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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Female; Autonomic Dysfunction; Cardiovascular Diseases in Old Age; Cardiometabolic Syndrome; Metabolism Disorder, Lipid
• Intervention / Treatment: Behavioral: HIIT program (8 weeks); Behavioral: MPI program (8 weeks)

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina Blasco Lafarga, Tenured Professor; Phone Number: 9638 64372; Email: m.cristina.blasco@uv.es

Study Locations

• Spain
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Recruiting
      • Faculty of Physical Activity and Sport Sciences
      • Contact: Cristina Blasco Lafarga, PhD; Phone Number: 9638 64372; Email: m.cristina.blasco@uv.es
      • Sub-Investigator: Jordi Monferrer-Marín, Predoctoral student
      • Sub-Investigator: Ainoa Roldán, PhD
      • Sub-Investigator: Jørn Wulff Helge, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group; 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.	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.; Behavioral: 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.
No Intervention: Control group; Two cohorts of both healthy postmenopausal women and women free of postmenopausal breast cancer recurrence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight measured with a scale (kg)	Preintervention and Postintervention (8 weeks after)
Height	Height measured with a stadiometer (cm)	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)
Lactate	Lactate assessment will be obtained by lactate analyzer (Lactate Scout Sport SensLab GmbH, Leipzig, Germany)	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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Generalitat Valenciana
• Investigators: Principal Investigator: Cristina Blasco Lafarga, Tenured Professor, University of Valencia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Exercise Training; Ageing; Heart Rate Variability; Menopause; Female; Lactate; High Intensity Interval Training; Strength Training; Muscle Power; Metabolic Flexibility; Resting metabolic Rate
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Nervous System Diseases; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Metabolic Syndrome; Metabolic Diseases; Lipid Metabolism Disorders; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: 2024-FIS-3251696; CIACIF/2022/368 (Other Grant/Funding Number: Regional Ministry of Education, Universities and Employment - Generalitat Valenciana)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No