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Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study

Postmenopausal Oncological Women Exercising for Recover Their Health. Associations and Changes in Metabolic Flexibility and Autonomic Control After Two Training Programs (Muscle Power vs Metabolic Power): the POWER Health Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06336070
Acronym
POWER Health
Enrollment
56
Registered
2024-03-28
Start date
2024-01-01
Completion date
2028-12-31
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Dysfunction, Breast Cancer Female, Cardiometabolic Syndrome, Cardiovascular Diseases in Old Age, Metabolism Disorder, Lipid

Keywords

Metabolic Flexibility, Heart Rate Variability, Muscle Power, Resting metabolic Rate, Lactate, High Intensity Interval Training, Strength Training, Breast Cancer, Ageing, Menopause, Female, Exercise Training

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.

Interventions

BEHAVIORALHIIT program (8 weeks)

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.

BEHAVIORALMPI program (8 weeks)

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.

Sponsors

Generalitat Valenciana
CollaboratorOTHER
University of Valencia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Fat oxidation during incremental testPreintervention (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 AnalysisPreintervention 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

MeasureTime frameDescription
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)
Lean massPreintervention and Postintervention (8 weeks after)Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Fat-free massPreintervention and Postintervention (8 weeks after)Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Visceral adipose tissuePreintervention and Postintervention (8 weeks after)Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Bone MassPreintervention and Postintervention (8 weeks after)Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Fat massPreintervention and Postintervention (8 weeks after)Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Blood PressurePreintervention and Postintervention (8 weeks after)The investigators will also assess systolic and diastolic blood pressure in the left (whenever possible) arm at rest.
Oxygen SaturationPreintervention and Postintervention (8 weeks after)The investigators will also assess oxygen saturation in middle finger of the right hand at rest.
SarcopeniaPreintervention and Postintervention (8 weeks after)The SARC-F will be used to evaluate the risk of sarcopenia
Physical activity and sedentarinessPreintervention 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.
LactatePreintervention and Postintervention (8 weeks after)Lactate assessment will be obtained by lactate analyzer (Lactate Scout Sport SensLab GmbH, Leipzig, Germany)
Rating Perceived ExertionPreintervention 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 PainPreintervention 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.
WeightPreintervention and Postintervention (8 weeks after)Weight measured with a scale (kg)
Mechanical PowerPreintervention and Postintervention (8 weeks after)Power will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).
Muscle Power 5STSPreintervention and Postintervention (8 weeks after)Power will be calculated by Power Frail App (Toledo, Spain)
Basal metabolic ratePreintervention 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 restPreintervention and Postintervention (8 weeks after)Resting exchange ratio will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions
Fat oxidation at restPreintervention and Postintervention (8 weeks after)Fat oxidation will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions
Carbohydrate oxidation at restPreintervention and Postintervention (8 weeks after)Carbohydrate will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions
Carbohydrate oxidation during incremental testPreintervention 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
Energy expenditure during incremental testPreintervention 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 intensityPreintervention 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
VO2peakPreintervention 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
Sample EntropyPreintervention 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
SD1/SD2 ratioPreintervention 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
CadencePreintervention and Postintervention (8 weeks after)Cadence will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).
HeightPreintervention and Postintervention (8 weeks after)Height measured with a stadiometer (cm)

Countries

Spain

Contacts

Primary ContactCristina Blasco Lafarga, Tenured Professor
m.cristina.blasco@uv.es64372

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026