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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer Female
- Sponsor
- University of Valencia
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Fat oxidation during incremental test
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Cristina Blasco-Lafarga
Senior Lecturer
University of Valencia
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.
Outcomes
Primary Outcomes
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
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
- Fat-free mass(Preintervention and Postintervention (8 weeks after))
- Sample Entropy(Preintervention and Postintervention (8 weeks after))
- Calf, waist and hip circumferences.(Preintervention and Postintervention (8 weeks after))
- Sarcopenia(Preintervention and Postintervention (8 weeks after))
- Cadence(Preintervention and Postintervention (8 weeks after))
- Fat oxidation at rest(Preintervention and Postintervention (8 weeks after))
- Height(Preintervention and Postintervention (8 weeks after))
- Lean mass(Preintervention and Postintervention (8 weeks after))
- Visceral adipose tissue(Preintervention and Postintervention (8 weeks after))
- Basal metabolic rate(Preintervention and Postintervention (8 weeks after))
- Respiratory exheange ratio at rest(Preintervention and Postintervention (8 weeks after))
- Energy expenditure during incremental test(Preintervention and Postintervention (8 weeks after))
- FATmax intensity(Preintervention and Postintervention (8 weeks after))
- Weight(Preintervention and Postintervention (8 weeks after))
- Bone Mass(Preintervention and Postintervention (8 weeks after))
- Fat mass(Preintervention and Postintervention (8 weeks after))
- Lactate(Preintervention and Postintervention (8 weeks after))
- Carbohydrate oxidation during incremental test(Preintervention and Postintervention (8 weeks after))
- Blood Pressure(Preintervention and Postintervention (8 weeks after))
- Oxygen Saturation(Preintervention and Postintervention (8 weeks after))
- Mechanical Power(Preintervention and Postintervention (8 weeks after))
- Physical activity and sedentariness(Preintervention and Postintervention (8 weeks after))
- Rating Perceived Exertion(Preintervention and Postintervention (8 weeks after))
- Visual Analogue Scale of Pain(Preintervention and Postintervention (8 weeks after))
- Muscle Power 5STS(Preintervention and Postintervention (8 weeks after))
- Carbohydrate oxidation at rest(Preintervention and Postintervention (8 weeks after))
- VO2peak(Preintervention and Postintervention (8 weeks after))
- SD1/SD2 ratio(Preintervention and Postintervention (8 weeks after))
- The root mean square of successive differences between normal heartbeats (RMSSD)(Preintervention and Postintervention (8 weeks after))