Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT05025202
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2021-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood Pressure and Cardiac Autonomic Adaptations to Isometric Exercise Training
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': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants in the sham intervention group were not aware they they were not performing the IET intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure (systolic, diastolic and mean BP)', 'timeFrame': 'At the start of the intervention (pre 4 week intervention)', 'description': 'Resting office blood pressure measured at brachial artery'}, {'measure': 'Blood pressure (systolic, diastolic and mean BP)', 'timeFrame': 'At the end of the intervention (post 4 weeks)', 'description': 'Resting office blood pressure measured at brachial artery'}, {'measure': 'Cardiac autonomics measured at HRV', 'timeFrame': 'At the start of the intervention (pre 4 week intervention)', 'description': 'LF and HF power spectral measures'}, {'measure': 'Cardiac autonomics measured at HRV', 'timeFrame': 'At the end of the intervention (post 4 weeks)', 'description': 'LF and HF power spectral measures'}], 'secondaryOutcomes': [{'measure': 'continuous 5-minute blood pressure (systolic, diastolic and mean BP)', 'timeFrame': 'At the start of the intervention (pre 4 week intervention)', 'description': '5 minute mean of resting blood pressure measured beat-to-beat'}, {'measure': 'continuous 5-minute blood pressure (systolic, diastolic and mean BP)', 'timeFrame': 'At the end of the intervention (post 4 weeks)', 'description': '5 minute mean of resting blood pressure measured beat-to-beat'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '35083878', 'type': 'DERIVED', 'citation': "Decaux A, Edwards JJ, Swift HT, Hurst P, Hopkins J, Wiles JD, O'Driscoll JM. Blood pressure and cardiac autonomic adaptations to isometric exercise training: A randomized sham-controlled study. Physiol Rep. 2022 Jan;10(2):e15112. doi: 10.14814/phy2.15112."}]}, 'descriptionModule': {'briefSummary': 'A randomized, sham-controlled intervention measuring the effects of isometric exercise training (IET) on blood pressure and cardiac autonomics.\n\nIET has been proven effective in a plethora of randomized trials, but very little research has employed a sham-controlled design. This researched involved the recruitment of 30 participants who completed a 4 week IET intervention, sham control of the IET intervention, or a non-intervention control period. Pre and post blood pressure and cardiac autonomic measures were acquired and analysed.\n\nThe hypothesis of this trial was a significant effect of IET on blood pressure, with no such effects following the sham control or normal control interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy with no significant health conditions contraindicating exercise\n* Over 18 years of age\n* Physically inactive\n\nExclusion Criteria:\n\n* Achieving current physical activity guidelines\n* Abnormal resting ECG\n* under 18'}, 'identificationModule': {'nctId': 'NCT05025202', 'briefTitle': 'Blood Pressure and Cardiac Autonomic Adaptations to Isometric Exercise Training', 'organization': {'class': 'OTHER', 'fullName': 'Canterbury Christ Church University'}, 'officialTitle': 'Blood Pressure and Cardiac Autonomic Adaptations to Isometric Exercise Training: a Randomised Sham-controlled Study', 'orgStudyIdInfo': {'id': '18/SAS/47C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IET', 'description': 'Participants allocated to this arm performed 4 weeks of isometric wall squat exercise training, 3 times per week.', 'interventionNames': ['Other: Isometric exercise training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Participants allocated to this arm performed 4 weeks of isometric wall squat training, but the training prescription was intentionally provided at an insufficient intensity to achieve any physiology stimulus.', 'interventionNames': ['Other: Isometric exercise training']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention control', 'description': 'Participants allocated to this arm did not perform any exercise and were required to maintain usual daily habits.'}], 'interventions': [{'name': 'Isometric exercise training', 'type': 'OTHER', 'description': 'A form of exercise involving static contraction against a wall, sustained for 2 minutes x4 sets per session. 3 sessions a week were required. The intensity was designed to achieve 95% of the participants maximum heart rate.', 'armGroupLabels': ['IET', 'Sham']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Canterbury', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Canterbury Christ Church University', 'geoPoint': {'lat': 51.27904, 'lon': 1.07992}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canterbury Christ Church University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}