Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2026-03-03 @ 12:37 AM
Study NCT ID:
NCT03821805
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2019-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effect of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-26', 'studyFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2019-01-26', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate variability', 'timeFrame': 'immediately following intervention phase', 'description': '15 minutes resting electrocardiographic record at baseline and post-intervention phase'}], 'secondaryOutcomes': [{'measure': 'Arterial pulse waveform', 'timeFrame': 'immediately following intervention phase', 'description': '15 minutes resting arterial plethysmographic waveform at baseline and post-intervention phase'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart rate variability', 'Arterial pulse waveform'], 'conditions': ['Massage', 'Anaerobic Exercise', 'Aerobic Exercise']}, 'descriptionModule': {'briefSummary': 'Foot reflexology treatment provides acute and chronic effects on cardiovascular and hemodynamic functions. However, no information is available to us in regarding the treatment effect of foot reflexology after exercise. This study investigated the acute effect of foot reflexology treatment on heart rate variability after anaerobic-based and aerobic-based intermittent exercises.', 'detailedDescription': 'The sympathetic activation and sympathy-vagal balance after repeat sprint performance can be immediately modulated by foot reflexology massage. The acute benefits of foot reflexology intervention on cardiac sympathovagal balance can be considered as exercise recovery strategies in sports.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undertake football/futsal training at least 3 times a week\n* Age between 18 and 30 years old\n\nExclusion Criteria:\n\n* History of severe neuromuscular injury\n* Current lower extremity injury\n* Current neurological diseases'}, 'identificationModule': {'nctId': 'NCT03821805', 'briefTitle': 'Acute Effect of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform', 'organization': {'class': 'OTHER', 'fullName': 'University of Taipei'}, 'officialTitle': 'Effects of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform After Yo Yo Intermittent Recovery Test and Repeated Sprint Test', 'orgStudyIdInfo': {'id': 'UT-IRB-2016-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foot reflexology massage group', 'description': 'The duration of intervention was 30 min (15 min massage duration for each leg)', 'interventionNames': ['Other: Foot reflexology massage']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Rest for 30 min'}], 'interventions': [{'name': 'Foot reflexology massage', 'type': 'OTHER', 'description': 'Foot reflexology technique of Father Josef was used as massage intervention', 'armGroupLabels': ['Foot reflexology massage group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data is protected by IRB application with a minimum of 3 years data storage.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Taipei', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'YUNG-SHENG CHEN', 'investigatorAffiliation': 'University of Taipei'}}}}