Relaxation, Breast Cancer Survivors, Sarcopenia, Quality of life
Medical subject headings
Breast Neoplasms, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimodal Resistance and Relaxation TrainingBehavioural

    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

  • Home-Based Resistance Exercise TrainingBehavioural

    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

Study groups in NCT07465393
Study groupRoleWhat they receive
Facility-Based Resistance and RelaxationExperimentalParticipants 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
Receives: Behavioral: Multimodal Resistance and Relaxation Training
Home-Based Resistance ExerciseActive 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.
Receives: Behavioral: Home-Based Resistance Exercise Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 16 weeks

Secondary outcomes (10)

  1. Functional Battery: Change from Baseline in Handgrip Strength

    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).

    Measured: 16 weeks

  2. Functional Battery: Change from Baseline in 4-Meter Gait Speed

    4-meter gait speed (m/s) measured using a standardized timed walk test. Higher scores indicate faster walking speed (better outcome).

    Measured: 16 weeks

  3. Functional Battery: Change from Baseline in Timed Up & Go (TUG) Test

    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).

    Measured: 16 weeks

  4. Functional Battery: Change from Baseline in 30-Second Chair Stand Test

    Lower extremity functional strength measured as the total number of stands completed in 30 seconds.

    Measured: 16 weeks

  5. Body Composition: Change from Baseline in Body Fat Mass

    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).

    Measured: 16 weeks

  6. Body Composition: Change from Baseline in Limb-to-Trunk Lean Mass Ratio

    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).

    Measured: 16 weeks

  7. Body Composition: Change from Baseline in Arm-to-Leg Lean Mass Ratio

    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.

    Measured: 16 weeks

  8. HRQoL: Change from Baseline in EORTC QLQ-C30 Score

    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).

    Measured: 16 weeks

  9. HRQoL: Change from Baseline in EORTC QLQ-BR45 Score

    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).

    Measured: 16 weeks

  10. HRQoL: Change from Baseline in SarQoL Score

    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).

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2026
  2. Study start5 Jan 2026
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07465393
Sponsor's protocol ID
13-IRB110
Other IDs
TCRD-TPE-114-C1-2
Acronym
exercise
Status last verified
Mar 2026
First submitted
7 Mar 2026
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal Resistance and Relaxation Training and Home-Based Resistance Exercise Training in people with Breast Neoplasms and Sarcopenia, run by Valeria Chiu at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Valeria Chiu (+886266289779 ext. 67702, haydenbell28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Skeletal Muscle Mass Index (SMI) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07465393.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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