Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:27 AM
Study NCT ID:
NCT07448818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic and Isometric Strength Training in Older Adults With Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Proportion of enrolled participants relative to the total number of eligible individuals contacted. Reported as a percentage.'}, {'measure': 'Adherence to training sessions', 'timeFrame': 'During 6 weeks', 'description': 'Percentage of completed training sessions relative to the total number of planned sessions over the 6-week intervention period.'}, {'measure': 'Retention rate', 'timeFrame': 'During 6 weeks', 'description': 'Proportion of participants who complete the full 6-week intervention'}, {'measure': 'Fidelity to exercise protocol', 'timeFrame': 'Duiring 6 weeks', 'description': 'Percentage of exercises performed according to the prescribed protocol parameters, including load, repetitions, and time under tension.'}, {'measure': 'Acceptability of the intervention', 'timeFrame': 'During 6 weeks', 'description': 'Acceptability assessed through a structured satisfaction questionnaire, scored from 0 to 10, administered at the end of the 6-week intervention'}, {'measure': 'Occurrence of adverse events', 'timeFrame': 'During 6 weeks', 'description': 'Number of intervention-related adverse events, classified as mild, moderate, or severe'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Clinical resting blood pressure at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Systolic and diastolic blood pressure measured with automatic device (HEM-742, Omron Healthcare, Japan) in seated position, average of last two of three readings, in millimeters of mercury.'}, {'measure': 'Change from baseline in Home blood pressure monitoring at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Seven-day home monitoring with automatic device (Omron Healthcare, Japan), two readings morning and evening in duplicate; average of valid readings, in millimeters of mercury'}, {'measure': 'Change from baseline in Flow-mediated dilation at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Brachial and femoral artery vasodilation assessed by ultrasonography with spectral Doppler (Cannon Xario, Japan); calculated as percentage change from baseline'}, {'measure': 'Change from baseline in Standard deviation of normal R-R intervals at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Standard deviation of normal R-R intervals will be assessed using the Polar V800 heart rate monitor (Polar Electro, Finland) and expressed in milliseconds (ms).'}, {'measure': 'Change from baseline in Arterial stiffness at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Carotid-femoral pulse wave velocity measured by applanation tonometry (SphygmoCor, AtCor Medical, Australia), calculated as distance/time in meters per second'}, {'measure': 'Change from baseline in Depressive symptoms at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Geriatric Depression Scale (GDS-15), 15 items, scored 0-15, higher score = worse symptoms'}, {'measure': 'Change from baseline in Anxiety symptoms at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Generalized Anxiety Disorder questionnaire (GAD-7), 7 items, scored 0-21, higher score = worse symptoms'}, {'measure': 'Change from baseline in Six-Minute Walk Test distance at 6 weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Distance walked in meters during the six-minute walk test performed in a 30-meter corridor.'}, {'measure': 'Change from baseline in Root mean square of successive differences between R-R intervals at 6 weeks', 'timeFrame': 'Baseline to 6 weeks', 'description': 'Root mean square of successive differences between R-R intervals will be measured using the Polar V800 heart rate monitor (Polar Electro, Finland) and expressed in milliseconds (ms).'}, {'measure': 'Change from baseline in Proportion of successive R-R intervals differing by more than 50 milliseconds at 6 weeks', 'timeFrame': 'Baseline to 6 weeks.', 'description': 'Proportion of successive R-R intervals differing by more than 50 milliseconds will be measured using the Polar V800 heart rate monitor (Polar Electro, Finland) and expressed in milliseconds (ms).'}, {'measure': 'Change from baseline in Low-frequency spectral power at 6 weeks', 'timeFrame': 'Baseline to 6 weeks.', 'description': 'Low-frequency spectral power will be assessed using the Polar V800 (Polar Electro, Finland) and expressed in ms².'}, {'measure': 'Change from baseline in high-frequency power at 6 weeks', 'timeFrame': 'Baseline to 6 weeks.', 'description': 'high-frequency power High-frequency component measured with Polar V800 (Polar Electro, Finland), expressed in ms².'}, {'measure': 'Change from baseline in Low-frequency to high-frequency ratio at 6 weeks', 'timeFrame': 'Baseline to 6 weeks.', 'description': 'Low-frequency to high-frequency ratio measured with Polar V800 (Polar Electro, Finland).'}, {'measure': 'Change from baseline in Timed Up and Go Time at 6 weeks', 'timeFrame': 'Baseline and 6 weeks.', 'description': 'time in seconds to stand from a chair, walk 3 meters, turn, return, and sit down.'}, {'measure': 'Change from baseline in 30-second Chair stand repetitions at 6 weeks', 'timeFrame': 'Baseline and 6 weeks.', 'description': 'number of full stands from a seated position completed in 30seconds.'}, {'measure': 'Change from baseline in handgrip strength at 6 weeks', 'timeFrame': 'Baseline and 6 weeks.', 'description': 'maximum voluntary isometric handgrip strength measured using handheld dynamometer instrutherm DM-90 (Brazil), expressed in kilogram-force (kgf).'}, {'measure': 'Change from baseline in isometric knee extensor strength at 6 weeks', 'timeFrame': 'Baseline and 6 weeks.', 'description': 'Maximum isometric knee extensor strength measured at 90º knee angle using horizontal leg press, expressed in kilogram-force (kgf).