Objectives | Hypotheses |
---|---|
Main objective • To evaluate the effects of a HIIT versus placebo, conducted simultaneously with first-line chemotherapy regimen on CRCI, in women with breast cancer | Main hypothesis • In women with breast cancer, the decline in HVLT-R-, TMT-A/B- and COWAT test performance from baseline to completion of the exercise-intervention, is significantly smaller in the HIIT group compared to the control group (hypothesis A) |
Secondary objective • To evaluate the effects of a HIIT versus placebo, conducted simultaneously with first-line chemotherapy regimen on self-perceived cognitive performance, in women with breast cancer | Secondary hypotheses • In women with breast cancer, the decline of FACT-COG scores from baseline to completion of the exercise-intervention/to 6-months follow-upa, is significantly smaller in the HIIT group compared to the control group (hypothesis B) |
• To evaluate the effects of a HIIT versus placebo, conducted simultaneously with first-line chemotherapy regimen on executive functioning subdomain response inhibition, in women with breast cancer | • In women with breast cancer, the decline of INHIB performance from baseline to completion of the exercise-intervention/to 6-months follow up, is significantly smaller in the HIIT group compared to the control group (hypothesis C) |
• To evaluate the effects of a HIIT versus placebo, conducted simultaneously with first-line chemotherapy regimen on proinflammatory marker expression, in women with breast cancer | • In women with breast cancer, the increase of serum levels of TNF-α, IL-6, IL-1α, IL-1β, CRP from baseline to completion of the exercise-intervention/to 6-months follow up, is significantly smaller in the HIIT group compared to the control group (hypothesis D) |
• To evaluate the effects of a HIIT versus placebo, conducted simultaneously with first-line chemotherapy regimen on antiinflammatory marker expression, in women with breast cancer | • In women with breast cancer, the decrease of serum levels of IL-1RA, IL-10 from baseline to completion of the exercise-intervention/to 6-months follow up, is significantly smaller in the HIIT group compared to the control group (hypothesis E) |
• To evaluate the effects of a HIIT versus placebo, conducted simultaneously with first-line chemotherapy regimen on neurotrophin expression, in women with breast cancer | • In women with breast cancer, the decrease of BDNF serum level from baseline to completion of the exercise-intervention/to 6-months follow up, is significantly smaller in the HIIT group compared to the control group (hypothesis F) |
• To evaluate the effects of a HIIT versus placebo, conducted simultaneously with first-line chemotherapy regimen on growth factor expression, in women with breast cancer | • In women with breast cancer, the decrease of VEGF and IGF-1 serum levels from baseline to completion of the exercise-intervention/to 6-months follow up, is significantly smaller in the HIIT group compared to the control group (hypothesis G) |
• To evaluate the effects of a HIIT versus placebo, conducted simultaneously with first-line chemotherapy regimen on physical fitness, in women with breast cancer | • In women with breast cancer, the decrease of watts per kilogram and VO2peak measured during IXT from baseline to completion of the exercise-intervention/to 6-months follow up, is significantly smaller in the HIIT group compared to the control group (hypothesis H) |
• To evaluate the effects of a HIIT versus placebo, conducted simultaneously with first-line chemotherapy regimen on anxiety, fatigue, quality of life, sleep disturbances and chemotherapy compliance, in women with breast cancer | • In women with breast cancer, the change of HADS-D, MFI-20, EORTC-QLQ-C30, QOL-BR23 and PSQI scores from baseline to completion of the exercise-intervention/to 6-months follow up, is significantly more favorable in the HIIT group compared to the control group (hypothesis I) |
• To evaluate the sustainability of the effects of a HIIT versus placebo conducted simultaneously with first-line chemotherapy regimen on CRCI in women with breast cancer | • In women with breast cancer, the decline in HVLT-R-, TMT-A/B- and COWAT test performance from baseline to 6-months follow up is significantly smaller in the HIIT group compared to the control group (hypothesis J) |
Exploratory mediation analysis | |
• To evaluate if the change in proinflammatory marker expression, from baseline to completion of the exercise-intervention, partially mediates the effect of the exercise intervention on the change of cognitive performance, from baseline to completion of the exercise-intervention, in women with breast cancer. | • In women with breast cancer, there is a significant indirect effect of exercise intervention on the change of HVLT-R−/TMT-A/B-/COWAT test performance, from baseline to completion of the exercise-intervention, through the change of TNF-α/IL-6/IL-1α/IL-1β/CRP serum level, from baseline to completion of the exercise-intervention (hypothesis K) |
• To evaluate if the change in antiinflammatory marker expression, from baseline to completion of the exercise-intervention, partially mediates the effect of the exercise intervention on the change of cognitive performance, from baseline to completion of the exercise-intervention, in women with breast cancer. | • In women with breast cancer, there is a significant indirect effect of exercise intervention on the change of HVLT-R−/TMT-A/B-/COWAT test performance, from baseline to completion of the exercise-intervention, through the change of IL-1RA/IL-10 serum level, from baseline to completion of the exercise-intervention (hypothesis L) |
• To evaluate if the change in neurotrophin marker expression, from baseline to completion of the exercise-intervention, partially mediates the effect of the exercise intervention on the change of cognitive performance, from baseline to completion of the exercise-intervention, in women with breast cancer. | • In women with breast cancer, there is a significant indirect effect of exercise intervention on the change of HVLT-R−/TMT-A/B-/COWAT test performance, from baseline to completion of the exercise-intervention, through the change of BDNF serum level, from baseline to completion of the exercise-intervention (hypothesis M) |
• To evaluate if the change in growth factor marker expression, from baseline to completion of the exercise-intervention, partially mediates the effect of the exercise intervention on the change of cognitive performance, from baseline to completion of the exercise-intervention, in women with breast cancer. | • In women with breast cancer, there is a significant indirect effect of exercise intervention on the change of HVLT-R−/TMT-A/B-/COWAT test performance, from baseline to completion of the exercise-intervention, through the change of VEGF/IGF-1 serum level, from baseline to completion of the exercise-intervention (hypothesis N) |