Clinical trial NCT06336070: Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Cardiometabolic Syndrome
Metabolism Disorder, Lipid
Autonomic Dysfunction
Cardiovascular Diseases in Old Age
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
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Generalitat Valenciana
First posted: 2024-03-28
Enrollment: 56
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fat oxidation during incremental test
timeFrame: Preintervention (only this one in cross-sectional study) and Postintervention (8 weeks after)
measure: Detrended Fluctuation Analysis
timeFrame: Preintervention and Postintervention (8 weeks after)
Secondary outcomes:
measure: Weight
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Height
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Calf, waist and hip circumferences.
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Lean mass
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Fat-free mass
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Visceral adipose tissue
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Bone Mass
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Fat mass
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Blood Pressure
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Oxygen Saturation
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Sarcopenia
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Physical activity and sedentariness
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Lactate
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Rating Perceived Exertion
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Visual Analogue Scale of Pain
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Cadence
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Mechanical Power
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Muscle Power 5STS
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Basal metabolic rate
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Respiratory exheange ratio at rest
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Fat oxidation at rest
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Carbohydrate oxidation at rest
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Carbohydrate oxidation during incremental test
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Energy expenditure during incremental test
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: FATmax intensity
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: VO2peak
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: Sample Entropy
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: SD1/SD2 ratio
timeFrame: Preintervention and Postintervention (8 weeks after)
measure: The root mean square of successive differences between normal heartbeats (RMSSD)
timeFrame: Preintervention and Postintervention (8 weeks after)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physical Activity and Sport Sciences
state: Comunidad Valenciana
Study officials:
affiliation: University of Valencia
name: Cristina Blasco Lafarga, Tenured Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.