Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-01-07 @ 5:49 AM
Study NCT ID:
NCT05497960
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2022-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D018908', 'term': 'Muscle Weakness'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eric@teamvivo.com', 'phone': '770-331-3208', 'title': 'Eric Levitan', 'organization': 'IMPACTIV (Vivo)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 12 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Vivo Intervention', 'description': 'Participants participated via Zoom in a virtual exercise class 2 days/week for 45 minutes for 12 weeks. Exercise classes were led by a certified trainer and each class focused on building strength, flexibility, balance, and cognitive skills', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 3, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain following a skiing accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder pain following exercise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Leg Strength Assessed Through a 30 Second Chair Rise Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivo Strength Training', 'description': 'Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout.\n\nVivo workout: 2 days a week for 12 weeks of a live, interactive virtual strength training program. Each class is 45 minutes long and lead by a certified trainer.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '2.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 3 months (endpoint)', 'description': 'Participants completed as many chair stands as they could in 30 seconds', 'unitOfMeasure': 'number of chair stands', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Workout Attendance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'exercise sessions', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivo Strength Training', 'description': 'Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout.\n\nVivo workout: 2 days a week for 12 weeks of a live, interactive virtual strength training program. Each class is 45 minutes long and lead by a certified trainer.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after each workout session for up to 3 months (endpoint)', 'description': 'Attendance to each workout session was tallied. A possible 24 workout sessions were offered for the intervention (12 weeks of 2 days a week for workouts). The number of participants includes everyone who completed intervention, excluding those who stopped intervention at some point. The data reported represents the overall percent attendance of the participants that completed the intervention (N=22 participants). Attendance was calculated by averaging the number of sessions attended divided by the total number of exercise sessions attended (24 sessions).', 'unitOfMeasure': 'percent of attendance', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'exercise sessions', 'denomUnitsSelected': 'exercise sessions', 'populationDescription': '22 participants completed the intervention. Each participant had the opportunity to attend 24 exercise sessions. The attendance rate was calculated based on the number of sessions the participant attended divided by the total possible sessions (24 sessions). The attendance rate was then averaged across the participants who completed the intervention.'}, {'type': 'PRIMARY', 'title': 'Intervention Engagement Assessed by Self- Reported Ease of Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivo Strength Training', 'description': 'Vivo workout: 2 days a week for 12 weeks of a live, interactive virtual strength training program. Each class is 45 minutes long and lead by a certified trainer.'}], 'classes': [{'title': 'Easy to sign into class', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Easy to follow workout instructions during class', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Level system made it easy to tailor intensity and exercises to my abilities', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 3 months (endpoint)', 'description': 'Participants completed a questionnaire (Likert Scale) on their experience using Vivo. 1= Strong Disagree to 5= Strongly Agree', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Program Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivo Strength Training', 'description': 'Vivo workout: 2 days a week for 12 weeks of a live, interactive virtual strength training program. Each class is 45 minutes long and lead by a certified trainer.'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the 3 month (endpoint)', 'description': 'Participants completed the question on a questionnaire to answer "What was your overall satisfaction with Vivo?" Responses are percentage of participant who reported being satisfied or very satisfied with the Vivo intervention. A higher number indicates higher satisfaction.', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Exercise Intervention Trainer Fidelity Checklist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'exercise sessions', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivo Strength Training', 'description': 'Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout.\n\nVivo workout: 2 days a week for 12 weeks of a live, interactive virtual strength training program. Each class is 45 minutes long and lead by a certified trainer.'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'over the course of the 12 week intervention', 'description': 'The exercise intervention fidelity as assessed at 4 time points over the course of the 12-week exercise program using a 9-item checklist to ensure unbiased assessment. The purpose was to observe the exercise session to see if the main areas of the intervention were being delivered; workout intensity, safety, and participation and engagement. The results below indicate the percentage of exercise workouts that met the 9-item checklist. A higher score indicates higher fidelity.', 'unitOfMeasure': 'percentage of workouts meeting checklist', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'exercise sessions', 'denomUnitsSelected': 'exercise sessions', 'populationDescription': 'There were 4 exercise cohorts in this feasibility study, taught by different trainers. To ensure exercise fidelity across the cohorts, 4 exercise sessions from each cohort were observed for a total of 16 observed exercise sessions. A 9-item checklist was used to ensure components of the sessions were being met. The 16 sessions met 96% of the checklist components.