Breast Cancer SurvivorsNCT07045961
Concurrent Exercise in Combination With Music Listening in Female Breast Cancer Survivors
A study testing Supervised Station-Based Strength Circuit Training & Self-directed aerobic training and Music Medicine in people with Breast Cancer Survivors, run by Ana Trigueros Murillo at 1 site in Spain.
Trial summary
This clinical trial aims to compare the effects of a concurrent physical exercise program (aerobic and resistance training) combined with music medicine versus exercise alone on self-perception (self-esteem and body image), physical condition (strength, fatigue, cardiovascular endurance) and general well-being… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- Supervised Station-Based Strength Circuit Training & Self-directed aerobic training and Music Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2025to Jul 2026
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged between 18 and 75 years with a prior diagnosis of stage 0-III breast cancer.
- Women currently in the survivorship phase of the disease, regardless of the type of medical or surgical treatment received.
- A minimum of six months must have elapsed since the completion of primary treatment.
Who cannot join
- History of lymphedema secondary to axillary surgery.
- Inability to provide informed consent for participation in the study.
- Prior diagnosis of hearing impairments that hinder or prevent music listening, such as partial or total deafness.
- Prior diagnosis of any central or peripheral neurological condition.
- Presence of comorbidities or conditions that contraindicate participation in a physical exercise program.
- A preliminary screening of participants will be conducted based on the recommendations of the National Comprehensive Cancer Network (NCCN), considering the risk of potential exercise-induced adverse effects.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Center of Physiotherapy and Podiatry, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Spain (Avicena Street, s/n)
Seville, España, 41009
Ana Trigueros, MSc, Physiotherapy, +34605386707, atrigueros1@us.es
María Jesús Casuso, PhD, Physiotherapy, +34659213135, mcasuso@us.es
About this study
This clinical trial aims to compare the effects of a concurrent physical exercise program (aerobic and resistance training) combined with music medicine versus exercise alone on self-perception (self-esteem and body image), physical condition (strength, fatigue, cardiovascular endurance) and general well-being (quality of life and sleep quality) in female breast cancer survivors.
The main research question is:
Read more
- Is a program that combines physical exercise and music therapy more effective than physical exercise alone in improving self-perception, physical condition, and general well-being in breast cancer survivors?
Participants will be randomly assigned to one of two groups:
- One group will receive concurrent physical exercise combined with music therapy.
- The other group will receive the same exercise program without music therapy. Assessments will be conducted at three time points: before the intervention, immediately after the intervention, and 6 months post-intervention.
- Conditions
- Breast Cancer Survivors
- Being tested
- Supervised Station-Based Strength Circuit Training & Self-directed aerobic training, Music Medicine
- Keywords
- Breast cancer survivors, Concurrent exercise, Music medicine, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Station-Based Strength Circuit Training & Self-directed aerobic trainingOther
Anaerobic training sessions follow a circuit design alternating upper body, lower body, and core exercises with dumbbells, barbells, and kettlebells. Participants complete 3 sets of 10-15 repetitions per exercise, performed consecutively without rest, at 60-80% of their one-repetition maximum (1RM). Two participants perform the same exercise simultaneously at each station. Load progression is applied by increasing resistance by 10% after successfully completing 3 sets of 12 repetitions across two consecutive sessions.
Sessions begin with a 5-minute warm-up at 50-65% of maximal heart rate (HRmax), followed by nine resistance exercises: kettlebell squats, static plank, bench press, weighted lunges, quadruped superman, seated row, weighted glute bridge, leg raises, and shoulder press. Exercises alternate muscle groups to optimize recovery.
