Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-03 @ 6:47 AM
Study NCT ID:
NCT05544357
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2022-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Adaptations to Resistance Exercise: Effect of Set Configuration on Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2022-09-10', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baroreflex sensitivity', 'timeFrame': '25 minutes', 'description': 'Simultaneous electrocardiogram and beat-to-beat blood pressure recordings obtained by a photoplethysmography sensor will be used for calculating baroreflex sensitivity by sequential methods. Units: mmHg/ms'}, {'measure': 'Blood pressure', 'timeFrame': '25 minutes', 'description': 'Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg'}, {'measure': 'Heart rate variability in time domain', 'timeFrame': '25 minutes', 'description': 'Standard deviation of the normal-to-normal interval (SDNN) and root of the mean squared differences of successive NN intervals (RMSSD) will be obtained by analyzing inter-beat intervals from electrocardiogram recordings. Units: ms'}, {'measure': 'Heart rate variability in frequency domain', 'timeFrame': '25 minutes', 'description': 'Obtained from spectral analysis of electrocardiogram recordings. High (HF) and Low (LF) frequency bands power will be determined by Fast Fourier Transformation method. Units: ms2/Hz'}, {'measure': 'Blood pressure variability', 'timeFrame': '25 minutes', 'description': 'It will be calculated by spectral analysis of beat-to-beat blood pressure recordings obtained by a photoplethysmography sensor. Units: mmHg2/Hz'}, {'measure': 'Resting metabolic rate', 'timeFrame': '60 minutes', 'description': 'It will be obtained by measuring oxygen consumption at rest. Units: kcal/·day'}, {'measure': 'Arterial stiffness', 'timeFrame': '15 minutes', 'description': 'It will be assessed by finger-toe pulse wave velocity method. Units: m/s'}, {'measure': 'Bone mineral density', 'timeFrame': '10 minutes', 'description': 'It will be obtained by a Ultrasound Bone Densitometer. Units: g/cm'}], 'secondaryOutcomes': [{'measure': 'Skeletal muscle mass', 'timeFrame': '10 minutes', 'description': 'Estimated by Bioelectrical impedance analysis. Units: kg and percentage of body mass'}, {'measure': 'Fat mass', 'timeFrame': '10 minutes', 'description': 'Estimated by Bioelectrical impedance analysis. Units: kg and percentage of body mass'}, {'measure': 'Body mass', 'timeFrame': '10 minutes', 'description': 'Measured in kg'}, {'measure': 'Body mass index', 'timeFrame': '2 minutes', 'description': 'Measured in kg/m\\^2'}, {'measure': 'Height', 'timeFrame': '10 minutes', 'description': 'Measured in m'}, {'measure': 'Muscle thickness', 'timeFrame': '20 minutes', 'description': 'Measured with an ultrasound device. Units: mm'}, {'measure': 'Torque-velocity relationship', 'timeFrame': '60 minutes', 'description': 'Relationship between torque (N/m) and angular velocity (°/s). Obtained by performing maximum torque at specific velocities in an isokinetic dynamometer'}, {'measure': 'Power-velocity relationship', 'timeFrame': '60 minutes', 'description': 'Relationship betweenPower (W) and angular velocity (°/s). Obtained by performing maximum torque at specific velocities in an isokinetic dynamometer'}, {'measure': 'Maximum isometric torque', 'timeFrame': '60 minutes', 'description': 'Maximum torque recorded at fixed angular position. It will be measured with an isokinetic dynamometer. Units: N/m'}, {'measure': 'Lipid profile to determine cardiovascular risk', 'timeFrame': '5 minutes', 'description': '* Total Cholesterol in mg/dL\n* High-Density Lipoprotein in mg/dL\n* Triglycerides in mg/dL\n* Calculated Low-Density Lipoprotein in mg/dL'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['resistance training', 'postmenopausal women', 'cardiovascular responses', 'cardiovascular adaptations'], 'conditions': ['Postmenopausal', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '41369549', 'type': 'DERIVED', 'citation': 'Iglesias-Soler E, Farinas J, Rua-Alonso M, Rial-Vazquez J, Nine I, Revuelta-Lera B. Shorter Set Configurations Attenuate Performance Loss and Lactatemia During Resistance Training in Postmenopausal Women: A Randomized Crossover Trial (CARE Project). J Strength Cond Res. 2025 Dec 5. doi: 10.1519/JSC.0000000000005301. Online ahead of print.'}, {'pmid': '41334240', 'type': 'DERIVED', 'citation': 'Rial-Vazquez J, Rua-Alonso M, Enriquez-Gonzalez MG, Nine I, Rivera-Mejia SL, Revuelta-Lera B, Farinas J, Iglesias-Soler E. Cardiovascular adaptations to resistance training with different set configurations in postmenopausal women: a study protocol for a randomised controlled trial (CARE project). BMJ Open Sport Exerc Med. 2025 Nov 28;11(4):e003052. doi: 10.1136/bmjsem-2025-003052. eCollection 2025.'