Breast Neoplasms Medical Oncology
Conditions
Interventions
This is a randomized, controlled clinical trial with four parallel arms and no blinding. After signing the Informed Consent Form, eligible participants will be randomly allocated into four groups, wit
s functional capacity, and breathing and stretching exercises for relaxation. The Resistance Exercise protocol will include stretching warm-up exercises, upper and lower limb strengthening exercises u
Sponsors
Fundação Universidade do Estado de Santa Catarina (UDESC)
Cancer Research Center (CEPON), Santa Catarina State Health Secretariat
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women aged 18 years or older; diagnosed with primary breast cancer; who have undergone at least one type of treatment (surgery, chemotherapy, radiotherapy and/or hormone therapy), completed at least one year before study enrollment, except for participants receiving hormone therapy; and physically inactive, defined as not meeting the World Health Organization recommendation of at least 150 minutes of physical activity per week.
Exclusion criteria
Exclusion criteria: Participants with tumor recurrence or distant metastasis diagnosed after the beginning of treatment, those who have undergone recent surgical procedures, or those presenting any physical or cognitive condition preventing participation in the study procedures will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Different exercise modalities are expected to improve the physical and psychological health of breast cancer survivors. Outcomes will be assessed using the Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), Perceived Stress Scale (PSS), Brunel Mood Scale (BRUMS), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale, Body Image Scale (BIS), Disabilities of the Arm, Shoulder and Hand (DASH), Numerical Pain Rating Scale and Functional Assessment of Cancer Therapy–Breast (FACT-B+4), comparing baseline, one week, eight weeks and four-week follow-up assessments. Reductions in anxiety, depression, stress, daytime sleepiness and pain, together with improvements in mood, sleep quality, body image, upper-limb function and quality of life are expected.;Observed outcome 1: Exercise interventions improved important physical and psychological outcomes, assessed using the BAI, BDI, PSQI, Epworth Sleepiness Scale, DASH, Numerical Pain Rating Scale and FACT-B+4. In the pooled exercise group (n=23), significant reductions were observed for anxiety (p=0.004), depression (p=0.003), pain (p<0.001) and daytime sleepiness (p=0.008), together with improvements in sleep quality (p=0.001) and quality of life (p=0.029). No statistically significant differences were observed between the exercise and control groups or among Pilates, Yoga and Resistance Exercise. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: To characterize the sociodemographic and clinical profile of breast cancer survivors using demographic, anthropometric and clinical data collected at baseline. Age, educational level, monthly income, type of surgery, lymph node removal, breast reconstruction and postoperative time will be described.;Observed outcome 2: Thirty-one participants were characterized (Pilates=9, Yoga=8, Resistance Exercise=6 and Control=8). No significant differences were observed among groups regarding age, body weight, height, monthly income, postoperative time, educational level, type of surgery, lymph node removal or breast reconstruction (p>0.05), demonstrating comparable baseline characteristics.;Expected outcome 3: To evaluate the acute and longitudinal effects of different exercise modalities on physical and psychological outcomes using repeated assessments at baseline, one week, eight weeks and four-week follow-up.;Observed outcome 3: Physical and psychological outcomes were evaluated using the BAI, BDI, PSQI, Epworth Sleepiness Scale, DASH, Numerical Pain Rating Scale and FACT-B+4. Significant improvements were observed in anxiety (p=0.004), depression (p=0.003), sleep quality (p=0.001), daytime sleepiness (p=0.008), pain (p<0.001) and quality of life (p=0.029) throughout follow-up.;Expected outcome 4: To compare the effects of Pilates, Yoga and Resistance Exercise with the Control Group using physical and psychological assessments performed throughout the study.;Observed outcome 4: Comparisons among Pilates, Yoga, Resistance Exercise and Control were performed using non-parametric analyses. No statistically significant differences were observed among interventions for most outcomes. Depression showed a significant difference at post-intervention (p=0.038); however, this finding was no longer significant after Bonferroni correction.;Expected outcome 5: To evaluate adherence to the exercise program using the Exercise Adherence Rating Scale (EARS-Br), exp | — |
Countries
BR
Contacts
Public ContactKeyla dos Santos
Universidade do Estado de Santa Catarina
Outcome results
None listed