Additionally, participants engage in self-selected aerobic exercise (walking, running, rowing, swimming, or stationary cycling) twice weekly at 65-80
Music MedicineOther
During the warm-up phase, participants will engage in individual passive music listening, tailored to their personal musical preferences. The music will be delivered via MP3 players or smartphones, where a personalized playlist containing the participant's favorite tracks has been preloaded. Subsequently, during the circuit training session, a group background music playlist will be played through speakers. This heterogeneous playlist is compiled based on the collective musical preferences of all participants. Finally, during the cool-down phase, a common background music selection will be used, featuring a different repertoire from earlier phases. The cool-down will include guided muscle relaxation and breathing exercises assisted by the background music.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Exercise and Music Medicine | Experimental | Supervised Station-Based Strength Circuit Training (2 sessions/week) combined with music medicine. Receives: Other: Supervised Station-Based Strength Circuit Training & Self-directed aerobic training; Other: Music Medicine |
| Concurrent exercise | Active comparator | Supervised Station-Based Strength Circuit Training (2 sessions/week) Receives: Other: Supervised Station-Based Strength Circuit Training & Self-directed aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Self-Esteem Measured by the Rosenberg Self-Esteem Scale (RSES).
The instrument evaluates constructs of self-worth and self-acceptance via 10 items, comprising five positively phrased and five negatively phrased statements, each scored on a 4-point Likert scale (1 = strongly agree, 2 = agree, 3 = disagree, 4 = strongly disagree). Total scores range from 10 to 40 points, with reverse scoring applied to negatively worded items to ensure accurate assessment. Elevated total scores correspond to higher self-esteem levels. The scale exhibits robust internal consistency (Cronbach's alpha = 0.87) and established construct validity
Measured: Self-esteem will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Secondary outcomes (7)
Change from Baseline in Body Image Measured by the Hopwood Body Image Scale (S-BIS).
The S-BIS is a psychometrically validated instrument comprising 10 items that assess multiple dimensions of body image, including affective, cognitive, and behavioral domains. Responses are recorded on a 4-point Likert scale ranging from 0 (not at all) to 3 (very much). Total scores span from 0 to 30, with elevated scores (21-30) indicative of pronounced disturbances in body image perception. The scale exhibits excellent internal consistency reliability (Cronbach's alpha = 0.966).
Measured: Body image will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Change from Baseline in Fatigue Levels Measured by the Piper Fatigue Scale (PFS).
The Piper Fatigue Scale is a 22-item questionnaire scored from 0 to 10 that assesses behavioral, affective, sensory, and cognitive dimensions of fatigue. The maximum score, indicating high levels of fatigue, is 220 points. The instrument demonstrates good internal consistency, with a Cronbach's alpha greater than 0.86. Construct and criterion validity have been established
Measured: Fatigue will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Change from Baseline in Upper Limb Strength Measured by Handgrip Dynamometry.
A handgrip dynamometer will be used to assess grip strength with the patient in a standing position and the elbow flexed at 90°. The test will be performed alternately three times on each hand, with a one-minute rest interval between trials. Higher kilogram values correspond to greater grip strength. This procedure is considered the gold standard for assessing upper limb strength.
Measured: Handgrip strength will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Change from Baseline in Lower Limb Strength Measured by the 5-Repetition Sit-to-Stand Test (5STS).
This is a functional test designed to assess lower limb strength. Participants begin the test seated on an armless chair with a seat height between 41 and 45 cm, with their arms crossed over the chest. They are instructed to stand up and sit down five times consecutively as quickly as possible without using their upper limbs for support. Timing is recorded with a stopwatch, starting at the verbal cue 'go' and stopping when the participant sits after the fifth repetition. Longer completion times may indicate muscle weakness.
Measured: Handgrip strength will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Change from Baseline in Cardiovascular Endurance Measured by the 6-Minute Walk Test (6MWT).
This test evaluates physical and Cardiovascular endurance calculating the maximum distance the participant is able to walk over six minutes on a predefined course set along a flat indoor corridor with two turning points. Longer walking distances reflect superior cardiovascular and functional aerobic capacity. Its reliability and validity in patients with cancer have been demonstrated, with an intraclass correlation coefficient (ICC) of 0.93.
