Water and Land-based Aerobic Training in Breast Cancer Survivors

NCT05520515 | Active Not Recruiting

• 1 other identifier: 55791222.0.0000.5313
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

physical exercise; breast neoplasm; physical activity; aquatic exercise

Outcome Measures

Primary Outcomes (1)

• Cancer-related fatigue

  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.

  Baseline (week 0) to post-training (week 13)

Secondary Outcomes (17)

• Cardiorespiratory fitness

  Baseline (week 0) to post-training (week 13)

• Maximal dynamic strength

  Baseline (week 0) to post-training (week 13)

• Dynamic muscular endurance

  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)

Other Outcomes (10)

• Body mass

  Baseline (week 0) to post-training (week 13)

• Height

  Baseline (week 0) to post-training (week 13)

• Body mass index

  Baseline (week 0) to post-training (week 13)

Study Arms (3)

Aquatic training plus health education group

EXPERIMENTAL

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

Other: Aquatic Training Plus Health Education

Land training plus health education group

EXPERIMENTAL

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

Other: Land Training Plus Health Education

Health education group

ACTIVE COMPARATOR

Health education program once a week

Other: Health Education

Interventions

Aquatic Training Plus Health Education OTHER

Participants perform a 12-week training program with two weekly exercise sessions on non-consecutive days. Sessions last 45 min (5 min of warm-up, 35 min of exercise, and 5 min of stretching) throughout the intervention period. The intervention is performed at the thermal pool sector of Clube Brilhante in Pelotas city. The pool water temperature is maintained between 30-32°C, with participants immersed in the depth level between the xiphoid process and shoulders. The aquatic training group performs the following water aerobics exercises: stationary running, frontal kick, cross-country skiing, and butt kick during the stimulus and jumping jacks during the active recovery. The training session is collective, with 3 to 6 participants, supervised by two experienced instructors, one outside and one inside the pool. The group also receives the booklet and the offer of weekly meetings of an educational program (30 min before one of the training sessions) with the same interactive lectures.

Aquatic training plus health education group

Land Training Plus Health Education OTHER

Participants perform a 12-week training program with two weekly exercise sessions on non-consecutive days. Sessions last 45 min (5 min of warm-up, 35 min of exercise, and 5 min of stretching) throughout the intervention period. The intervention occurs at the School of Physical Education, Federal University of Pelotas. Depending on weather conditions, the land training group will perform aerobic training with walking/running exercises in a flat outdoor environment or inside a multi-sport gym. The training session will be collective, with 3 to 6 participants, supervised by two experienced instructors, one at the starting point and the other following the movement of the participants. In addition, the group receives the booklet and the offer of weekly meetings of an educational program (30 min before one of the training sessions) with the same interactive lectures.

Land training plus health education group

Health Education OTHER

The intervention occurs at the School of Physical Education, Federal University of Pelotas. The intervention consists of an educational program with weekly lectures of approximately 30 min. The lectures are led by a qualified health professional, using expository and interactive approaches on topics that cover basic knowledge related to breast cancer and complementary therapies. Additionally, each participant receives a self-care booklet containing information about the topics addressed during the meetings. Qualified professionals give lectures on the following topics: 1) fatigue and quality of life; 2) anxiety and depressive symptoms; 3) body image and sexual function; 4) self-esteem; 5) self-care; 6) sleep; 7) cognitive function; 8) symptoms in the arm and breast; 9) pain and arthralgia; 10) body composition and bone health; 11) eating habits; 12) physical activity.

Health education group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Escola Superior de Educação Física

Pelotas, Rio Grande do Sul, 96055-630, Brazil

Location

Related Publications (1)

• Alberton CL, Andrade LS, Xavier BEB, Pinheiro VHG, Cuesta-Vargas AI, Pinto SS. Land- and water-based aerobic exercise program on health-related outcomes in breast cancer survivors (WaterMama): study protocol for a randomized clinical trial. Trials. 2024 Aug 13;25(1):536. doi: 10.1186/s13063-024-08389-y.

  PMID: 39138559 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Cristine L Alberton, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

• Stephanie S Pinto, PhD

  Federal University of Pelotas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 30, 2022
• Study Start: December 19, 2022
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)