NCT05520515: WaterMama

Water and Land-based Aerobic Training in Breast Cancer Survivors

Active, enrolled NA Last updated 26 June 2025

What this trial tests

NA trial testing Aquatic Training Plus Health Education in Breast Cancer in 48 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 December 2022

Primary endpoint
30 July 2025

30 August 2025

Quick facts

Lead sponsor	Federal University of Pelotas
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	48
Start date	19 December 2022
Primary completion	30 July 2025
Estimated completion	30 August 2025
Sites	1 location across Brazil

Drugs / interventions tested

• Aquatic Training Plus Health Education
• Land Training Plus Health Education
• Health Education

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Federal University of Pelotas

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Land- and water-based aerobic exercise program on health-related outcomes in breast cancer survivors (WaterMama): study protocol for a randomized clinical trial.
   Alberton CL, Andrade LS, Xavier BEB, Pinheiro VHG, et al · · 2024 · PMID 39138559 · DOI 10.1186/s13063-024-08389-y