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Health-related Quality of Life Measured Via the Short Form (SF)-36', 'timeFrame': 'baseline and at 3 months (endpoint)', 'description': 'Change from baseline to 3 months will be assessed (scores range from 0-100 with higher scores indicating better health-related quality of life)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Satisfaction With Life Measured by the 5 Item SWL Questionnaire', 'timeFrame': '3 months', 'description': 'Changes from baseline to 3 months (SWL scores range from 5-35 with higher score indicating greater SWL)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Profile of Mood Survey (POMS)', 'timeFrame': 'baseline and at 3 months (endpoint)', 'description': "Changes from baseline to 3 months will assess participant's changes in mood.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Perceived Stress Scale Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': 'baseline and at 3 months (endpoint)', 'description': "Changes from baseline to 3 months will assess participant's changes in perceived stress. likert scale from 0-4, higher scores indicate higher stress", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exercise Efficacy', 'timeFrame': 'baseline and at 3 months (endpoint)', 'description': "Changes from baseline to 3 months will be assessed using a questionnaire measuring the participant's confidence in completing exercise related behaviors", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sleep Measured Via the Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'baseline and at 3 months (endpoint)', 'description': 'Change from baseline to 3 months (PSQI scores range from 0-21 with higher scores indicating worse sleep quality)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vivo Intervention', 'description': 'Participants participated via Zoom in a virtual exercise class 2 days/week for 45 minutes for 12 weeks. Exercise classes were led by a certified trainer and each class focused on building strength, flexibility, balance, and cognitive skills'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Participants were recruited from electronic medical records in Duke Maestro Care as described in the Clinical Trials Information. All participants who enrolled and were eligible for the trial participated in the feasibility study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vivo Strength Training', 'description': 'Vivo workout: 2 days a week for 12 weeks of a live, interactive virtual strength training program. Each class is 45 minutes long and lead by a certified trainer.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'spread': '6.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Leg strength assessed through a 30 second chair rise test', 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'spread': '2.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'chair stands', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-26', 'size': 331777, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-13T14:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2022-08-08', 'resultsFirstSubmitDate': '2024-06-08', 'studyFirstSubmitQcDate': '2022-08-09', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-11-07', 'studyFirstPostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health-related Quality of Life Measured Via the Short Form (SF)-36', 'timeFrame': 'baseline and at 3 months (endpoint)', 'description': 'Change from baseline to 3 months will be assessed (scores range from 0-100 with higher scores indicating better health-related quality of life)'}, {'measure': 'Satisfaction With Life Measured by the 5 Item SWL Questionnaire', 'timeFrame': '3 months', 'description': 'Changes from baseline to 3 months (SWL scores range from 5-35 with higher score indicating greater SWL)'}, {'measure': 'Profile of Mood Survey (POMS)', 'timeFrame': 'baseline and at 3 months (endpoint)', 'description': "Changes from baseline to 3 months will assess participant's changes in mood."}, {'measure': 'Perceived Stress Scale Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': 'baseline and at 3 months (endpoint)', 'description': "Changes from baseline to 3 months will assess participant's changes in perceived stress. likert scale from 0-4, higher scores indicate higher stress"}, {'measure': 'Exercise Efficacy', 'timeFrame': 'baseline and at 3 months (endpoint)', 'description': "Changes from baseline to 3 months will be assessed using a questionnaire measuring the participant's confidence in completing exercise related behaviors"}, {'measure': 'Sleep Measured Via the Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'baseline and at 3 months (endpoint)', 'description': 'Change from baseline to 3 months (PSQI scores range from 0-21 with higher scores indicating worse sleep quality)'}], 'primaryOutcomes': [{'measure': 'Leg Strength Assessed Through a 30 Second Chair Rise Test', 'timeFrame': 'at 3 months (endpoint)', 'description': 'Participants completed as many chair stands as they could in 30 seconds'}, {'measure': 'Workout Attendance', 'timeFrame': 'after each workout session for up to 3 months (endpoint)', 'description': 'Attendance to each workout session was tallied. A possible 24 workout sessions were offered for the intervention (12 weeks of 2 days a week for workouts). The number of participants includes everyone who completed intervention, excluding those who stopped intervention at some point. The data reported represents the overall percent attendance of the participants that completed the intervention (N=22 participants). Attendance was calculated by averaging the number of sessions attended divided by the total number of exercise sessions attended (24 sessions).'