Breast Cancer FemalePOWER HealthNCT06336070
Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study
A study testing HIIT program (8 weeks) and MPI program (8 weeks) in people with Breast Cancer Female and Cardiometabolic Syndrome, run by University of Valencia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Breast Cancer Female, Cardiometabolic Syndrome, Metabolism Disorder, Lipid
- What is being tested?
- HIIT program (8 weeks) and MPI program (8 weeks)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Physical Activity and Sport Sciences
Valencia, Valencia, 46010
Cristina Blasco Lafarga, PhD, 64372 ext. 9638, m.cristina.blasco@uv.es
Jordi Monferrer-Marín, Predoctoral student
About this study
Official 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
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
- Breast Cancer Female, Cardiometabolic Syndrome, Metabolism Disorder, Lipid, Autonomic Dysfunction, Cardiovascular Diseases in Old Age
- Being tested
- HIIT program (8 weeks), MPI program (8 weeks)
- 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
- Medical subject headings
- Metabolic Syndrome, Lipid Metabolism Disorders, Primary Dysautonomias, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT program (8 weeks)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 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. Receives: Behavioral: HIIT program (8 weeks); Behavioral: MPI program (8 weeks) |
| Control group | No intervention | Two cohorts of both healthy postmenopausal women and women free of postmenopausal breast cancer recurrence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Preintervention and Postintervention (8 weeks after)
Secondary outcomes (29)
Weight
Weight measured with a scale (kg)
Measured: Preintervention and Postintervention (8 weeks after)
Height
Height measured with a stadiometer (cm)
Measured: 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)
Measured: Preintervention and Postintervention (8 weeks after)
Lean mass
Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Measured: 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)
Measured: 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)
Measured: Preintervention and Postintervention (8 weeks after)
Bone Mass
Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Measured: Preintervention and Postintervention (8 weeks after)
Fat mass
Body composition assessment will be obtained by bioimpedance (Tanita DC-430 MA S; Tokyo, Japan; kg)
Measured: 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.
Measured: Preintervention and Postintervention (8 weeks after)
Oxygen Saturation
The investigators will also assess oxygen saturation in middle finger of the right hand at rest.
Measured: Preintervention and Postintervention (8 weeks after)
Sarcopenia
The SARC-F will be used to evaluate the risk of sarcopenia
Measured: 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.
Measured: Preintervention and Postintervention (8 weeks after)
Lactate
Lactate assessment will be obtained by lactate analyzer (Lactate Scout Sport SensLab GmbH, Leipzig, Germany)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Preintervention and Postintervention (8 weeks after)
Muscle Power 5STS
Power will be calculated by Power Frail App (Toledo, Spain)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Preintervention and Postintervention (8 weeks after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Generalitat Valenciana
- Responsible party
- Principal investigator, Cristina Blasco-Lafarga, University of Valencia
- Investigators
- Cristina Blasco Lafarga, Tenured Professor, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336070
- Sponsor's protocol ID
- 2024-FIS-3251696
- Other IDs
- CIACIF/2022/368
- Acronym
- POWER Health
- Status last verified
- Apr 2024
- First submitted
- 14 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35907092Blasco-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 35464093Frandsen 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 33848440Gonzalez-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 35977864Smith 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 29697773Sogaard 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 29197155Formighieri 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 36270544Mugele 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 30806875Toohey 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 32819304Matsubara 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 34919906Monferrer-Marin J, Roldan A, Helge JW, Blasco-Lafarga C. Vagal Activity and Fat Oxidation Basal Correlates in Older Active Postmenopausal Women: A Cross-Sectional Study. Sports Med Open. 2026 Mar 12;12(1):29. doi: 10.1186/s40798-026-01004-1.
PubMed 41820730
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06336070
- Acronym / sponsor ID
- POWER Health / 2024-FIS-3251696
- Conditions
- Breast Cancer Female, Cardiometabolic Syndrome, Metabolism Disorder, Lipid, Autonomic Dysfunction, Cardiovascular Diseases in Old Age
- Keywords
- Metabolic Flexibility, Heart Rate Variability, Muscle Power, Resting metabolic Rate, Lactate, High Intensity Interval Training, Strength Training, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Generalitat Valenciana
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: HIIT program (8 weeks), Behavioral: MPI program (8 weeks)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. |
| Control group | No intervention | –Two cohorts of both healthy postmenopausal women and women free of postmenopausal breast cancer recurrence. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Exercise group |
| 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. | Behavioural | Exercise group |
Primary outcome
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
29 secondary outcomes
Weight
Time frame: Preintervention and Postintervention (8 weeks after)
Height
Time frame: Preintervention and Postintervention (8 weeks after)
Calf, waist and hip circumferences.
