Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT02746692
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2016-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Faster Back Home: Efficacy of a High-intensity Endurance Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-28', 'studyFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal ventilatory aerobic endurance capacity assessed by spiroergometry', 'timeFrame': '10 min.'}, {'measure': 'Maximal lactate aerobic endurance capacity assessed by spiroergometry', 'timeFrame': '10 min.'}], 'secondaryOutcomes': [{'measure': 'Jumping performance; counter movement jump', 'timeFrame': '1 min.'}, {'measure': 'Dynamic balance assessed with the time to stabilization test', 'timeFrame': '2 min'}, {'measure': 'Static balance assessed with the time to stabilization test', 'timeFrame': '2 min'}, {'measure': 'Maximal isometric voluntary force of the shoulder muscles', 'timeFrame': '10 min'}, {'measure': 'Maximal isometric voluntary force of the lower limb extensors', 'timeFrame': '10 min'}, {'measure': 'body composition assessed with a external non-invasive impedance device', 'timeFrame': '10 min.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Sports medical experts recommend considerable amounts of regular physical activity in order to improve strength, motor control, endurance and flexibility. However, only a small share of the population is able to meets the corresponding international guidelines. One reason for this is supposed to consist in private scheduling problems and the high time expenditure. Against this background, high-intensity intermittent training methods with short durations have become popular.\n\nThe present study aims to evaluate the effectivity of a high -intensity functional circuit training (the FIT15 program) in improving body function.\n\nThirty healthy individuals will be included in the randomized, controlled two-armed parallel group trial. In the intervention group, the participants will perform the FIT15 program, a group-based high-intensity circuit training based on functional movement patterns (e.g. squats, push-ups, burpees, jumps, rope-skipping). The training will be carried out three times a week, each 15 minutes for a total of six weeks. In the control group, the participants will exercise three times a week (in total for six weeks) at moderate intensity on an ergometer according to the cardiopulmonary exercise guidelines of the American College of Sports Medicine. Outcomes assess prior and following the six-week training period encompass body fat and muscle mass (bio impedance analysis), aerobic exercise capacity (spirometric exercise testing including lactate analysis), postural control (force plate), maximum strength of the leg extensors and shoulder muscles (1 repetition maximum) and psychometric variables (e.g. physical activity readiness questionnaire).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n* subscribing informed consent\n\nExclusion Criteria:\n\n* Drug intake in the past 48 hours\n* Pregnancy\n* Muscle soreness'}, 'identificationModule': {'nctId': 'NCT02746692', 'acronym': 'Fit15', 'briefTitle': 'Faster Back Home: Efficacy of a High-intensity Endurance Training', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'Faster Back Home: a Randomized Controlled Equivalence Study on the Efficacy of a High-intensity 15 Minute Aerobic Endurance Training', 'orgStudyIdInfo': {'id': 'SpM2016-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Other: Fit15']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison', 'interventionNames': ['Other: Endurance']}], 'interventions': [{'name': 'Fit15', 'type': 'OTHER', 'description': 'Group-based high-intensity circuit training based on functional movement patterns (e.g. squats, push-ups, burpees, jumps, ropeskipping).\n\nTotal duration 15 minutes circle training: 20s workout, 10 rest', 'armGroupLabels': ['Intervention']}, {'name': 'Endurance', 'type': 'OTHER', 'description': 'Moderate intensity ergometer training. Total duration 50 minutes', 'armGroupLabels': ['Comparison']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60487', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Department of Sports Medicine, Goethe University Frankfurt/Main', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department', 'investigatorFullName': 'Prof. Dr. Dr. Winfried Banzer', 'investigatorAffiliation': 'Goethe University'}}}}