Clinical trial NCT04024280: Effects of a Physical Exercise Program in Quality of Life of Breast Cancer Survivors
Official title: Effects of a Physical Exercise Program in Quality of Life of Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Quality of Life
Physical Exercise
Lead sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar de Vila Nova de Gaia/Espinho
name: Aveiro University
name: University Institute of Maia
First posted: 2019-07-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: A 16 weeks 3-weekly supervised and adapted physical exercise program will be applied to breast cancer survivors in surveillance and, in estrogen receptor positive cases, under hormonotherapy. The program will be applied in group classes of 20 participants, in the facilities of one local gymnasium, by fitness instructors included in the investigation team. Investigators will evaluate the Health-Related Quality of Life (HRQoL), physical activity, cardiopulmonary fitness, upper limb strength and lower limb functionality. The investigators also aim to evaluate the safety of the program and oncological outcomes such as symptoms related to disease and its treatment and, also, overall survival and disease free survival.

Detailed description: This protocol describes a two-arm prospective non randomized trial that will test the HRQoL effect of a 16 weeks 3-weekly supervised and adapted physical exercise program that combines muscle strength and aerobic training with progressive intensity. The benefits of physical exercise programs in breast cancer survivors is well known. However, the studied programs usually are not generalizable because of needs of specialized exercise professionals and materials. The investigators aim to evaluate if it is possible to obtain the same benefits in HRQoL, physical activity, cardiopulmonary fitness, upper limb strength and lower limb functionality when the program is applied in group classes by trained fitness instructors with exercise strategies based in limited material. Maximum participants of each group class is 20. Each participant will pass through a 16 weeks control phase, during which should maintain the usual physical activity and, then, through a 16 weeks study phase, during which undergoes the physical exercise program. In each phase, the participants will be serially evaluated. During the 32 weeks, each participant will pass through 5 evaluation moments: at baseline, at 8 weeks, at 16 weeks before beginning the study phase, at 8 weeks of physical exercise and 16 weeks of physical exercise at the end of the program. After, investigators aim to evaluate each participant at 3, 6 and 12 months ant, then, yearly.

Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of breast carcinoma
* Stages 0 to IIIC
* Having undergo primary treatment with curative intent, defined as surgery that can have been complemented with neoadjuvant, or adjuvant, chemotherapy and/or radiotherapy
* Conclusion of the last of the following treatments at least one month before: surgery, chemotherapy or radiotherapy
* At least one consultation in the Medical Oncology Department of the Centro Hospitalar de Vila Nova de Gaia/Espinho
* Assistant medical oncologist consent for the physical exercise practice
* Not meeting the physical activity guidelines of the American College of Sports Medicine (moderate activity ≥ 150 minutes/week ou vigorous activity ≥ 75 minutes/week and ≥ 2 resistance training/week).

Exclusion Criteria:

* Severe anemia (Hb ≤ 8 g/dL)
* Symptomatic moderate anemia (Hb \>8 and ≤ 10 g/dL); considered symptoms are: sustained tachycardia, exertion dyspnea, thoracic pain or syncope
* Uncontrolled hypertension
* Uncontrolled diabetes
* Cardiac failure grade \>1 in the New York Heart Association evaluation
* History of osteoporosis with Tscore \<-2.5 in the lumbar spine and/or femur in the menopause
* Contraindication given by the assistant surgeon

Primary outcomes:
measure: Health Related Quality of Life
timeFrame: Baseline
measure: Health Related Quality of Life
timeFrame: Week 8
measure: Health Related Quality of Life
timeFrame: Week 16
measure: Health Related Quality of Life
timeFrame: Week 24
measure: Health Related Quality of Life
timeFrame: Week 32
Secondary outcomes:
Other outcomes:
Locations:
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho
state: Oporto
Study officials:
affiliation: Centro Hospitalar de Vila Nova de Gaia/Espinho
name: Ana Joaquim, MD
role: PRINCIPAL_INVESTIGATOR
References: