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NCT Number: NCT06336070

Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: 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.

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Key information

Conditions

Breast Cancer Female Autonomic Dysfunction Autonomic Nervous System Diseases Breast Diseases Breast Neoplasms Cardiometabolic Syndrome Cardiovascular Diseases in Old Age Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Metabolism Disorder, Lipid Neoplasms Neoplasms by Site Nervous System Diseases Nutritional and Metabolic Diseases Primary Dysautonomias Skin Diseases Skin and Connective Tissue Diseases

Age range

35 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Activity and Sport Sciences

Valencia, 46010, Spain

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIIT program (8 weeks)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Fat oxidation during incremental test

    Time frame: Preintervention (only this one in cross-sectional study) and Postintervention (8 weeks after)

    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

  2. Detrended Fluctuation Analysis

    Time frame: Preintervention and Postintervention (8 weeks after)

    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

Secondary outcomes

  1. Weight

    Time frame: Preintervention and Postintervention (8 weeks after)

    Weight measured with a scale (kg)

  2. Height

    Time frame: Preintervention and Postintervention (8 weeks after)

    Height measured with a stadiometer (cm)

  3. Calf, waist and hip circumferences.

    Time frame: Preintervention and Postintervention (8 weeks after)

    Calf, waist and hip circumferences will be assessed with an anthropometric tape measure (cm)

  4. Lean mass

    Time frame: Preintervention and Postintervention (8 weeks after)

    Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)

  5. Fat-free mass

    Time frame: Preintervention and Postintervention (8 weeks after)

    Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)

  6. Visceral adipose tissue

    Time frame: Preintervention and Postintervention (8 weeks after)

    Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)

  7. Bone Mass

    Time frame: Preintervention and Postintervention (8 weeks after)

    Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)

  8. Fat mass

    Time frame: Preintervention and Postintervention (8 weeks after)

    Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)

  9. Blood Pressure

    Time frame: Preintervention and Postintervention (8 weeks after)

    The investigators will also assess systolic and diastolic blood pressure in the left (whenever possible) arm at rest.

  10. Oxygen Saturation

    Time frame: Preintervention and Postintervention (8 weeks after)

    The investigators will also assess oxygen saturation in middle finger of the right hand at rest.

  11. Sarcopenia

    Time frame: Preintervention and Postintervention (8 weeks after)

    The SARC-F will be used to evaluate the risk of sarcopenia

  12. Physical activity and sedentariness

    Time frame: Preintervention and Postintervention (8 weeks after)

    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.

  13. Lactate

    Time frame: Preintervention and Postintervention (8 weeks after)

    Lactate assessment will be obtained by lactate analyzer (Lactate Scout Sport SensLab GmbH, Leipzig, Germany)

  14. Rating Perceived Exertion

    Time frame: Preintervention and Postintervention (8 weeks after)

    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.

  15. Visual Analogue Scale of Pain

    Time frame: Preintervention and Postintervention (8 weeks after)

    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.

  16. Cadence

    Time frame: Preintervention and Postintervention (8 weeks after)

    Cadence will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).

  17. Mechanical Power

    Time frame: Preintervention and Postintervention (8 weeks after)

    Power will be monitorized by the smart roller Saris H3 (CycleOps Hammer Direct Drive Trainer, Saris, Madison, USA).

  18. Muscle Power 5STS

    Time frame: Preintervention and Postintervention (8 weeks after)

    Power will be calculated by Power Frail App (Toledo, Spain)

  19. Basal metabolic rate

    Time frame: Preintervention and Postintervention (8 weeks after)

    Metabolic rate will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

  20. Respiratory exheange ratio at rest

    Time frame: Preintervention and Postintervention (8 weeks after)

    Resting exchange ratio will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

  21. Fat oxidation at rest

    Time frame: Preintervention and Postintervention (8 weeks after)

    Fat oxidation will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

  22. Carbohydrate oxidation at rest

    Time frame: Preintervention and Postintervention (8 weeks after)

    Carbohydrate will be registered by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) in baseline conditions

  23. Carbohydrate oxidation during incremental test

    Time frame: Preintervention and Postintervention (8 weeks after)

    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

  24. Energy expenditure during incremental test

    Time frame: Preintervention and Postintervention (8 weeks after)

    Energy expenditure rate will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test

  25. FATmax intensity

    Time frame: Preintervention and Postintervention (8 weeks after)

    FATmax will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test

  26. VO2peak

    Time frame: Preintervention and Postintervention (8 weeks after)

    VO2peak will be calculated will be collected by indirect calorimetry (COSMED K5 portable metabolic analyzer, Rome, Italy) during an incremental test

  27. Sample Entropy

    Time frame: Preintervention and Postintervention (8 weeks after)

    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

  28. SD1/SD2 ratio

    Time frame: Preintervention and Postintervention (8 weeks after)

    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

  29. The root mean square of successive differences between normal heartbeats (RMSSD)

    Time frame: Preintervention and Postintervention (8 weeks after)

    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

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Generalitat Valenciana

Registry information

Official study 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

Acronym: POWER Health

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 28, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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