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

Breast Cancer Female Clinical Trial

— POWER Health  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336070
• Other study ID #: 2024-FIS-3251696
• Secondary ID: CIACIF/2022/368
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: University of Valencia
• Contact: Cristina Blasco Lafarga, Tenured Professor
• Phone: 64372
• Email: m.cristina.blasco[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Breast Cancer Female
• Cardiometabolic Syndrome
• Cardiovascular Diseases
• Cardiovascular Diseases in Old Age
• Lipid Metabolism Disorders
• Metabolic Diseases
• Metabolic Syndrome
• Metabolism Disorder, Lipid
• Primary Dysautonomias

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Faculty of Physical Activity and Sport Sciences	Valencia	Comunidad Valenciana

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Generalitat Valenciana

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View 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 — View 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 202 — View 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. d — View 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. — View 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. — View 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/s11764-0 — View 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. — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Secondary	Weight	Weight measured with a scale (kg)	Preintervention and Postintervention (8 weeks after)
Secondary	Height	Height measured with a stadiometer (cm)	Preintervention and Postintervention (8 weeks after)
Secondary	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)
Secondary	Lean mass	Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)	Preintervention and Postintervention (8 weeks after)
Secondary	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)
Secondary	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)
Secondary	Bone Mass	Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)	Preintervention and Postintervention (8 weeks after)
Secondary	Fat mass	Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)	Preintervention and Postintervention (8 weeks after)
Secondary	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)
Secondary	Oxygen Saturation	The investigators will also assess oxygen saturation in middle finger of the right hand at rest.	Preintervention and Postintervention (8 weeks after)
Secondary	Sarcopenia	The SARC-F will be used to evaluate the risk of sarcopenia	Preintervention and Postintervention (8 weeks after)
Secondary	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)
Secondary	Lactate	Lactate assessment will be obtained by lactate analyzer (Lactate Scout Sport SensLab GmbH, Leipzig, Germany)	Preintervention and Postintervention (8 weeks after)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Muscle Power 5STS	Power will be calculated by Power Frail App (Toledo, Spain)	Preintervention and Postintervention (8 weeks after)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)