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Randomised controlled trial of a home-based physical activity intervention in breast cancer survivors
Lahart IM, Metsios GS, Nevill AM, Kitas GD, Carmichael AR
BMC Cancer 2016 Mar 17;16(234):Epub
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; 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: To improve adherence to physical activity (PA), behavioural support in the form of behavioural change counselling may be necessary. However, limited evidence of the effectiveness of home-based PA combined with counselling in breast cancer patients exists. The aim of this current randomised controlled trial with a parallel group design was to evaluate the effectiveness of a home-based PA intervention on PA levels, anthropometric measures, health-related quality of life (HRQoL), and blood biomarkers in breast cancer survivors. METHODS: Eighty post-adjuvant therapy invasive breast cancer patients (age 53.6 +/- 9.4 years; height 161.2 +/- 6.8 cm; mass 68.7 +/- 10.5 kg) were randomly allocated to a 6-month home-based PA intervention or usual care. The intervention group received face-to-face and telephone PA counselling aimed at encouraging the achievement of current recommended PA guidelines. All patients were evaluated for our primary outcome, PA (International PA Questionnaire) and secondary outcomes, mass, BMI, body fat %, HRQoL (Functional assessment of Cancer Therapy-Breast), insulin resistance, triglycerides (TG) and total (TC), high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C) cholesterol were assessed at baseline and at 6-months. RESULTS: On the basis of linear mixed-model analyses adjusted for baseline values performed on 40 patients in each group, total, leisure and vigorous PA significantly increased from baseline to post-intervention in the intervention compared to usual care (between-group differences 578.5 MET-min/wk, p = 0.024, 382.2 MET-min/wk, p = 0.010, and 264.1 MET-min/wk, p = 0.007, respectively). Both body mass and BMI decreased significantly in the intervention compared to usual care (between-group differences -1.6 kg, p = 0.040, and -0.6 kg/m2, p = 0.020, respectively). Of the HRQoL variables, FACT-Breast, Trial Outcome Index, functional wellbeing, and breast cancer subscale improved significantly in the PA group compared to the usual care group (between-group differences 5.1, p = 0.024; 5.6, p = 0.001; 1.9 p = 0.025; and 2.8, p = 0.007, respectively). Finally, TC and LDL-C was significantly reduced in the PA group compared to the usual care group (between-group differences -0.38 mmol/L, p = 0.001; and -0.3 mmol/L, p = 0.023, respectively). CONCLUSIONS: We found that home-based PA resulted in significant albeit small to moderate improvements in self-reported PA, mass, BMI, breast cancer specific HRQoL, and TC and LDL-C compared with usual care. CLINICALTRIALS.GOV IDENTIFIER: NCT02408107 (March 25, 2015).

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