Effect of Remotely Supervised Combined Aerobic and Resistance Exercise Training on Physical Health and Quality of Life in Women With Breast Cancer During Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in cardiorespiratory functioning, assessed by incremental test according to the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI) Treadmill protocol
研究概览
简要总结
The RE-CARE project is designed to evaluate the effects of a 24-week, remotely supervised, combined high-intensity interval aerobic and resistance exercise training on physical health and quality of life in patients with breast cancer (BC) undergoing neoadjuvant chemotherapy (NACT). The study will enroll women aged 30-65 years with previously untreated, primary breast cancer, clinical stage IIA-IIB or IIIA-IIIC, who are scheduled to receive doxorubicin/cyclophosphamide-based NACT. Participants will be randomly allocated to either an experimental intervention group or a control group. At baseline, comprehensive assessments will be conducted to evaluate cardiorespiratory fitness, physical endurance, muscle strength, cognitive function, and health-related quality of life. The primary objective is to determine the impact of the remotely supervised combined aerobic and resistance exercise on incidence and severity of NACT-related adverse effects in patients with BC.
详细描述
Participants in the RE-CARE intervention group will be scheduled for 2-3 training sessions per week on non-consecutive days throughout the entire chemotherapy period (~24 weeks), ensuring no more than 48 hours elapse between two sessions. Each participant will first complete a 30-40 minute individualized introductory session to learn correct exercise techniques using the training equipment.
Each aerobic high intensity interval training session will begin with a 6-minute warm-up at a self-selected walking speed gradually increasing to moderate intensity (approximately 60-70% HRmax), corresponding to 4 on the Modified Borg scale (moderate perceived exertion) by the end of the warm-up. Following this, the main segment will consist of four 4-minute walking intervals at 85-95% HRmax (7-8 on the Modified Borg scale). Each 4-minute high-intensity interval will be interspersed with 3 minutes of active recovery at 55-70% HRmax (4 on the Modified Borg scale). The total duration of session will therefore be 34 minutes.
For resistance training, participants will perform 3-4 sets of 6 repetitions, with a 2-minute rest interval between sets. The initial workload will be set at 70% of the participant's estimated one-repetition maximum (1RM), corresponding to 6-7 on the Modified Borg scale, and will be increased to 80% (7-8 on the Modified Borg scale) once participants are able to complete more than 6 repetitions. The RT program will target major muscle groups of the legs, shoulders, and arms. Each RT session will last 35 minutes in total, including a 6-minute warm-up and a 3-minute cool-down.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •previously untreated primary breast cancer;
- •stage IIA-B, IIIA-C at diagnosis;
- •diagnosis established by core needle biopsy;
- •age 30-65 years;
- •prescribed doxorubicin/cyclophosphamide-based NACT.
排除标准
- •cardiac pathologies (assessed by echocardiogram);
- •blood transfusion in the last six months;
- •another oncological disease;
- •previous chemotherapy, hormonal or X-ray treatment;
- •participation in another clinical trial.
结局指标
主要结局
Change in cardiorespiratory functioning, assessed by incremental test according to the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI) Treadmill protocol
时间窗: From baseline to 6 months after the intervention
The UNCCRI Treadmill Protocol includes twenty-one 1-minute stages, with systematic increments in treadmill speed and/or grade at each stage. Outcome measures will include maximal oxygen uptake (max ml/kg/min) and ventilatory variables such as minute ventilation (L/min) and respiratory exchange ratio (RER). Heart rate (beats/min) will be continuously monitored throughout each test using a heart rate monitor. Time to exhaustion, treadmill speed, and treadmill grade will be recorded at the point of test termination. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models.
Change in Health-Related Quality of Life, assessed by European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire-Core 30 (EORTC QLQ-C30)
时间窗: From baseline to 6 months after the intervention
Participants will be asked to complete the EORTC QLQ-C30, a 30-item questionnaire, electronically. This instrument includes a global health status/quality-of-life scale and multiple functional subscales (physical, emotional, cognitive, social, and role functioning). It further incorporates several symptom subscales assessing fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Patients respond to the items using Likert scale (1 = "Not at all," 2 = "A little," 3 = "Quite a bit," and 4 = "Very much"). All scales and single-item measures yield scores ranging from 0 to 100%. For the functional scales, higher scores indicate better functioning, but for the symptom scales, higher scores reflect greater symptom severity. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models.
Change in Health-Related Quality of Life, assessed by European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire - Breast Specific module EORTC QLQ-BR23.
时间窗: From baseline to 6 months after the intervention
In addition, participants will complete the EORTC QLQ-BR23, a 23-item, breast cancer-specific questionnaire that includes functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and symptom scales (systemic therapy side effects, breast symptoms, arm symptoms). Patients respond to the items using Likert scale (1 = "Not at all," 2 = "A little," 3 = "Quite a bit," and 4 = "Very much"). All scales and single-item measures yield scores ranging from 0 to 100%. Data obtained will be analyzed using repeated-measures analysis and linear mixed-effects models.
次要结局
- Change in body composition assessed by Body Height (m)(From baseline to 6 months after the intervention)
- Change in body composition assessed by Body Weight (kg)(From baseline to 6 months after the intervention)
- Change in body composition assessed by Body Mass Index (BMI)(From baseline to 6 months after the intervention)
- Change in physical functioning, assessed by 6 Minute Walk tests (6MWT)(From baseline to 6 months after the intervention)
- Change in lower limb strength, assessed by 30 second sit to stand (30STS)(From baseline to 6 months after the intervention)
- Change in lower limb strength, assessed by 5x sit to stand (5xSTS)(From baseline to 6 months after the interventio)
- Change in upper limb strength, assessed by handgrip dynamometer(From baseline to 6 months after the intervention)
- Change in cognitive functioning, assessed by Digit Span test(From baseline to 6 months after the intervention)
- Change in cognitive functioning, assessed by Stroop test(From baseline to 6 months after the intervention)
- Change in cognitive functioning, assessed by The Wisconsin Card Sorting Test(From baseline to 6 months after the intervention)
- Change in Health-Related Quality of Life, assessed by Weekly Health Monitoring(From baseline to 6 months after the intervention)
研究者
Aija Klavina
Dr. Aija Klavina, principal investigator, lead researcher at the Laboratory of Sports and nutrition research (RSU) and professor at the Lithuanian Sport University, Department of Rehabilitation and Health promotion.
Riga Stradins University