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| ID | Type | Description | Link |
|---|---|---|---|
| CIACIF/2022/368 | Other Grant/Funding Number | Regional Ministry of Education, Universities and Employment - Generalitat Valenciana |
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| Name | Class |
|---|---|
| Generalitat Valenciana | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | 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. |
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| Control group | No Intervention | Two cohorts of both healthy postmenopausal women and women free of postmenopausal breast cancer recurrence. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIIT program (8 weeks) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fat 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 | 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 | Preintervention and Postintervention (8 weeks after) |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight measured with a scale (kg) | Preintervention and Postintervention (8 weeks after) |
| Height | Height measured with a stadiometer (cm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristina Blasco Lafarga, Tenured Professor | Contact | 64372 | 9638 | m.cristina.blasco@uv.es |
| Name | Affiliation | Role |
|---|---|---|
| Cristina Blasco Lafarga, Tenured Professor | University of Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Activity and Sport Sciences | Recruiting | Valencia | Valencia | 46010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35907092 | Result | Monferrer-Marin J, Roldan A, Monteagudo P, Chulvi-Medrano I, Blasco-Lafarga C. Impact of Ageing on Female Metabolic Flexibility: A Cross-Sectional Pilot Study in over-60 Active Women. Sports Med Open. 2022 Jul 30;8(1):97. doi: 10.1186/s40798-022-00487-y. | |
| 35464093 | Result | Blasco-Lafarga C, Monferrer-Marin J, Roldan A, Monteagudo P, Chulvi-Medrano I. Metabolic Flexibility and Mechanical Efficiency in Women Over-60. Front Physiol. 2022 Apr 6;13:869534. doi: 10.3389/fphys.2022.869534. eCollection 2022. |
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| MPI program (8 weeks) | Behavioral | 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. |
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| 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) | Preintervention and Postintervention (8 weeks after) |
| Lean mass | Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg) | 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) | 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) | Preintervention and Postintervention (8 weeks after) |
| Bone Mass | Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg) | Preintervention and Postintervention (8 weeks after) |
| Fat mass | Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg) | 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. | Preintervention and Postintervention (8 weeks after) |
| Oxygen Saturation | The investigators will also assess oxygen saturation in middle finger of the right hand at rest. | Preintervention and Postintervention (8 weeks after) |
| Sarcopenia | The SARC-F will be used to evaluate the risk of sarcopenia | 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. | Preintervention and Postintervention (8 weeks after) |
| Lactate | Lactate assessment will be obtained by lactate analyzer (Lactate Scout Sport SensLab GmbH, Leipzig, Germany) | 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. | 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. | 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). | 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). | Preintervention and Postintervention (8 weeks after) |
| Muscle Power 5STS | Power will be calculated by Power Frail App (Toledo, Spain) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Preintervention and Postintervention (8 weeks after) |
| 33848440 | Result | Frandsen J, Amaro-Gahete FJ, Landgrebe A, Dela F, Ruiz JR, Helge JW, Larsen S. The influence of age, sex and cardiorespiratory fitness on maximal fat oxidation rate. Appl Physiol Nutr Metab. 2021 Oct;46(10):1241-1247. doi: 10.1139/apnm-2021-0080. Epub 2021 Apr 13. |
| 35977864 | Result | Gonzalez-Acedo A, Plaza-Florido A, Amaro-Gahete FJ, Sacha J, Alcantara JMA. Associations between heart rate variability and maximal fat oxidation in two different cohorts of healthy sedentary adults. Nutr Metab Cardiovasc Dis. 2022 Oct;32(10):2338-2347. doi: 10.1016/j.numecd.2022.06.015. Epub 2022 Jun 22. |
| 29697773 | Result | Smith RL, Soeters MR, Wust RCI, Houtkooper RH. Metabolic Flexibility as an Adaptation to Energy Resources and Requirements in Health and Disease. Endocr Rev. 2018 Aug 1;39(4):489-517. doi: 10.1210/er.2017-00211. |
| 29197155 | Result | Sogaard D, Lund MT, Scheuer CM, Dehlbaek MS, Dideriksen SG, Abildskov CV, Christensen KK, Dohlmann TL, Larsen S, Vigelso AH, Dela F, Helge JW. High-intensity interval training improves insulin sensitivity in older individuals. Acta Physiol (Oxf). 2018 Apr;222(4):e13009. doi: 10.1111/apha.13009. Epub 2017 Dec 19. |
| 36270544 | Result | Formighieri C, Muller DC, Saez de Asteasu ML, Mello A, Teodoro JL, Boeno F, Grazioli R, Cunha GDS, Pietta-Dias C, Izquierdo M, Pinto RS, Cadore EL. Interindividual variability of adaptations following either traditional strength or power training combined to endurance training in older men: A secondary analysis of a randomized clinical trial. Exp Gerontol. 2022 Nov;169:111984. doi: 10.1016/j.exger.2022.111984. Epub 2022 Oct 19. |
| 30806875 | Result | Mugele H, Freitag N, Wilhelmi J, Yang Y, Cheng S, Bloch W, Schumann M. High-intensity interval training in the therapy and aftercare of cancer patients: a systematic review with meta-analysis. J Cancer Surviv. 2019 Apr;13(2):205-223. doi: 10.1007/s11764-019-00743-3. Epub 2019 Feb 26. |
| 32819304 | Result | Toohey K, Pumpa K, McKune A, Cooke J, Welvaert M, Northey J, Quinlan C, Semple S. The impact of high-intensity interval training exercise on breast cancer survivors: a pilot study to explore fitness, cardiac regulation and biomarkers of the stress systems. BMC Cancer. 2020 Aug 20;20(1):787. doi: 10.1186/s12885-020-07295-1. |
| 34919906 | Result | Matsubara Y, Kiyohara H, Teratani T, Mikami Y, Kanai T. Organ and brain crosstalk: The liver-brain axis in gastrointestinal, liver, and pancreatic diseases. Neuropharmacology. 2022 Mar 1;205:108915. doi: 10.1016/j.neuropharm.2021.108915. Epub 2021 Dec 15. |
| 41820730 | Derived | Monferrer-Marin J, Roldan A, Helge JW, Blasco-Lafarga C. Vagal Activity and Fat Oxidation Basal Correlates in Older Active Postmenopausal Women: A Cross-Sectional Study. Sports Med Open. 2026 Mar 12;12(1):29. doi: 10.1186/s40798-026-01004-1. |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D052439 | Lipid Metabolism Disorders |
| D054969 | Primary Dysautonomias |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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