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Effects of home-based exercise training on VO2 in breast cancer patients under adjuvant or neoadjuvant chemotherapy (SAPA): a randomized controlled trial [with consumer summary]
Cornette T, Vincent F, Mandigout S, Antonini M-T, Leobon S, Labrunie A, Venat L, Lavau-Denes S, Tubiana-Mathieu N
European Journal of Physical and Rehabilitation Medicine 2016 Apr;52(2):223-232
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Breast cancer chemotherapy is associated with a decline in measured cardiorespiratory fitness and increased fatigue. Physical activity has emerged as a feasible intervention to limit these side effects. Quantitative evaluation is necessary to propose a better-adapted physical activity and to evaluate efficacy. AIM: We undertook a prospective study to assess the effects of a home-based adapted physical activity (APA) program on aerobic capacity, strength, and fatigue in women treated with adjuvant or neoadjuvant chemotherapy for breast cancer versus usual care. DESIGN: This was an open two-arm, randomized controlled trial. SETTING: Study included outpatient groups in the Department of Physiology and Medical Oncology of a hospital in France. POPULATION: Forty-four patients treated with adjuvant or neoadjuvant chemotherapy for breast cancer. METHODS: Patients were randomly assigned to a control group or an APA group. Intervention consisted of a 3-week, home-based, supervised, combined APA program (endurance and resistance training) during 27 weeks. The primary endpoint was cardiopulmonary function assessed by maximal peak oxygen consumption (VO2peak). Secondary endpoints included a 6-minute Walking Test (6MWT), and assessment of muscular strength, fatigue, quality of life, physical activity level, and anxiety/depression. RESULTS: At 27 weeks, VO2peak increased by 1.83 +/- 0.68 mL/min/kg in the APA group (p = 0.009) and decreased by 1.31 +/- 0.65 mL/min/kg in the control group (p = 0.046). The difference between the two groups was not significant (2.26 +/- 1.53 mL/min/kg, p = 0.140) in intention-to-treat analysis, but it was significant in per protocol analysis (3.49 +/- 1.64 mL/min/kg, p = 0.049). At 27 and 54 weeks, no significant differences were observed between the two groups for the cardiopulmonary exercise test, 6MWT, quadriceps strength, or quality of life. CONCLUSIONS: In breast cancer patients, a home-based supervised program during chemotherapy and radiotherapy treatment may be safe, feasible and increase VO2peak. In this study, heavy evaluation tests explain patient's non-adherence and do not permit to obtain statistically significant results between APA and control groups.

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