Therapeutic Plyometric-Based Strength-Endurance Exercise Program for Breast Cancer Patients and Survivors to Improve Quality of Life and Physical and Mental Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Quality of life (Breast Cancer-Specific Quality of Life)
研究概览
简要总结
This study aims to compare an adapted plyometric strength-endurance exercise program with conventional strength training in women who are breast cancer survivors or currently undergoing treatment and who participate in provincial support associations. The goal is to determine whether a targeted plyometric intervention can provide additional benefits in physical and mental health outcomes.
Using a cluster-randomized clinical trial design, the study will assess indicators such as functional capacity, muscle strength, fatigue levels, symptoms related to lymphedema, and overall quality of life. The findings are expected to contribute to a better understanding of how structured exercise programs can support recovery, physical function, and well-being in women affected by breast cancer.
详细描述
Breast cancer is the most common malignancy among women worldwide. Despite significant advances in diagnosis and treatment that have improved survival rates, many patients and survivors continue to experience physical and psychological impairments that negatively affect their quality of life. Historically, intense or repetitive upper-limb exercise was discouraged due to concerns about triggering or worsening lymphedema. However, current evidence supports supervised therapeutic exercise as both safe and effective for this population. Strength training, in particular, has demonstrated benefits in muscle mass, physical function, bone health, fatigue reduction, and emotional well-being.
Most existing research has focused on conventional strength training programs, leaving a gap in the evidence regarding more dynamic approaches, such as strength-endurance training involving plyometric exercises. Research on plyometrics within oncology remains limited and has been conducted primarily in pediatric populations, such as survivors of childhood leukemia or children with neurofibromatosis type 1. Nevertheless, plyometric training-traditionally used in athletic performance and in patients with neurological or musculoskeletal conditions-may offer significant therapeutic potential for women living with or recovering from breast cancer.
Plyometric exercises are known to enhance muscular power, balance, proprioception, and neuromuscular control, all of which are essential for restoring functional capacity and independence. Their dynamic, progressive nature may also support greater motivation and adherence, potentially translating into improvements in mental health, self-esteem, and body image.
In summary, plyometric-based strength-endurance training represents an innovative and promising approach to improving quality of life, functional performance, and overall well-being in women who are survivors of breast cancer or currently undergoing treatment. This study aims to address the existing evidence gap by evaluating the therapeutic effects of an adapted plyometric program compared with conventional strength training within a controlled clinical trial framework.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years or older.
- •Prior diagnosis of breast cancer.
- •History of mastectomy, including unilateral procedures, total breast surgery, or breast-conserving surgery.
- •Completion of postoperative chemotherapy or radiotherapy, when indicated.
- •Absence of contraindications for physiotherapy or therapeutic exercise.
- •Willingness to voluntarily participate in the study.
- •Ability to understand and sign the informed consent form.
- •Availability to participate in the training program for the entire intervention period (approximately 12 weeks).
排除标准
- •Participants will be excluded if any of the following conditions are present:
- •Active metastasis to other organs or tissues (e.g., liver, kidney, lung, brain) or stage IV cancer that prevents safe participation in the therapeutic exercise program.
- •Current diagnosis of cardiovascular, respiratory, neuromuscular, or musculoskeletal diseases that contraindicate physical exercise or impair safe completion of the program.
- •Major surgery within the previous 6 months without medical clearance to resume physical activity.
- •Cognitive impairment or mental health conditions that limit comprehension of instructions or safe engagement in the intervention.
- •Current pregnancy.
- •Lack of medical clearance for moderate-to-vigorous physical activity (as indicated by a medical certificate specifying the duration of the restriction and the conditions under which exercise may be resumed).
研究组 & 干预措施
Plyometric Strength-Endurance Training Program
Participants in the experimental group will take part in an adapted plyometric strength-endurance training program delivered through supervised 60-minute sessions, twice per week, over a 12-week period (24 sessions total). A minimum rest interval of 48 hours will be maintained between sessions. The frequency and duration of the intervention follow the recommendations of the National Strength and Conditioning Association (NSCA) for the safe implementation of plyometric and strength-endurance exercise in adult populations.
A total battery of 22 plyometric exercises has been designed based on previous scientific literature in which plyometric movements were adapted for individuals with various clinical conditions. These exercises are progressively structured to ensure safe neuromuscular adaptation, gradual increases in intensity, and individualized progression according to each participant's tolerance and functional capabilities.
干预措施: Plyometric Strength-Endurance Training (Other)
Conventional Strength Training
Participants assigned to the control group will perform a conventional strength training program. This program has been designed as an active and structured intervention to allow a meaningful comparison with the effects of the plyometric training implemented in the experimental group. The exercise circuit will include functional movements aimed at global strengthening, with an emphasis on multi-joint patterns that promote transfer of improvements to activities of daily living. The program will be organized as a circuit of strength exercises performed after the warm-up phase and before the cool-down phase, delivered over a 12-week period through supervised 60-minute sessions held twice per week with at least 48 hours of rest between sessions to allow for adequate muscular recovery. Training volume will progress from 1-3 sets of 8 repetitions in weeks 1-2, increasing to 12-14 reps, and up to 4 sets in the final week based on tolerance.
干预措施: Conventional Strength Training (Other)
结局指标
主要结局
Quality of life (Breast Cancer-Specific Quality of Life)
时间窗: From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period
EORTC QLQ-BR42: European Organisation for Research and Treatment of Cancer (EORTC) to assess breast cancer-specific quality of life. Description: The EORTC QLQ-BR42 is a validated 42-item questionnaire designed to assess breast cancer-specific quality of life. It evaluates physical, emotional, and functional well-being, as well as symptoms and treatment-related side effects relevant to contemporary breast cancer therapies. The measure covers domains such as body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. Scoring: Items are scored according to the EORTC scoring manual. Scores are linearly transformed to a 0-100 scale. Higher scores on functional scales indicate better functioning; higher scores on symptom scales indicate greater symptom burden.
次要结局
- Proprioception(From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period)
- Kinesiophobia(From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period)
- Cardiorespiratory capacity(From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period)
- Intervention acceptability(To the end of treatment at 12 weeks)
- Cancer-related fatigue(From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period)
- Mobility and range of motion(From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period)
- Muscle strength(From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period)
- Upper limb functionality(From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period)
- Presence of lymphedema(From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period)
- Sleep quality(From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period)
- Enjoyment of physical activity(From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period)
- Exercise adherence rate(From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period)
- Satisfaction with the intervention(To the end of treatment at 12 weeks)
- Adverse events(To the end of treatment at 12 weeks)
- Back pain(From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period)
- Pelvic Floor distress(From enrollment to the end of treatment at 12 weeks, followed by an additional 12-week follow-up period)
研究者
Yoana González González
Clinical researcher, PhD
University of Vigo