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Strength training', 'Resistance training', 'Cardiovascular health', 'blood pressure', 'old age'], 'conditions': ['Hypertension', 'Elderly (People Aged 65 or More)']}, 'descriptionModule': {'briefSummary': 'This feasibility study aims to evaluate the effects of dynamic strength training and isometric strength training on cardiovascular health indicators, mental health, and neuromuscular fitness in older adults with hypertension. Participants will be randomly assigned to one of the two training modalities and will complete supervised exercise sessions throughout the intervention period. The study will provide preliminary evidence regarding the safety, acceptability, and potential impact of each training modality on health outcomes in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosis of arterial hypertension and currently taking antihypertensive medication\n* Age 60 years or older\n* Resting blood pressure below 160/95 mmHg\n* No high cardiovascular risk according to the American College of Sports Medicine criteria (for participants with type 2 diabetes, glycemic control with fasting glucose \\<100 mg/dL and postprandial glucose \\<140 mg/dL)\n* Not participating in a structured exercise program for more than three months\n* No cognitive or functional limitations that prevent participation in the exercise program\n\nExclusion Criteria\n\n* Presence of acute illnesses, such as influenza, sinusitis, gastroenteritis, urinary tract infection, fever, inflammatory processes, or any clinical condition requiring rest or that may compromise safety during assessments or training.\n* Decompensated clinical conditions, including: Blood pressure spikes, Chest pain, Uncontrolled arrhythmias, Shortness of breath at rest, Asthma exacerbations, Decompensated diabetes mellitus, characterized by Persistently elevated blood glucose levels (fasting glucose \\> 180 mg/dL or postprandial glucose \\> 250 mg/dL)\n* Irregular use of medication\n* Any unstable clinical condition or condition that represents additional risk for the practice of physical exercise.'}, 'identificationModule': {'nctId': 'NCT07448818', 'acronym': 'Dynamic and Is', 'briefTitle': 'Dynamic and Isometric Strength Training in Older Adults With Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'Effects of Dynamic Strength Training and Isometric Strength Training on Cardiovascular Health Indicators, Mental Health, and Neuromuscular Fitness in Older Adults With Hypertension: A Feasibility Study', 'orgStudyIdInfo': {'id': 'DYNISO-HT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dynamic Strength Training', 'description': 'The subjects randomized to this group will perform two supervised dynamic strength training sessions per week for 6 weeks, each session lasting approximately 30 minutes.', 'interventionNames': ['Behavioral: Dynamic Strength Training']}, {'type': 'EXPERIMENTAL', 'label': 'Isometric Strength Training', 'description': 'The subjects randomized to this group will perform two supervised isometric strength training sessions per week for 6 weeks, each session lasting approximately 30 minutes.', 'interventionNames': ['Behavioral: Isometric Strength Training']}, {'type': 'OTHER', 'label': 'Control', 'description': 'No supervised training will be provided. Participants in this group will not receive any exercise intervention during the 6-week study period, but they will be stimulated to be active.', 'interventionNames': ['Behavioral: No supervised intervention Control']}], 'interventions': [{'name': 'Dynamic Strength Training', 'type': 'BEHAVIORAL', 'description': 'The experimental group will perform dynamic strength exercises targeting major muscle groups, progressing in intensity and volume over the 6 weeks. Exercises include 8 major muscle group movements, initially 2 sets of 15 repetitions (Borg 4-6), progressing to 3 sets of 10 repetitions (Borg 5-7) from week 5. Participants will also be advised to perform non-supervised walking 3-5 times per week for \\~30 minutes at moderate intensity.', 'armGroupLabels': ['Dynamic Strength Training']}, {'name': 'Isometric Strength Training', 'type': 'BEHAVIORAL', 'description': 'The experimental group will perform isometric strength exercises targeting major muscle groups, progressing in intensity and volume over the 6 weeks. Exercises include 8 major muscle group contractions, initially 2 sets of 60 seconds (Borg 4-6), progressing to 3 sets of 40 seconds (Borg 5-7) from week 5. Participants will also be advised to perform non-supervised walking 3-5 times per week for \\~30 minutes at moderate intensity.', 'armGroupLabels': ['Isometric Strength Training']}, {'name': 'No supervised intervention Control', 'type': 'BEHAVIORAL', 'description': 'This group serves as a control and will not perform any structured exercise program.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Adão Luis Monte L Monte, Ms', 'role': 'CONTACT', 'email': 'adaoluiz8@outlook.com', 'phone': '+55 11 94666 5213'}, {'name': 'Raphael M Ritti-Dias, PhD', 'role': 'CONTACT', 'email': 'raphaelritti@gmail.com', 'phone': '+5519999406878'}], 'overallOfficials': [{'name': 'Raphael M Ritti-Dias, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Nove de Julho'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be shared adter the publication of the main trial', 'ipdSharing': 'YES', 'description': 'Data will be anonymized and shared after the completion of the study and publication of the main results', 'accessCriteria': 'Will be avaliable in open repositories'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Raphael Mendes Ritti Dias', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Raphael Mendes Ritti Dias', 'investigatorAffiliation': 'University of Nove de Julho'}}}}