Time frame: Preintervention and Postintervention (8 weeks after)
Lean mass
Time frame: Preintervention and Postintervention (8 weeks after)
Fat-free mass
Time frame: Preintervention and Postintervention (8 weeks after)
Visceral adipose tissue
Time frame: Preintervention and Postintervention (8 weeks after)
Bone Mass
Time frame: Preintervention and Postintervention (8 weeks after)
Fat mass
Time frame: Preintervention and Postintervention (8 weeks after)
Blood Pressure
Time frame: Preintervention and Postintervention (8 weeks after)
Oxygen Saturation
Time frame: Preintervention and Postintervention (8 weeks after)
Sarcopenia
Time frame: Preintervention and Postintervention (8 weeks after)
Physical activity and sedentariness
Time frame: Preintervention and Postintervention (8 weeks after)
Lactate
Time frame: Preintervention and Postintervention (8 weeks after)
Rating Perceived Exertion
Time frame: Preintervention and Postintervention (8 weeks after)
Visual Analogue Scale of Pain
Time frame: Preintervention and Postintervention (8 weeks after)
Cadence
Time frame: Preintervention and Postintervention (8 weeks after)
Mechanical Power
Time frame: Preintervention and Postintervention (8 weeks after)
Muscle Power 5STS
Time frame: Preintervention and Postintervention (8 weeks after)
Basal metabolic rate
Time frame: Preintervention and Postintervention (8 weeks after)
Respiratory exheange ratio at rest
Time frame: Preintervention and Postintervention (8 weeks after)
Fat oxidation at rest
Time frame: Preintervention and Postintervention (8 weeks after)
Carbohydrate oxidation at rest
Time frame: Preintervention and Postintervention (8 weeks after)
Carbohydrate oxidation during incremental test
Time frame: Preintervention and Postintervention (8 weeks after)
Energy expenditure during incremental test
Time frame: Preintervention and Postintervention (8 weeks after)
FATmax intensity
Time frame: Preintervention and Postintervention (8 weeks after)
VO2peak
Time frame: Preintervention and Postintervention (8 weeks after)
Sample Entropy
Time frame: Preintervention and Postintervention (8 weeks after)
SD1/SD2 ratio
Time frame: Preintervention and Postintervention (8 weeks after)
The root mean square of successive differences between normal heartbeats (RMSSD)
Time frame: Preintervention and Postintervention (8 weeks after)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Results publication: PubMed 35907092Monferrer-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.
- Results publication: PubMed 35464093Blasco-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.
- Results publication: PubMed 33848440Frandsen 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.
- Results publication: PubMed 35977864Gonzalez-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.
- Results publication: PubMed 29697773Smith 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.
- Results publication: PubMed 29197155Sogaard 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.
- Results publication: PubMed 36270544Formighieri 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.
- Results publication: PubMed 30806875Mugele 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.
- Results publication: PubMed 32819304Toohey 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.
- Results publication: PubMed 34919906Matsubara 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.
- Derived from this study: PubMed 41820730Monferrer-Marin J, Roldan A, Helge JW, Blasco-Lafarga C. Vagal Activity and Fat Oxidation Basal Correlates in Older Active Postmenopausal Women: A Cross-Sectional Study. Sports Med Open. 2026 Mar 12;12(1):29. doi: 10.1186/s40798-026-01004-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Blasco Lafarga, Tenured Professor principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT program (8 weeks) and MPI program (8 weeks) in people with Breast Cancer Female and Cardiometabolic Syndrome, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Blasco Lafarga, Tenured Professor (64372 ext. 9638, m.cristina.blasco@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat oxidation during incremental test (time frame: Preintervention (only this one in cross-sectional study) and Postintervention (8 weeks after)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06336070, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.