Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-17 @ 11:10 PM
Study NCT ID:
NCT02337803
Status:
WITHDRAWN
Last Update Posted:
2017-10-13
First Post:
2015-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Band Together: Randomized Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'A similar study was funded by PCORI so PI decided to not begin this study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2015-01-08', 'studyFirstSubmitQcDate': '2015-01-08', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Reported Outcomes Measurement Information System (PROMIS)', 'timeFrame': '12 weeks', 'description': 'survey'}, {'measure': 'National Health Interview Surveys', 'timeFrame': '12 weeks', 'description': 'survey'}, {'measure': 'Physical Activity Scale for the Elderly (PASE)', 'timeFrame': '12 weeks', 'description': 'survey'}, {'measure': 'Cognitive Impairment Questionnaire', 'timeFrame': '12 weeks', 'description': 'survey'}], 'primaryOutcomes': [{'measure': 'One Repetition Maximum', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Bow and Arrow Strength Test', 'timeFrame': '12 weeks'}, {'measure': 'Hand Grip Test', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physical Activity'], 'conditions': ['Age 65 and Older', 'Strength Training']}, 'descriptionModule': {'briefSummary': 'The study will aim to determine the effectiveness of a strength training program using resistance bands to increase strength in adults ≥65 years old', 'detailedDescription': 'Older adults in the US are in a difficult situation that is historically unprecedented. People born in 1930 were expected to live to age 59, yet they will live to an average age of 79. These dramatic survival increases, due to immunizations, antibiotics and other innovations \\[Centers for Disease, 2011\\], have occurred at the same time as dramatic reductions in daily energy expenditures, due to automobiles, washing machines and other labor-saving devices \\[Archer, 2013\\]. This has left adults living longer, yet weaker, less fit and more obese. In fact, most residents of nursing homes are not there because of dementia. Only 40% of long-term care facility residents in 2010 were diagnosed with dementia \\[Caffrey, 2012\\] and many of whom had a level of dementia which would not require nursing home placement by itself. Most residents of long-term care facilities, rather, are there because they lack the strength and fitness to care for themselves. As baby boomers retire, these factors are anticipated to greatly increase the need for long-term care, highlighted in a report from a Deloitte Consulting in 2010: "Medicaid Long-term Care: The ticking time bomb" \\[Keckley, 2010\\]. This pilot study will measure a significant increase in strength with the use of a 12 week strength training program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Fluently read and speak English\n* Willing to drive 3 times a week to Hershey Medical Center for most weeks\n* Have a primary care physician\n* Currently exercise ≤60 min per week\n\nExclusion Criteria:\n\n* Doctor has said you have a heart condition and should only do physical activity recommended by doctor\n* Feel pain in chest when doing physical activity\n* Unable to obtain doctor's consent\n* Currently participating in an exercise program\n* Plans to move in the next 6 months\n* Weight \\> 250\n* Currently exercise ≥60 min per week"}, 'identificationModule': {'nctId': 'NCT02337803', 'briefTitle': 'Band Together: Randomized Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Band Together: Randomized Control Trial', 'orgStudyIdInfo': {'id': 'IRB1056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Strength Training Group', 'description': 'Participants will meet three times a week for one hour strength training sessions for twelve weeks.', 'interventionNames': ['Behavioral: Strength Training Program', 'Behavioral: Usual Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Participants will be given access to the strength training program after the twelve week study ends.', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Strength Training Program', 'type': 'BEHAVIORAL', 'description': 'The strength training program consists of 6 exercises using resistance bands three times a week', 'armGroupLabels': ['Strength Training Group']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'Will continue daily physical activity and complete surveys online', 'armGroupLabels': ['Strength Training Group', 'Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State College of Medicine, Penn State Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Christopher Sciamanna, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Public Health Sciences; Division Chief of General Internal Medicine', 'investigatorFullName': 'Christopher Sciamanna, MD, MPH', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}