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Objectives The aim of this preplanned secondary analysis of a 12-month randomised controlled trial was to investigate the effects of a multicomponent exercise programme combined with daily whey protein, calcium and vitamin D supplementation on cognition in men with prostate cancer treated with androgen deprivation therapy (ADT). Design 12-month, two-arm, randomised controlled trial. Setting University clinical exercise centre. Participants 70 ADT-treated men were randomised to exercise-training plus supplementation (Ex+ Suppl, n=34) or usual care (control, n=36). Intervention Men allocated to Ex + Suppl undertook thrice weekly resistance training with weight-bearing exercise training plus daily whey protein (25 g), calcium (1200 mg) and vitamin D (2000 IU) supplementation. Primary and secondary outcome measures Cognition was assessed at baseline, 6 and 12 months via a computerised battery (CogState), Trail-making test, Rey auditory-verbal learning test and Digit span. Data were analysed with linear mixed models and an intention-to-treat and prespecified per-protocol approach (exercise-training: ≥66%, nutritional supplement: ≥80%). Results Sixty (86%) men completed the trial (Ex + Suppl, n=31; control, n=29). Five (7.1%) men were classified as having mild cognitive impairment at baseline. Median (IQR) adherence to the exercise and supplement was 56% (37%–82%) and 91% (66%–97%), respectively. Ex + Suppl had no effect on cognition at any time. Conclusions A 12-month multicomponent exercise training and supplementation intervention had no significant effect on cognition in men treated with ADT for prostate cancer compared with usual care. Exercise training adherence below recommended guidelines does not support cognitive health in men treated with ADT for prostate cancer. Trial registration number Australian and New Zealand Clinical Trial Registry (ACTRN12614000317695, registered 25/03/2014) and acknowledged under the Therapeutic Goods Administration Clinical Trial Notification Scheme (CT-2015-CTN-03372-1 v1).
Purpose Androgen deprivation therapy (ADT) for prostate cancer (PCa) has multiple adverse effects on musculoskeletal health. This 12-month randomised controlled trial aimed to assess the effects of multi-component exercise training combined with whey protein, calcium and vitamin D supplementation on bone mineral density (BMD), structure and strength, body composition, muscle strength and physical function in ADT-treated men. Methods Seventy ADT-treated men were randomised to exercise plus supplementation (Ex+Suppl; n=34) or usual care (Control; n=36). Ex+Suppl involved thrice weekly progressive resistance training plus weight-bearing impact exercise with daily multi-nutrient supplementation. Primary outcomes were DXA hip and spine areal BMD. Secondary outcomes included: tibia and radius pQCT volumetric BMD, bone structure and strength; DXA body composition; pQCT muscle and fat cross-sectional area and muscle density; muscle strength and physical function. Results Sixty men (86%) completed the study. Mean exercise and supplement adherence were 56% and 77%, respectively. There were no effects of the intervention on bone or body composition outcomes. Ex+Suppl improved leg muscle strength (net difference [95% CI] 14.5% [-0.2, 29.2], P=0.007) and dynamic mobility (four-square-step test time, -9.3% [-17.3, -1.3], P=0.014) relative to controls. Per-protocol analysis of adherent participants (≥66% exercise, ≥80% supplement) showed Ex+Suppl preserved femoral neck aBMD (1.9% [0.1, 3.8], P=0.026) and improved total body lean mass (1.0 kg [-0.23, 2.22], P=0.044) relative to controls. Conclusion Exercise training combined with multi-nutrient supplementation had limited effect on ameliorating the adverse musculoskeletal consequences of ADT, likely related to the modest intervention adherence.