RecruitingNCT06336070POWER HealthUpdated Apr 4, 2024

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

An interventional study of HIIT program (8 weeks) and MPI program (8 weeks) in Breast Cancer Female, Cardiometabolic Syndrome and Metabolism Disorder, Lipid, sponsored by University of Valencia. Recruiting at 1 site in Spain. Open to female participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by University of Valencia · Not applicable, Interventional, and Treatment

From the registry’s dates

Started Jan 2024; still recruiting 2 years 9 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 56
Allocation: Randomized
Ages: 35 Years to 75 Years
Sex: Female

Study 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.

Read the 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.

Conditions studied

Breast Cancer Female
Cardiometabolic Syndrome
Metabolism Disorder, Lipid
Autonomic Dysfunction
Cardiovascular Diseases in Old Age

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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

In context

Autonomic Nervous System Diseases

166 studies on the registry are indexed under Autonomic Nervous System Diseases; 36 are open to participants now.

This study's planned enrollment of 56 is above the median of 40 across 107 interventional studies indexed under Autonomic Nervous System Diseases.

Browse Autonomic Nervous System Diseases studies →

Lead sponsor

University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 35 Years to 75 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 56 participants (estimated)

Study arms

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) · Behavioral: MPI program (8 weeks)
No intervention
Control group
Two cohorts of both healthy postmenopausal women and women free of postmenopausal breast cancer recurrence.

Interventions

BehavioralHIIT 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.
BehavioralMPI 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.

What researchers measure

Primary outcomes

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
Time frame: 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
Time frame: Preintervention and Postintervention (8 weeks after)

Secondary outcomes

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

Study locations

1 of 1 sites recruiting

Faculty of Physical Activity and Sport Sciences
Valencia, Comunidad Valenciana 46010, Spain
- Cristina Blasco Lafarga, PhD · Contact · m.cristina.blasco@uv.es · 64372
- Jordi Monferrer-Marín, Predoctoral student · Sub investigator
- Ainoa Roldán, PhD · Sub investigator
- Jørn Wulff Helge, PhD · Sub investigator
Recruiting

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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.2022.111984. Epub 2022 Oct 19. PubMed 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. PubMed 30806875 ↗
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. PubMed 32819304 ↗
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. PubMed 34919906 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06336070
Lead sponsor: University of Valencia
Collaborators: Generalitat Valenciana
Responsible party: Cristina Blasco-Lafarga (Senior Lecturer, University of Valencia) — Principal investigator
First posted: Mar 28, 2024
Start date: Jan 1, 2024
Primary completion: Dec 31, 2027 (estimated)
Completion: Dec 31, 2028 (estimated)
Last update: Apr 4, 2024

Study contacts

Cristina Blasco Lafarga, Tenured Professor

Contact

m.cristina.blasco@uv.es

64372 ext. 9638

Cristina Blasco Lafarga, Tenured Professor

principal investigator · University of Valencia

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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