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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое HIIT 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.
• Поведенческое MPI 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.

Первичные конечные точки

• Fat oxidation during incremental test [Срок оценки: Preintervention (only this one in cross-sectional study) and Postintervention (8 weeks after)]
• Detrended Fluctuation Analysis [Срок оценки: Preintervention and Postintervention (8 weeks after)]

Вторичные конечные точки (12)

• Weight [Срок оценки: Preintervention and Postintervention (8 weeks after)]
• Height [Срок оценки: Preintervention and Postintervention (8 weeks after)]
• Calf, waist and hip circumferences. [Срок оценки: Preintervention and Postintervention (8 weeks after)]
• Lean mass [Срок оценки: Preintervention and Postintervention (8 weeks after)]
• Fat-free mass [Срок оценки: Preintervention and Postintervention (8 weeks after)]
• Visceral adipose tissue [Срок оценки: Preintervention and Postintervention (8 weeks after)]
• Bone Mass [Срок оценки: Preintervention and Postintervention (8 weeks after)]
• Fat mass [Срок оценки: Preintervention and Postintervention (8 weeks after)]
• Blood Pressure [Срок оценки: Preintervention and Postintervention (8 weeks after)]
• Oxygen Saturation [Срок оценки: Preintervention and Postintervention (8 weeks after)]
• Sarcopenia [Срок оценки: Preintervention and Postintervention (8 weeks after)]
• Physical activity and sedentariness [Срок оценки: Preintervention and Postintervention (8 weeks after)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Faculty of Physical Activity and Sport Sciences — Valencia

Публикации

• 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. PMID 35907092
• 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. PMID 35464093
• 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. PMID 33848440
• 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. PMID 35977864
• 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. PMID 29697773
• 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. PMID 29197155
• 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 PMID 36270544
• 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. PMID 30806875

Идентификаторы

NCT: NCT06336070 · 2024-FIS-3251696 · CIACIF/2022/368

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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