Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 6:59 PM
Study NCT ID:
NCT06976060
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2025-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Intensity Interval Training in a Community Gym
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-minute Step Test Performance', 'timeFrame': 'Baseline and weekly over the 9 week intervention', 'description': 'Cardiovascular endurance metric, number of repetitions a single leg is able to complete in 2 minutes.'}], 'secondaryOutcomes': [{'measure': 'Functional Gait Asssessment', 'timeFrame': 'Baseline and weekly over the 9 week intervention', 'description': 'Balance metric, reporting the score out of 30 points'}, {'measure': '5 times sit to stand', 'timeFrame': 'Baseline and weekly over the 9 week intervention', 'description': 'Lower extremity muscular strength. Recording the amount of time to complete 5 sit to stand repetitions.'}, {'measure': 'Grip Strength', 'timeFrame': 'Baseline and weekly over the 9 week intervention', 'description': 'Upper Extremity Strength assessment. Peak grip strength measured with hand held dynamometer.'}, {'measure': 'Muscle Thickness', 'timeFrame': 'Baseline and weekly over the 9 week intervention', 'description': 'Muscle thickness will be recorded via ultrasound'}, {'measure': 'Muscle Echo Intensity', 'timeFrame': 'Baseline and weekly over the 9 week intervention', 'description': 'Ultrasound images of the vastus lateralis will be obtained and echo intensity for the muscle will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high-intensity interval training', 'older adults'], 'conditions': ['Age-related Strength Loss']}, 'descriptionModule': {'briefSummary': 'This study will deliver a 9 week high intensity interval training (HIIT) class using functional movements within a community based gym. The class will be twice a week. Outcomes are focused on cardiovascular endurance, balance, strength and muscle size and muscle quality changes. The outcomes will be assessed weekly.', 'detailedDescription': 'We will measure cardiovascular endurance (2-minute Step Test; 2MST), balance (Functional Gait Assessment; FGA), muscular strength (Grip Strength and 5 times sit-to-stand; 5xSTS) and muscle size (thickness) and quality (echo intensity) on a weekly basis over the 9 week HIIT class.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no contraindications to exercise (PAR-Q+)\n* do not have severe mental impairment (\\>14 on the SAGE)\n* ability to walk 100 ft without the use of an assistive device'}, 'identificationModule': {'nctId': 'NCT06976060', 'briefTitle': 'High-Intensity Interval Training in a Community Gym', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': 'High-Intensity Interval Training in a Community Gym', 'orgStudyIdInfo': {'id': '2005507'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-Intensity Interval Training', 'interventionNames': ['Behavioral: High-Intensity Interval Training']}], 'interventions': [{'name': 'High-Intensity Interval Training', 'type': 'BEHAVIORAL', 'description': 'High-intensity interval training (HIIT) sessions will occur twice per week, on non-consecutive days. Each training session will last 45-60 minutes and consist of eight functional movement exercises incorporating the entire body (upper body, lower body, core/stability, cycling, and agility). Participants will complete two rounds of the 8-exercise circuit with 2-minutes of rest between rounds. The load/resistance used for each exercise will be self-selected by the participants that equates to 15-18 on the RPE scale. During each round, participants will have 1 minute to complete as many repetitions as possible of a given exercise and then have 1 minute of rest before completing the next exercise - giving the participants a 1:1 exercise-to-rest ratio.', 'armGroupLabels': ['High-Intensity Interval Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'UNMC Engage Wellness Medical Fitness Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}