Water and Land-based Aerobic Training on Health-related Outcomes in Breast Cancer Survivors: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Cancer-related fatigue
研究概览
简要总结
Background: Breast cancer is the type of cancer that mostly affects women in the world. Although physical and psychological side effects accompany cancer and the aggressiveness of the treatment, regular practice of physical exercise is considered a non-pharmacological tool to improve the quality of life of breast cancer survivors. The present study aims to evaluate the effects of aerobic training programs in aquatic and land environments plus a health education program, compared with a health education program alone, on cancer-related fatigue and other health-related outcomes in breast cancer survivors.
Methods: The WaterMama trial is a randomized, single-blinded, three-arm, parallel, superiority trial. Forty-eight women, ≥18 years of age, who have completed primary treatment and been diagnosed with stage I-III breast cancer are recruited. Participants are randomly allocated on a 1:1:1 ratio to 12-week interventions of aerobic exercise training programs either on the aquatic or land environment two times per week plus health education, or an active-control group receiving health education intervention, once a week. Cancer-related fatigue (primary outcome), physical fitness (i.e., muscle strength of the knee extensors, muscle thickness and muscle quality of quadriceps, resting heart rate, maximum oxygen consumption, and performance in functional tests), mental health (i.e., depressive and anxiety symptoms), cognitive function, pain and quality of life are measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria.
Discussion: The conceptual hypothesis is that both training programs plus health education positively affect cancer-related fatigue, physical fitness, mental health, cognitive function, pain, and quality of life compared to the health education group alone. Additionally, it is expected that the aquatic program plus health education to provide more significant effects on cancer-related fatigue and physical parameters due to its multi-component character, with a consequent greater positive impact on other investigated parameters in this group.
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
- Single (Outcomes Assessor)
盲法说明
Blinding will be implemented for the outcome assessors. All tests and questionnaires will be supervised by an evaluator blinded to the participant's group. Due to the type of intervention, the investigator conducting exercise sessions and participants will not be blinded.
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 diagnosed with stage I-III breast cancer;
- •Aged ≥ 18 years old;
- •Have completed primary treatment for breast cancer (including surgery, chemotherapy, and/or radiotherapy) for at least six months and at most 12 months before the start of the intervention, regardless to be or not on hormonal treatment;
- •Willingness to participate in either intervention group, as well as not to have a fear of the aquatic environment.
排除标准
- •Presence of serious orthopedic, cardiovascular, or cardiopulmonary conditions that limit physical exercise participation;
- •Major psychiatric or cognitive disorders;
- •Active metastatic or locoregional disease;
- •Severe nausea, anorexia, or another condition that makes it impossible to participate in the exercise;
- •Engagement in regular exercise for more than 75 min weekly.
- •Or were otherwise not cleared by their oncologist.
研究组 & 干预措施
Aquatic training plus health education group
Aerobic exercise training program in the aquatic environment twice a week plus health education program once a week
干预措施: Aquatic Training Plus Health Education (Other)
Land training plus health education group
Aerobic exercise training program in the land environment twice a week plus health education program once a week
干预措施: Land Training Plus Health Education (Other)
Health education group
Health education program once a week
干预措施: Health Education (Other)
结局指标
主要结局
Cancer-related fatigue
时间窗: Baseline (week 0) to post-training (week 13)
Cancer-related fatigue is measured with the Portuguese Piper Fatigue Scale (PFS) version. The Brazilian version of the PFS is a valid and reliable instrument for assessing fatigue in cancer patients in Brazil (Mota et al., 2009). The PFS consists of 22 numerical items assessing fatigue experienced by the patients (Piper et al., 1998), using a 0-10 numeric scale. The PFS measures four dimensions of subjective fatigue are: behavioral/severity, affective meaning, sensory, and cognitive/mood. The total fatigue score is calculated by adding the four subscale scores and dividing this sum by four.
次要结局
- Functional tests - 8-ft Up and Go Test(Baseline (week 0) to post-training (week 13))
- Functional tests - Back Scratch Test(Baseline (week 0) to post-training (week 13))
- Muscle thickness(Baseline (week 0) to post-training (week 13))
- Muscle quality(Baseline (week 0) to post-training (week 13))
- Cardiorespiratory fitness(Baseline (week 0) to post-training (week 13))
- Dynamic muscular endurance(Baseline (week 0) to post-training (week 13))
- Functional tests - Chair Sit-and-Reach Test(Baseline (week 0) to post-training (week 13))
- Maximal dynamic strength(Baseline (week 0) to post-training (week 13))
- Functional tests - Arm Curl Test(Baseline (week 0) to post-training (week 13))
- Functional tests - 30-s Chair Stand Test(Baseline (week 0) to post-training (week 13))
- Functional tests - 6-min Walk Test(Baseline (week 0) to post-training (week 13))
- Depressive and anxiety symptoms is measured using the Hospital Anxiety and Depression Scale (HADS).(Baseline (week 0) to post-training (week 13))
- Pain is characterized by the short version of the Brief Pain Inventory (BPI-B).(Baseline (week 0) to post-training (week 13))
- Quality of life is measured using the Functional Assessment of Cancer Therapy-Breast questionnaire (FACT-B).(Baseline (week 0) to post-training (week 13))
- Perceived cognitive function(Baseline (week 0) to post-training (week 13))
- Objective cognitive function - Trail Making Test (TMT)(Baseline (week 0) to post-training (week 13))
- Objective cognitive function - Controlled Oral Word Association Test (COWAT)(Baseline (week 0) to post-training (week 13))
研究者
Cristine Lima Alberton
Principal Investigator
Federal University of Pelotas