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Spots Global Cancer Trial Database for Effects of a Physical Exercise Program in Quality of Life of Breast Cancer Survivors

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Trial Identification

Brief Title: 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 ID: NCT04024280

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Centro Hospitalar de Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Oporto, Portugal

Contact Details

Name: Ana Joaquim, MD

Affiliation: Centro Hospitalar de Vila Nova de Gaia/Espinho

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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