Concurrent Exercise in Combination With Music Listening in Female Breast Cancer Survivors

NCT07045961 | Not Yet Recruiting

• 1 other identifier: 2025-0855
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Breast Cancer Survivors

Keywords

Breast cancer survivors; Concurrent exercise; Music medicine; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  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).

  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.

  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).

  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).

  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.

Study Arms (2)

Concurrent Exercise and Music Medicine

EXPERIMENTAL

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

Concurrent exercise

ACTIVE COMPARATOR

Supervised Station-Based Strength Circuit Training (2 sessions/week)

Other: Supervised Station-Based Strength Circuit Training & Self-directed aerobic training

Interventions

Supervised Station-Based Strength Circuit Training & Self-directed aerobic training OTHER

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

Concurrent Exercise and Music Medicine; Concurrent exercise

Music Medicine OTHER

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.

Concurrent Exercise and Music Medicine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ana Trigueros Murillo: lead

Study Sites (1)

Center of Physiotherapy and Podiatry, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Spain (Avicena Street, s/n)

Seville, España, 41009, Spain

Location

Related Links

• National Comprehensive Cancer Network (NCCN)

Central Study Contacts

Ana Trigueros, MSc. Physiotherapy.

CONTACT

+34605386707; atrigueros1@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc, Physiotherapy

Model Details: 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 .

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

ES (1)