Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study
- Conditions
- Breast Cancer FemaleMetabolism Disorder, LipidCardiovascular Diseases in Old AgeAutonomic DysfunctionCardiometabolic Syndrome
- Interventions
- Behavioral: HIIT program (8 weeks)Behavioral: MPI program (8 weeks)
- Registration Number
- NCT06336070
- Lead Sponsor
- University of Valencia
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 56
- Patients diagnosed of relapse free-cancer (RFC) or patients not diagnosed of any cancer at least the last 15 years (CG)
- Aged between 35 and 75 years
- Diagnostic of breast cancer (i.e., including ductal carcinoma, invasive carcinoma, triple negative; RFC) or physiological menopause (CG)
- Not participating in a nutritional/dietary intervention
- Not being physically active (i.e., not to be participating in any physical exercise program in the last 3 months, or performing less than 600 metabolic equivalents (METS)/week of moderate-vigorous physical activity).
- To be capable and willing to provide informed consent
- Not to suffer from any specific condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise intervention (i.e., determined by the research staff).
- Medical contraindication for being engaged in an exercise.
- Additional surgery planned within the intervention
- Consuming usually betablocker or any drugs alterning nervous system functioning
- History of another primary invasive cancer (RFC) or suffer a serious chronic illness (CG)
- To present any of the following cardiac conditions: (i) myocardial infarction or coronary revascularization procedure within prior 3 months, (ii) uncontrolled hypertension (i.e., systolic ≥180 mmHg or diastolic ≥100 mmHg), (iii) uncontrolled arrhythmias (iv) valvular disease clinically significant, (v) decompensated heart failure or (vi) to suffer from known aortic aneurysm.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise group MPI program (8 weeks) Two cohorts of both healthy postmenopausal women and women free of postmenopausal breast cancer recurrence. Each of the groups will be split into two different exercise programmes. Both programmes, High Intensity Interval Training (HIIT) programme (metabolic power training) and Muscle Power Intervention (MPI) programme will consist of 8 weeks. Exercise group HIIT program (8 weeks) Two cohorts of both healthy postmenopausal women and women free of postmenopausal breast cancer recurrence. Each of the groups will be split into two different exercise programmes. Both programmes, High Intensity Interval Training (HIIT) programme (metabolic power training) and Muscle Power Intervention (MPI) programme will consist of 8 weeks.
- Primary Outcome Measures
Name Time Method Fat oxidation during incremental test Preintervention (only this one in cross-sectional study) and Postintervention (8 weeks after) 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
Detrended Fluctuation Analysis Preintervention and Postintervention (8 weeks after) 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
- Secondary Outcome Measures
Name Time Method Fat-free mass Preintervention and Postintervention (8 weeks after) Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Sample Entropy Preintervention and Postintervention (8 weeks after) 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
Calf, waist and hip circumferences. Preintervention and Postintervention (8 weeks after) Calf, waist and hip circumferences will be assessed with an anthropometric tape measure (cm)
Sarcopenia Preintervention and Postintervention (8 weeks after) The SARC-F will be used to evaluate the risk of sarcopenia
Cadence Preintervention and Postintervention (8 weeks after) Cadence will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).
Fat oxidation at rest Preintervention and Postintervention (8 weeks after) Fat oxidation will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions
Height Preintervention and Postintervention (8 weeks after) Height measured with a stadiometer (cm)
Lean mass Preintervention and Postintervention (8 weeks after) Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Visceral adipose tissue Preintervention and Postintervention (8 weeks after) Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Basal metabolic rate Preintervention and Postintervention (8 weeks after) Metabolic rate will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions
Respiratory exheange ratio at rest Preintervention and Postintervention (8 weeks after) Resting exchange ratio will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions
Energy expenditure during incremental test Preintervention and Postintervention (8 weeks after) Energy expenditure rate will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test
FATmax intensity Preintervention and Postintervention (8 weeks after) FATmax will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test
Weight Preintervention and Postintervention (8 weeks after) Weight measured with a scale (kg)
Bone Mass Preintervention and Postintervention (8 weeks after) Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Fat mass Preintervention and Postintervention (8 weeks after) Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Lactate Preintervention and Postintervention (8 weeks after) Lactate assessment will be obtained by lactate analyzer (Lactate Scout Sport SensLab GmbH, Leipzig, Germany)
Carbohydrate oxidation during incremental test Preintervention and Postintervention (8 weeks after) 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
Blood Pressure Preintervention and Postintervention (8 weeks after) The investigators will also assess systolic and diastolic blood pressure in the left (whenever possible) arm at rest.
Oxygen Saturation Preintervention and Postintervention (8 weeks after) The investigators will also assess oxygen saturation in middle finger of the right hand at rest.
Mechanical Power Preintervention and Postintervention (8 weeks after) Power will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).
Physical activity and sedentariness Preintervention and Postintervention (8 weeks after) 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.
Rating Perceived Exertion Preintervention and Postintervention (8 weeks after) 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.
Visual Analogue Scale of Pain Preintervention and Postintervention (8 weeks after) 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.
Muscle Power 5STS Preintervention and Postintervention (8 weeks after) Power will be calculated by Power Frail App (Toledo, Spain)
Carbohydrate oxidation at rest Preintervention and Postintervention (8 weeks after) Carbohydrate will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions
VO2peak Preintervention and Postintervention (8 weeks after) VO2peak will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test
SD1/SD2 ratio Preintervention and Postintervention (8 weeks after) 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
The root mean square of successive differences between normal heartbeats (RMSSD) Preintervention and Postintervention (8 weeks after) 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
Trial Locations
- Locations (1)
Faculty of Physical Activity and Sport Sciences
🇪🇸Valencia, Comunidad Valenciana, Spain