An interventional study of Supervised Station-Based Strength Circuit Training & Self-directed aerobic training and Music Medicine in Breast Cancer Survivors, sponsored by Ana Trigueros Murillo. Not yet recruiting at 1 site in Spain. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Ana Trigueros Murillo · Not applicable, Interventional, and Supportive care
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:
This is the only study on the registry with Ana Trigueros Murillo as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Presence of comorbidities or conditions that contraindicate participation in a physical exercise program.
Supervised Station-Based Strength Circuit Training (2 sessions/week) combined with music medicine.
Other: Supervised Station-Based Strength Circuit Training & Self-directed aerobic training · Other: Music Medicine
Supervised Station-Based Strength Circuit Training (2 sessions/week)
Other: Supervised Station-Based Strength Circuit Training & Self-directed aerobic training
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
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.
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
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.
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).
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).
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
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.
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.
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).
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.
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).
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.
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.
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.
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)
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.
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.
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