Concurrent Exercise in Combination With Music Listening in Female Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change from baseline in Self-Esteem Measured by the Rosenberg Self-Esteem Scale (RSES).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Concurrent Exercise and Music Medicine
Supervised Station-Based Strength Circuit Training (2 sessions/week) combined with music medicine.
干预措施: Supervised Station-Based Strength Circuit Training & Self-directed aerobic training (Other)
Concurrent Exercise and Music Medicine
Supervised Station-Based Strength Circuit Training (2 sessions/week) combined with music medicine.
干预措施: Music Medicine (Other)
Concurrent exercise
Supervised Station-Based Strength Circuit Training (2 sessions/week)
干预措施: Supervised Station-Based Strength Circuit Training & Self-directed aerobic training (Other)
结局指标
主要结局
Change from baseline in Self-Esteem Measured by the Rosenberg Self-Esteem Scale (RSES).
时间窗: 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.
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 Self-Esteem Measured by the Rosenberg Self-Esteem Scale (RSES).
时间窗: 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.
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
次要结局
- 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 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.)
- Change from Baseline in Quality of Life Measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B), Version 4.(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)(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 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 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.)
- Change from Baseline in Quality of Life Measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B), Version 4.(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)(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.)
研究者
Ana Trigueros Murillo
MSc, Physiotherapy
University of Seville