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

NCT06336070 | Recruiting

• 2 other identifiers: 2024-FIS-3251696CIACIF/2022/368
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

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; Ageing; Menopause; Female; Exercise Training

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Preintervention and Postintervention (8 weeks after)

Secondary Outcomes (29)

• Weight

  Preintervention and Postintervention (8 weeks after)

• Height

  Preintervention and Postintervention (8 weeks after)

• Calf, waist and hip circumferences.

  Preintervention and Postintervention (8 weeks after)

• Lean mass

  Preintervention and Postintervention (8 weeks after)

• Fat-free mass

  Preintervention and Postintervention (8 weeks after)

Study Arms (2)

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.

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.

Interventions

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.

Exercise group

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.

Exercise group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead
• Generalitat Valenciana: collaborator

Study Sites (1)

Faculty of Physical Activity and Sport Sciences

Valencia, Valencia, 46010, Spain

RECRUITING

Related Publications (10)

• 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.

  PMID: 35907092 RESULT

• 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.

  PMID: 35464093 RESULT

• 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.

  PMID: 33848440 RESULT

• 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.

  PMID: 35977864 RESULT

• 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.

  PMID: 29697773 RESULT

• 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.

  PMID: 29197155 RESULT

• 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.

  PMID: 36270544 RESULT

• 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.

  PMID: 30806875 RESULT

• 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.

  PMID: 32819304 RESULT

• 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.

  PMID: 34919906 RESULT

MeSH Terms

Conditions

Metabolic Syndrome; Lipid Metabolism Disorders; Primary Dysautonomias; Breast Neoplasms

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autonomic Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cristina Blasco Lafarga, Tenured Professor

  University of Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Blasco Lafarga, Tenured Professor

CONTACT

64372; m.cristina.blasco@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 28, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)