Trial Title:
Water and Land-based Aerobic Training in Breast Cancer Survivors
NCT ID:
NCT05520515
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
physical exercise
breast neoplasm
physical activity
aquatic exercise
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Other
Intervention name:
Aquatic Training Plus Health Education
Description:
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.
Arm group label:
Aquatic training plus health education group
Intervention type:
Other
Intervention name:
Land Training Plus Health Education
Description:
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.
Arm group label:
Land training plus health education group
Intervention type:
Other
Intervention name:
Health Education
Description:
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.
Arm group label:
Health education group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Escola Superior de Educação Física
Address:
City:
Pelotas
Zip:
96055-630
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Cristine L Alberton, PhD
Start date:
December 19, 2022
Completion date:
August 30, 2025
Lead sponsor:
Agency:
Federal University of Pelotas
Agency class:
Other
Source:
Federal University of Pelotas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05520515