}, {'pmid': '39401188', 'type': 'DERIVED', 'citation': 'Nine I, Padron-Cabo A, Carballeira E, Rial-Vazquez J, Rua-Alonso M, Farinas J, Giraldez-Garcia M, Iglesias-Soler E. Acute cardiovascular responses of postmenopausal women to resistance training sessions differing in set configuration: A study protocol for a crossover trial. PLoS One. 2024 Oct 14;19(10):e0311524. doi: 10.1371/journal.pone.0311524. eCollection 2024.'}, {'pmid': '38916283', 'type': 'DERIVED', 'citation': 'Bohn L, Rial-Vazquez J, Nine I, Rua-Alonso M, Farinas J, Giraldez-Garcia MA, Mota J, Iglesias-Soler E. Arterial stiffness assessment by pulse wave velocity in postmenopausal women: comparison between noninvasive devices. Menopause. 2024 Aug 1;31(8):709-715. doi: 10.1097/GME.0000000000002383. Epub 2024 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this project is to analyze the effect of set configuration of resistance exercise on cardiovascular responses and adaptations of postmenopausal women. Additionally, since previous studies have shown that individual´s blood pressure level can influence on the impact of resistance training programs on cardiovascular changes, we aim to contrast acute and chronic changes to resistance training programs in normotensive and hypertensive postmenopausal women.', 'detailedDescription': 'Menopause causes hormonal changes that affect to acute and chronic physiological responses to exercise of postmenopausal women. In this regard, studies about the cardiovascular responses to resistance training in women are scarce, being particularly relevant to identify those load parameters that modulate these adaptations. Previous studies have identified that set configuration of muscular exercise influence on cardiovascular stress, albeit these results have been mainly obtained in healthy young male subjects.\n\nThe project is divided into two studies. The first one is devoted to contrast the acute effect of three resistance training sessions with the same volume, intensity, length a work-to-rest ratio, but differing in set configuration. Thus, a sample of 60 postmenopausal women (30 normotensive and 30 hypotensive) will be recruited in local sport facilities in order to carry out in a randomized order three experimental sessions and a control session. Before and after each session hemodynamic (systolic, diastolic and mean blood pressure), cardiac performance (heart rate, cardiac output, stroke volume among others), cardiac and vascular autonomic modulation (hear rate and blood pressure variability), baroreflex effectiveness (baroreflex sensitivity), neuromuscular fatigue, arterial stiffness and metabolic (lactate concentrations) responses and resting energy expenditure (oxygen consumption) will be evaluated. This first analysis will allow us to identify the two set configurations with the highest and the lowest cardiovascular stress respectively, being these exercise structures used in the second study, in which the effect of 12 weeks resistance training programs differing in set configuration will be contrasted. To do this, a sample of 40 postmenopausal women will be randomly assigned to a control group and to two resistance training programs (higher and lower set configuration respectively) which be carried out throughout 12 weeks with a frequency of 2 session per week. Training loads will be readjusted every four weeks. Before and after the training programs and after a 4 weeks follow-up period the following components will be evaluated: body composition by bioimpedance, muscular thickness by echography, neuromuscular performance (isokinetic torque-velocity and power-velocity relationship), resting metabolic rate by indirect calorimetry, foot bone mineral density, beat-to-beat blood pressure by photoplethysmography, cardiac performance by impedance cardiography , cardiac autonomic modulation by heart rate variability analysis, baroreflex sensitivity analysis, sympathetic vasomotor tone (blood pressure variability) and arterial stiffness. This project will provide useful information for optimizing the resistance exercise prescription for postmenopausal women by identifying exercise structures that potentially allow to preserve physiological adaptations and at the same time to blunt the acute cardiovascular stress.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Five years since menopause\n* Physically active (150-300 minutes a week of moderate physical activity or at least 75 minutes a week of vigorous physical activity)\n* No more than 3 cardiovascular risk factors\n* Asymptomatic and without cardiovascular (except hypertension), metabolic or renal disease\n* Hypertensive women should be diagnosed with grade 1 hypertension that must be well controlled by one drug and with low or moderate cardiovascular risk.