}, {'measure': 'Intervention Engagement Assessed by Self- Reported Ease of Use', 'timeFrame': 'at 3 months (endpoint)', 'description': 'Participants completed a questionnaire (Likert Scale) on their experience using Vivo. 1= Strong Disagree to 5= Strongly Agree'}, {'measure': 'Program Satisfaction', 'timeFrame': 'at the 3 month (endpoint)', 'description': 'Participants completed the question on a questionnaire to answer "What was your overall satisfaction with Vivo?" Responses are percentage of participant who reported being satisfied or very satisfied with the Vivo intervention. A higher number indicates higher satisfaction.'}, {'measure': 'Exercise Intervention Trainer Fidelity Checklist', 'timeFrame': 'over the course of the 12 week intervention', 'description': 'The exercise intervention fidelity as assessed at 4 time points over the course of the 12-week exercise program using a 9-item checklist to ensure unbiased assessment. The purpose was to observe the exercise session to see if the main areas of the intervention were being delivered; workout intensity, safety, and participation and engagement. The results below indicate the percentage of exercise workouts that met the 9-item checklist. A higher score indicates higher fidelity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['older adults', 'pre diabetes', 'strength training', 'muscle weakness', 'resistance training', 'virtual', 'intervention'], 'conditions': ['PreDiabetes', 'Older Adults', 'Muscle Loss', 'Muscle Weakness']}, 'descriptionModule': {'briefSummary': 'This research trial studies the effect of an online, live and interactive strength training program on physical function and strength in older adults with prediabetes.', 'detailedDescription': 'It is well established that in-person resistance training is an effective form of exercise to increase physical function and quality of life amongst adults. However, older adults report not participating in resistance training due to lack of age appropriate programs, fear of a gym setting, poor access to a gym, joint and other kinds of pain, and lack of social support. These barriers have been compounded as a result of COVID-19 pandemic, wherein older adults are encouraged to socially isolate, leading to even less physical activity. Vivo is a virtual small group exercise program designed for adults 55 and addresses these major barriers to strength training by coaching through an interactive online training session incorporating social support and social engagement.\n\nThe investigators plan is to test a highly attractive technology platform specifically designed to meet the needs of older adults to demonstrate that resistance training exercise can be scaled and effective with diverse older adults and remove the barrier of having to go to a gym setting to see benefits. The investigators will test feasibility in a real world sample of adults ≥60 with prediabetes, a very prevalent, serious and often silent health condition that affects 1 in 3 adults in the US and is associated with high rates of sarcopenia, or loss of muscle mass.\n\nIn the next study, Phase II NCT06458530, investigators will examine the effects of Vivo on physical function and glycemic level in sedentary older with prediabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 60 years;\n\n * Diagnosis of Pre-diabetes within prior 12 months: fasting glucose between 100 to 126 OR HbA1c between 5.7 and 6.4%\n * Ambulatory and community-dwelling\n * Sedentary: less than 150 minutes of moderate physical activity OR less than 75 minutes of vigorous physical activity per week\n * Have not engaged in resistance training for at least 6 months prior to enrollment\n * Low functioning (defined as able to do at least 1 chair stand without using hand in 30 second but unable to meet the moderate function criteria for age and gender)\n * Access to WiFi (or internet connection) in defined exercise space\n * Willing to maintain weight and current diet throughout the study\n\nExclusion Criteria:\n\n* Inability to complete physical function assessment or inability to do a chair stand without using hands.\n* Use of antidiabetic medications\n* Use of testosterone supplement or replacement\n* Clinical disorder precluding/interfering with participation or assessments\n\n * Unstable angina, arrhythmia, uncontrolled hypertension\n * End Stage Renal Disease on Hemodialysis\n * Lower extremity amputation or paralysis\n * Neurological conditions causing functional or pronounced cognitive impairments\n * Active malignancy except for non-melanomatous skin cancers\n* Unable to provide consent\n* Weight instability'}, 'identificationModule': {'nctId': 'NCT05497960', 'briefTitle': 'Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Impactiv, Inc.'}, 'officialTitle': 'Evaluating the Feasibility and Acceptability of Vivo, an Online, Live and Interactive Strength Training Program, in Sedentary Older Adults With Prediabetes.', 'orgStudyIdInfo': {'id': 'Pro00110021'}, 'secondaryIdInfos': [{'id': '1R44AG076087-01', 'link': 'https://reporter.nih.gov/quickSearch/1R44AG076087-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Vivo strength training', 'description': 'Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout.', 'interventionNames': ['Behavioral: Vivo workout']}], 'interventions': [{'name': 'Vivo workout', 'type': 'BEHAVIORAL', 'description': '2 days a week for 12 weeks of a live, interactive virtual strength training program. Each class is 45 minutes long and lead by a certified trainer.', 'armGroupLabels': ['Vivo strength training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eric Levian', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'CEO', 'investigatorFullName': 'Eric Levian', 'investigatorAffiliation': 'Impactiv, Inc.'}}}}