Measured: Cardiovascular endurance will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Change from Baseline in Quality of Life Measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B), Version 4.
This 37-item questionnaire comprises four subscales assessing physical, social/family, emotional, and functional well-being, along with a breast cancer-specific domain. Items are rated on a 5-point Likert scale (0 = not at all; 4 = very much), with a maximum total score of 148 points. Higher scores indicate better quality of life. The instrument demonstrates high overall internal consistency (Cronbach's alpha = 0.90), and its validity and test-retest reliability have been confirmed.
Measured: Quality of Life will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Change from Baseline in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI)
The questionnaire is structured into seven major components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is rated on a scale from 0 (no difficulty) to 3 (severe difficulty), based on patient-reported data. A global score of 0 reflects no sleep difficulties, whereas the maximum score of 21 indicates extreme sleep impairment. The index demonstrates moderate-to-high internal consistency (Cronbach's alpha = 0.81) in clinical populations. Its criterion validity shows a sensitivity of 90% and a kappa index of 0.6.
Measured: Handgrip strength will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study startOct 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blind, parallel assignment. Participants will be equally assigned (1:1) to one of two groups. The experimental group will receive a concurrent exercise program (combining strength and endurance training) enhanced with music medicine. The control group will undergo the same concurrent exercise program without music therapy, serving as an active comparator.The evaluator will remain blinded to the intervention assigned to each participant throughout the study .
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ana Trigueros Murillo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ana Trigueros Murillo, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045961
- Sponsor's protocol ID
- 2025-0855
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Exercise in Combination With Music Listening in Female Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07045961
- Acronym / sponsor ID
- 2025-0855
- Conditions
- Breast Cancer Survivors
- Keywords
- Breast cancer survivors, Concurrent exercise, Music medicine, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ana Trigueros MurilloUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to compare the effects of a concurrent physical exercise program (aerobic and resistance training) combined with music medicine versus exercise alone on self-perception (self-esteem and body image), physical condition (strength, fatigue, cardiovascular endurance) and general well-being (quality of life and sleep quality) in female breast cancer survivors.
The main research question is:
- Is a program that combines physical exercise and music therapy more effective than physical exercise alone in improving self-perception, physical condition, and general well-being in breast cancer survivors?
Participants will be randomly assigned to one of two groups:
- One group will receive concurrent physical exercise combined with music therapy.
- The other group will receive the same exercise program without music therapy. Assessments will be conducted at three time points: before the intervention, immediately after the intervention, and 6 months post-intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single-blind, parallel assignment. Participants will be equally assigned (1:1) to one of two groups. The experimental group will receive a concurrent exercise program (combining strength and endurance training) enhanced with music medicine. The control group will undergo the same concurrent exercise program without music therapy, serving as an active comparator.The evaluator will remain blinded to the intervention assigned to each participant throughout the study .
| Arm | Type | Receives |
|---|---|---|
| Concurrent Exercise and Music Medicine | Experimental | Other: Supervised Station-Based Strength Circuit Training & Self-directed aerobic training, Other: Music MedicineSupervised Station-Based Strength Circuit Training (2 sessions/week) combined with music medicine. |
| Concurrent exercise | Active comparator | Other: Supervised Station-Based Strength Circuit Training & Self-directed aerobic trainingSupervised Station-Based Strength Circuit Training (2 sessions/week) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged between 18 and 75 years with a prior diagnosis of stage 0-III breast cancer.
- Women currently in the survivorship phase of the disease, regardless of the type of medical or surgical treatment received.
- A minimum of six months must have elapsed since the completion of primary treatment.
Key exclusion criteria (6 listed)
- History of lymphedema secondary to axillary surgery.
- Inability to provide informed consent for participation in the study.
- Prior diagnosis of hearing impairments that hinder or prevent music listening, such as partial or total deafness.
