Abstract
Background: Most cancer patients, under active treatment or not, are sedentary, despite increasing scientific and clinical understanding of the benefits of exercise and physical activity, such as improving quality of life, limiting disease symptoms, decreasing cancer recurrence, and increasing overall survival. Studies have shown that both supervised exercise and unsupervised physical activity programs have low adherence and limited long-term benefits among cancer survivors. Therefore, interventions focused on increasing physical activity levels have clinical and psychological relevance. The present study will examine the feasibility and efficacy of an intervention that combines supervised group exercise with active lifestyle recommendations, analyzing its clinical, psychological, physiological, functional, and immunological effects in breast cancer survivors. Methods: Women aged 35–75 years who have completed chemotherapy, radiotherapy, and surgery for breast cancer will be recruited from the Cancer Institute of the State of Sao Paulo (ICESP) and take part in a 16-week, parallel-group, randomized, and controlled trial. They will receive a booklet with recommendations for achieving a physically active lifestyle by increasing overall daily movement and undertaking at least 150 min/week of structured exercise. Then, they will be randomized into two groups: the supervised group will take part in two canoeing group exercise sessions every week, and the unsupervised group will increase their overall physical activity level by any means, such as active commuting, daily activities, or home-based exercise. Primary outcome includes aerobic capacity. Secondary outcomes are physical activity, physical functioning, self-reported quality of life, fatigue, presence of lymphedema, body composition, immune function, adherence to physical activity guidelines, and perceptions of self-image. Discussion: Results should contribute to advance knowledge on the impact of a supervised group exercise intervention to improve aspects related to health, physical functioning, and quality of life in female breast cancer survivors. Trial registration: Brazilian Registry of Clinical Trials Number: RBR-3fw9xf. Retrospectively Registered on 27 December 2018. Items from the World Health Organization Trial Registration Data Set can be accessed on http://www.ensaiosclinicos.gov.br/rg/RBR-3fw9xf/.
Original language | English |
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Article number | 934 |
Journal | Trials |
Volume | 22 |
Issue number | 1 |
DOIs | |
Publication status | Published - 18 Dec 2021 |
Bibliographical note
Funding Information:Principal Investigator and Research Physician?PCB; Design and conduct?LARC, RB, CLMF, CU, GCJ, CMMB, PCB; Preparation of protocol and revisions?LARC, RB, CLMF, CU, GCJ, CMMB, PCB; Organizing steering committee meetings?PCB; Managing CTO [Clinical Trials Office]?PCB; Publication of study reports?LARC, RB, SMML, ARBG, GTS, VAV, GCJ, SAMF, JET, CK, LMN, CU, JCF, CLMF, CMMB, PCB; Members of TMC [Trial Management Committee]?LARC, RB, CLMF, CU, GCJ, CMMB, PCB. Steering Committee - Agreement of final protocol?LARC, RB, SMML, ARBG, GTS, VAV, GCJ, SAMF, JET, CK, LMN, CU, JCF, CLMF, CMMB, PCB; Recruitment of patients and liaising with principle [sic] investigator?RB, LARC, SMML, ARBG; Reviewing the progress of the study and if necessary agreeing changes to the protocol and/or investigators brochure to facilitate the smooth running of the study?CU, CLMF, CMMB, PCB; Trial Management Committee?Principal investigator, Research Physician LARC, CMMB; Administrator?PCB; Study planning?PCB; Organization of steering committee meetings?PCB; Provide annual ethics committee?PCB; Responsible for trial master file?SMML; Advice for lead investigators?GCJ, CU, CLMF, CMMB, SAMF, JET; Data verification?CU; Randomization?CU; Organization of central serum sample collection?SMML; Data Manager; Maintenance of trial IT system and data entry?CU; Data verification?Maintenance of trial IT system and data entry?RB, LARC, SMML.
Funding Information:
RB holds a scholarship from the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES). GTS was supported by scholarship from the University of Sao Paulo for undergraduate students (Programa Unificado de Bolsas-PUB). VAV holds grant from FAPESP (2017/13133-0). PCB holds grants from FAPESP (2015/22814-5; 2016/50336-3) and CNPq (306261/2016-2). CLMF holds grants from CNPq (304436/2018-6) and CAPES-PROEX (0001).
Funding Information:
This study is supported by São Paulo Research Foundation - FAPESP (grant number 2020/12514-2). All processes will be independent from the sponsor.
Keywords
- Breast neoplasms
- Canoeing
- Exercise
- Motivation
- Physical fitness
ASJC Scopus subject areas
- Medicine (miscellaneous)
- Pharmacology (medical)