POWER Health is a randomized clinical trial with a two-arm parallel design whose objectives are 1) to study metabolic flexibility and autonomic function (both capacities that describe cardiovascular health) in a sample of postmenopausal oncological women vs postmenopausal untreated controls (CT); and 2) to analyze the impact of two different 8-week physical exercise supervised interventions: HIIT training vs strength training focused on muscle power, on both cardiovascular capacities in these populations.
Nowadays, breast cancer is the most common type of cancer worldwide, accounting for 30% of all cancers in Spanish women in 2023. Cancer is also the second leading cause of death in developed countries, following cardiovascular diseases, with which it shares a close relationship. Additionally, we know that the incidence of breast cancer increases with age, experiencing a rise after menopause. However, lifestyle and physical exercise are known to improve the prevention, prognosis, and survival of this disease, as well as enhance quality of life in these patients. Indeed, recent studies have highlighted the relevance of cardiovascular health in this oncological process, as well as the potential of physical exercise interventions to improve cardiovascular health following the disease. POWER Health is a randomized clinical trial aimed at studying metabolic flexibility and autonomic health in a population of breast cancer recurrence-free women (RFC) compared to postmenopausal untreated controls (CT), along with the implementation of two supervised exercise interventions in both populations. These interventions will last for 8 weeks, one involving HIIT exercise focused on improving metabolic power (MPI), and the other one involving strength exercise focused on enhancing muscular power, with the hypothesis of better metabolic flexibility and autonomic function, and consequently, better cardiovascular health. POWER health is a mixed method design: cross-sectional \& longitudinal study. Given the feasibility and simple application of POWER Health, this clinical trial will contribute to the prevention and improvement of the health of postmenopausal women, with an important clinical and economic impact, not only in the scientific community but also in clinical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Metabolic Power Training: A High Intensity Interval Training (HIIT) intervention, 3 times per week (30 min session) during 8 weeks with professional supervision and intensities adapted and modified during the intervention period.
Muscle Power Intervention (MPI), 2 times per week (45 min session) during 8 weeks with professional supervision and intensities adapted and modified during the intervention period.
Faculty of Physical Activity and Sport Sciences
Valencia, Valencia, Spain
RECRUITINGFat oxidation during incremental test
Fat oxidation rates calculated from VO2 and VCO2 values collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) and after applying Frayn's stoichiometric formulae, during an incremental test from 0.45 W/kg with 0.15W/kg each 4-min step
Time frame: Preintervention (only this one in cross-sectional study) and Postintervention (8 weeks after)
Detrended Fluctuation Analysis
Non-linear mathematical variable that allows collecting physiological information and vagal activity of the organism, analysed in 2-minute intervals by Kubios Scientific software (Kuopio, Finland), during the incremental test
Time frame: Preintervention and Postintervention (8 weeks after)
Weight
Weight measured with a scale (kg)
Time frame: Preintervention and Postintervention (8 weeks after)
Height
Height measured with a stadiometer (cm)
Time frame: Preintervention and Postintervention (8 weeks after)
Calf, waist and hip circumferences.
Calf, waist and hip circumferences will be assessed with an anthropometric tape measure (cm)
Time frame: Preintervention and Postintervention (8 weeks after)
Lean mass
Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Time frame: Preintervention and Postintervention (8 weeks after)
Fat-free mass
Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Time frame: Preintervention and Postintervention (8 weeks after)
Visceral adipose tissue
Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Time frame: Preintervention and Postintervention (8 weeks after)
Bone Mass
Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Time frame: Preintervention and Postintervention (8 weeks after)
Fat mass
Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Time frame: Preintervention and Postintervention (8 weeks after)
Blood Pressure
The investigators will also assess systolic and diastolic blood pressure in the left (whenever possible) arm at rest.
Time frame: Preintervention and Postintervention (8 weeks after)
Oxygen Saturation
The investigators will also assess oxygen saturation in middle finger of the right hand at rest.
Time frame: Preintervention and Postintervention (8 weeks after)
Sarcopenia
The SARC-F will be used to evaluate the risk of sarcopenia
Time frame: Preintervention and Postintervention (8 weeks after)
Physical activity and sedentariness
The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. Minimum value = 0 min/day of physical activity // Maximum value = 1440 min/day of physical activity. Higher scores imply a more physically active pattern.
Time frame: Preintervention and Postintervention (8 weeks after)
Lactate
Lactate assessment will be obtained by lactate analyzer (Lactate Scout Sport SensLab GmbH, Leipzig, Germany)
Time frame: Preintervention and Postintervention (8 weeks after)
Rating Perceived Exertion
The Rating Perceived Exertion (RPE) of Borg scale will be used to obtain the perceived effort. Minimum value: 1 // Maximum value: 10. Higher scores mean a worse outcome.
Time frame: Preintervention and Postintervention (8 weeks after)
Visual Analogue Scale of Pain
The Visual Analogue Scale of Pain (VAS) scale will be used to obtain the local pain assessment. Minimum value: 1 // Maximum value: 10. Higher scores mean a worse outcome.
Time frame: Preintervention and Postintervention (8 weeks after)
Cadence
Cadence will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).
Time frame: Preintervention and Postintervention (8 weeks after)
Mechanical Power
Power will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).
Time frame: Preintervention and Postintervention (8 weeks after)
Muscle Power 5STS
Power will be calculated by Power Frail App (Toledo, Spain)
Time frame: Preintervention and Postintervention (8 weeks after)
Basal metabolic rate
Metabolic rate will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions
Time frame: Preintervention and Postintervention (8 weeks after)
Respiratory exheange ratio at rest
Resting exchange ratio will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions
Time frame: Preintervention and Postintervention (8 weeks after)
Fat oxidation at rest
Fat oxidation will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions
Time frame: Preintervention and Postintervention (8 weeks after)
Carbohydrate oxidation at rest
Carbohydrate will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions
Time frame: Preintervention and Postintervention (8 weeks after)
Carbohydrate oxidation during incremental test
Carbohydrate oxidation rates will be calculated from VO2 and VCO2 values collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) and after applying Frayn's stoichiometric formulae, during an incremental test from 0.45 W/kg with 0.15W/kg each 4-min step
Time frame: Preintervention and Postintervention (8 weeks after)
Energy expenditure during incremental test
Energy expenditure rate will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test
Time frame: Preintervention and Postintervention (8 weeks after)
FATmax intensity
FATmax will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test
Time frame: Preintervention and Postintervention (8 weeks after)
VO2peak
VO2peak will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test
Time frame: Preintervention and Postintervention (8 weeks after)
Sample Entropy
Non-linear mathematical variable that allows collecting physiological information and parasympathetic activity of the organism, analysed in 3-minute intervals by Kubios Scientific software (Kuopio, Finland), during the incremental test
Time frame: Preintervention and Postintervention (8 weeks after)
SD1/SD2 ratio
Linear mathematical variable that allows collecting physiological information and parasympathetic activity of the organism, analysed in 2-minute intervals by Kubios Scientific software (Kuopio, Finland), during the incremental test
Time frame: Preintervention and Postintervention (8 weeks after)
The root mean square of successive differences between normal heartbeats (RMSSD)
Linear mathematical variable that allows collecting physiological information and parasympathetic activity of the organism, analysed in 2-minute intervals by Kubios Scientific software (Kuopio, Finland), during the incremental test
Time frame: Preintervention and Postintervention (8 weeks after)
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