- Prior diagnosis of any central or peripheral neurological condition.
- Presence of comorbidities or conditions that contraindicate participation in a physical exercise program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Station-Based Strength Circuit Training & Self-directed aerobic trainingAnaerobic training sessions follow a circuit design alternating upper body, lower body, and core exercises with dumbbells, barbells, and kettlebells. Participants complete 3 sets of 10-15 repetitions per exercise, performed consecutively without rest, at 60-80% of their one-repetition maximum (1RM). Two participants perform the same exercise simultaneously at each station. Load progression is applied by increasing resistance by 10% after successfully completing 3 sets of 12 repetitions across two consecutive sessions. Sessions begin with a 5-minute warm-up at 50-65% of maximal heart rate (HRmax), followed by nine resistance exercises: kettlebell squats, static plank, bench press, weighted lunges, quadruped superman, seated row, weighted glute bridge, leg raises, and shoulder press. Exercises alternate muscle groups to optimize recovery. Additionally, participants engage in self-selected aerobic exercise (walking, running, rowing, swimming, or stationary cycling) twice weekly at 65-80 | Other | Concurrent Exercise and Music Medicine, Concurrent exercise |
| Music MedicineDuring the warm-up phase, participants will engage in individual passive music listening, tailored to their personal musical preferences. The music will be delivered via MP3 players or smartphones, where a personalized playlist containing the participant's favorite tracks has been preloaded. Subsequently, during the circuit training session, a group background music playlist will be played through speakers. This heterogeneous playlist is compiled based on the collective musical preferences of all participants. Finally, during the cool-down phase, a common background music selection will be used, featuring a different repertoire from earlier phases. The cool-down will include guided muscle relaxation and breathing exercises assisted by the background music. | Other | Concurrent Exercise and Music Medicine |
Primary outcome
Change from baseline in Self-Esteem Measured by the Rosenberg Self-Esteem Scale (RSES).
Time frame: Self-esteem will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
The instrument evaluates constructs of self-worth and self-acceptance via 10 items, comprising five positively phrased and five negatively phrased statements, each scored on a 4-point Likert scale (1 = strongly agree, 2 = agree, 3 = disagree, 4 = strongly disagree). Total scores range from 10 to 40 points, with reverse scoring applied to negatively worded items to ensure accurate assessment. Elevated total scores correspond to higher self-esteem levels. The scale exhibits robust internal consistency (Cronbach's alpha = 0.87) and established construct validity
7 secondary outcomes
Change from Baseline in Body Image Measured by the Hopwood Body Image Scale (S-BIS).
Time frame: Body image will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Change from Baseline in Fatigue Levels Measured by the Piper Fatigue Scale (PFS).
Time frame: Fatigue will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Change from Baseline in Upper Limb Strength Measured by Handgrip Dynamometry.
Time frame: Handgrip strength will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Change from Baseline in Lower Limb Strength Measured by the 5-Repetition Sit-to-Stand Test (5STS).
Time frame: Handgrip strength will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Change from Baseline in Cardiovascular Endurance Measured by the 6-Minute Walk Test (6MWT).
Time frame: Cardiovascular endurance will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Change from Baseline in Quality of Life Measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B), Version 4.
Time frame: Quality of Life will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Change from Baseline in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Handgrip strength will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- National Comprehensive Cancer Network (NCCN)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Station-Based Strength Circuit Training & Self-directed aerobic training and Music Medicine in people with Breast Cancer Survivors, run by Ana Trigueros Murillo at 1 site in Spain.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 1 Jul 2025. 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 Spain. 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 Ana Trigueros, MSc. Physiotherapy. (+34605386707, atrigueros1@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Self-Esteem Measured by the Rosenberg Self-Esteem Scale (RSES). (time frame: Self-esteem will be assessed at three time points: prior to the intervention (baseline), immediately following the intervention (post-intervention), and at 6-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2025.