Water and Land-based Aerobic Training in Breast Cancer Survivors (WaterMama)

Federal University of Pelotas

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Other: Aquatic Training Plus Health Education; Other: Land Training Plus Health Education; Other: Health Education

Study type: Interventional

Funder types: Other

Identifiers

NCT05520515

55791222.0.0000.5313

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

Aquatic training plus health education group

Experimental group

Description:

Aerobic exercise training program in the aquatic environment twice a week plus health education program once a week

Treatment:

Other: Aquatic Training Plus Health Education

Land training plus health education group

Experimental group

Description:

Aerobic exercise training program in the land environment twice a week plus health education program once a week

Treatment:

Other: Land Training Plus Health Education

Health education group

Active Comparator group

Description:

Health education program once a week

Treatment:

Other: Health Education