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

NCT ID: NCT07045961

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Concurrent Exercise and Music Medicine

Supervised Station-Based Strength Circuit Training (2 sessions/week) combined with music medicine.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Music Medicine

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Music Medicine

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ana Trigueros Murillo

OTHER

Sponsor Role: lead

Responsible Party

Ana Trigueros Murillo

MSc, Physiotherapy

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Seville, España, Spain

Countries

Spain

Central Contacts

Ana Trigueros, MSc. Physiotherapy.

Role: CONTACT

atrigueros1@us.es

+34605386707

Facility Contacts

Ana Trigueros, MSc, Physiotherapy

Role: primary

atrigueros1@us.es

+34605386707

María Jesús Casuso, PhD, Physiotherapy

Role: backup

mcasuso@us.es

+34659213135

Related Links

https://bmtinfonet.org/es/resource/red-nacional-integral-del-cancer-national-comprehensive-cancer-network

National Comprehensive Cancer Network (NCCN)

Other Identifiers

2025-0855

Identifier Type: -

Identifier Source: org_study_id