Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-01-09 @ 6:58 PM
Study NCT ID:
NCT04932733
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2021-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isometric Exercises in Healthy Elderly Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-09', 'studyFirstSubmitDate': '2021-06-06', 'studyFirstSubmitQcDate': '2021-06-12', 'lastUpdatePostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure (BP)', 'timeFrame': 'Change from baseline blood pressure at 1 day', 'description': 'Both systolic and diastolic blood pressures were measured by a trained physiotherapist in the right upper arm using an appropriate-sized cuff at the baseline and the end of the intervention using an automated Dinamap MPS Select device (Johnson \\& Johnson, New Brunswick, NJ).'}], 'secondaryOutcomes': [{'measure': 'Respiratory Rate (RR)', 'timeFrame': 'Change from baseline respiratory rate at 1 day', 'description': 'Respiratory rate was assessed by visually observe for 30 seconds and multiply observed breaths by 2 to obtain breaths per minute (BPM).'}, {'measure': 'Oxygen Saturation (SaO2)', 'timeFrame': 'Change from baseline oxygen saturation at 1 day', 'description': 'Oxygen saturation was recorded using a finger pulse oximeter. The sensor was placed on the right index finger, and the values were recorded after at least two minutes.'}, {'measure': 'Heart Rate (HR)', 'timeFrame': 'Change from baseline heart rate at 1 day', 'description': 'Heart rate was recorded using a finger pulse oximeter. The sensor was placed on the right index finger, and the values were recorded after at least two minutes.'}, {'measure': 'Mean Arterial Pressure (MAP)', 'timeFrame': 'Change from baseline mean arterial pressure at 1 day', 'description': 'Mean arterial pressure was calculated MAP as diastolic blood pressure (DBP) + 1/3 \\[systolic blood pressure (SBP) - DBP\\].'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood pressure', 'Isometric exercise'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A total of 58 participants were selected and divided into two groups equally, namely, elderly, and young groups with the age groups of 60-80 years and 20-30 years, respectively. The Heart Rate (HR), Respiratory Rate (RR), Blood Pressure (BP), Oxygen Saturation (SaO2), and Mean Arterial Pressure (MAP) for each participant were assessed before and after the treatment session.', 'detailedDescription': 'The elderly participants in the experimental group and the young participants in the control group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take rest of 10 minutes before performing the exercise. After that, the exercise was performed from a long-sitting position.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria were normotensive males and females in the above age groups.\n\nExclusion Criteria:\n\n* Participants with a chronic history of alcohol, smoking, resting tachycardia (\\>100 beats per min), hypertension, history of any other cardiovascular disorders, any peripheral vascular disease, those on a regular exercise program, and uncooperative participants.'}, 'identificationModule': {'nctId': 'NCT04932733', 'briefTitle': 'Isometric Exercises in Healthy Elderly Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Isra University, Jordan'}, 'officialTitle': 'Effects of a Single Session of Knee Isometric Exercises on Blood Pressure in Healthy Elderly: A Clinical Controlled Trial', 'orgStudyIdInfo': {'id': '337-1/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elderly isometric exercise', 'description': 'Quadriceps isometric exercise.', 'interventionNames': ['Other: Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Young isometric exercise', 'description': 'Quadriceps isometric exercise.', 'interventionNames': ['Other: Young isometric exercise']}], 'interventions': [{'name': 'Exercises', 'type': 'OTHER', 'otherNames': ['Elderly isometric exercise'], 'description': 'The elderly participants in the experimental group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take a rest of 10 minutes before performing the exercise. After that, the exercise was performed from a long-sitting position.', 'armGroupLabels': ['Elderly isometric exercise']}, {'name': 'Young isometric exercise', 'type': 'OTHER', 'description': 'The young participants in the experimental group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take a rest of 10 minutes before performing the exercise. After that, the exercise was performed from a long-sitting position.', 'armGroupLabels': ['Young isometric exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11622', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Isra University', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Salameh Aldaja, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isra University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salameh Aldaja', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Salameh Aldaja', 'investigatorAffiliation': 'Isra University, Jordan'}}}}