\n\nExclusion Criteria:\n\n* Having grade 2 or 3 hypertension\n* Participants with hypertension and taking more than one drug for controlling hypertension or by a drug that can interfere cardiovascular responses to exercise\n* To be or have been receiving hormonal replacement therapy\n* To show hypertensive response to exercise'}, 'identificationModule': {'nctId': 'NCT05544357', 'acronym': 'CARE', 'briefTitle': 'Cardiovascular Adaptations to Resistance Exercise: Effect of Set Configuration on Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Universidade da Coruña'}, 'officialTitle': 'Cardiovascular Adaptations to Resistance Exercise: Effects of Set Configuration on Normotensive and Hypertensive Postmenopausal Women', 'orgStudyIdInfo': {'id': 'PID2021-124277OB-I00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance training with short set configuration performed by normotensive postmenopausal women', 'description': 'Normotensive postmenopausal women performing resistance training protocol with the lowest cardiovascular stress identified in the first study of the project. It can be expected to be a short set configuration protocol', 'interventionNames': ['Other: Short set configuration resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'Resistance training with short set configuration performed by hypertensive postmenopausal women', 'description': 'Hypertensive postmenopausal women performing resistance training protocol with the lowest cardiovascular stress identified in the first study of the project. It can be expected to be a short set configuration protocol', 'interventionNames': ['Other: Short set configuration resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'Resistance training with long set configuration performed by normotensive postmenopausal women', 'description': 'Normotensive postmenopausal women performing resistance training protocol with the highest cardiovascular stress identified in the first study of the project. It can be expected to be a long set configuration protocol', 'interventionNames': ['Other: Long set configuration resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'Resistance training with long set configuration performed by hypertensive postmenopausal women', 'description': 'Hypertensive postmenopausal women performing resistance training protocol with the highest cardiovascular stress identified in the first study of the project. It can be expected to be a long set configuration protocol', 'interventionNames': ['Other: Long set configuration resistance training']}], 'interventions': [{'name': 'Short set configuration resistance training', 'type': 'OTHER', 'description': 'Resistance training protocol with the lowest cardiovascular stress identified in the first study of the project. It can be expected to be a short set configuration protocol', 'armGroupLabels': ['Resistance training with short set configuration performed by hypertensive postmenopausal women', 'Resistance training with short set configuration performed by normotensive postmenopausal women']}, {'name': 'Long set configuration resistance training', 'type': 'OTHER', 'description': 'Resistance training protocol with the highest cardiovascular stress identified in the first study of the project. It can be expected to be a short set configuration protocol', 'armGroupLabels': ['Resistance training with long set configuration performed by hypertensive postmenopausal women', 'Resistance training with long set configuration performed by normotensive postmenopausal women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15179', 'city': 'Bastiagueiro', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Faculty of Sport Sciences and Physical Education', 'geoPoint': {'lat': 43.3427, 'lon': -8.35116}}], 'overallOfficials': [{'name': 'Eliseo Iglesias-Soler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of A Coruna'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '6 months after finishing the whole project', 'ipdSharing': 'YES', 'description': 'After finishing the protocols (six months approximately) main data will be shared through European data repository Zenodo, in which University of A Coruna has created a community (https://zenodo.org/communities/udc/?page=1\\&size=20\\&size=20).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade da Coruña', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministerio de Ciencia e Innovación, Spain', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eliseo Iglesias Soler', 'investigatorAffiliation': 'Universidade da Coruña'}}}}