Clinical trial NCT05520515: Water and Land-based Aerobic Training in Breast Cancer Survivors
Official title: Water and Land-based Aerobic Training on Health-related Outcomes in Breast Cancer Survivors: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: physical exercise
breast neoplasm
physical activity
aquatic exercise
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.


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.

Primary outcomes:
measure: Cancer-related fatigue
timeFrame: Baseline (week 0) to post-training (week 13)
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Maximal dynamic strength
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Dynamic muscular endurance
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Functional tests - Arm Curl Test
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Functional tests - 30-s Chair Stand Test
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Functional tests - 8-ft Up and Go Test
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Functional tests - Chair Sit-and-Reach Test
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Functional tests - Back Scratch Test
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Functional tests - 6-min Walk Test
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Muscle thickness
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Muscle quality
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Depressive and anxiety symptoms is measured using the Hospital Anxiety and Depression Scale (HADS).
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Perceived cognitive function
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Objective cognitive function - Trail Making Test (TMT)
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Objective cognitive function - Controlled Oral Word Association Test (COWAT)
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Pain is characterized by the short version of the Brief Pain Inventory (BPI-B).
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Quality of life is measured using the Functional Assessment of Cancer Therapy-Breast questionnaire (FACT-B).
timeFrame: Baseline (week 0) to post-training (week 13)
Other outcomes:
measure: Body mass
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Height
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Body mass index
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Waist and hip circumferences
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Physical activity levels
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Food consumption
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Office Blood Pressure
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Sociodemographic and clinical characteristics
timeFrame: Baseline (week 0)
measure: Follow-up questionnaire
timeFrame: Post-training (week 13)
measure: Adherence assessments
timeFrame: Post-training (week 13)
Locations:
city: Pelotas
country: Brazil
facility: Escola Superior de Educação Física
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Cristine L Alberton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Pelotas
name: Stephanie S Pinto, PhD
role: STUDY_DIRECTOR
References: