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

Обзор

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.

Вмешательства

• Другое 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 tw
• Другое 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 al

Первичные конечные точки

• Change from baseline in Self-Esteem Measured by the Rosenberg Self-Esteem Scale (RSES). [Срок оценки: 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.]

Вторичные конечные точки (7)

• Change from Baseline in Body Image Measured by the Hopwood Body Image Scale (S-BIS). [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: 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) [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Center of Physiotherapy and Podiatry, Faculty of Nursing, Physiotherapy and Podiatry, Univ — Seville

Идентификаторы

NCT: NCT07045961 · 2025-0855

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