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.
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.
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.
Parallel
Supervised Station-Based Strength Circuit Training & Self-directed aerobic training
Other interventionAnaerobic 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 Medicine
Other interventionDuring 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
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).
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
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.
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.
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Ana Trigueros Murillo
Lead sponsor
University of Seville
Sponsor institution
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