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

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

NCT ID: NCT06336070

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

Conditions: Official terms:
Autonomic Nervous System Diseases
Primary Dysautonomias
Cardiovascular Diseases
Metabolic Diseases
Metabolic Syndrome
Lipid Metabolism Disorders

Conditions: 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

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: HIIT program (8 weeks)
Description: 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.
Arm group label: Exercise group

Intervention type: Behavioral
Intervention name: MPI program (8 weeks)
Description: 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.
Arm group label: Exercise group

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.

Criteria for 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.

Gender: Female

Minimum age: 35 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Faculty of Physical Activity and Sport Sciences

Address:
City: Valencia
Zip: 46010
Country: Spain

Status: Recruiting

Contact:
Last name: Cristina Blasco Lafarga, PhD

Phone: 64372

Phone ext: 9638
Email: m.cristina.blasco@uv.es

Investigator:
Last name: Jordi Monferrer-Marín, Predoctoral student
Email: Sub-Investigator

Investigator:
Last name: Ainoa Roldán, PhD
Email: Sub-Investigator

Investigator:
Last name: Jørn Wulff Helge, PhD
Email: Sub-Investigator

Start date: January 1, 2024

Completion date: December 31, 2028

Lead sponsor:
Agency: University of Valencia
Agency class: Other

Collaborator:
Agency: Generalitat Valenciana
Agency class: Other

Source: University of Valencia

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06336070