Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-29 @ 5:58 AM
Study NCT ID:
NCT03095534
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2017-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translating 3-Step Workout for Life in a Local Senior Living Community
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group with pretest and posttest'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-03-23', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Montreal Cognitive Assessment', 'timeFrame': '12 weeks', 'description': 'Global cognitive function measure'}, {'measure': 'Patient Health Questionnaire (PHQ-9 )', 'timeFrame': '12 weeks', 'description': 'To measure the degree of depression'}, {'measure': 'A Three-Item Scale Assessing Pain Intensity and Interference (PEG)', 'timeFrame': '12 weeks', 'description': 'To measure the degree of pain and interfering with enjoyment of life and genera activities'}, {'measure': 'UCLA Loneliness Scale', 'timeFrame': '12 weeks', 'description': 'To measure the degree of loneliness'}, {'measure': 'Pearlin Mastery Scale', 'timeFrame': '12 weeks', 'description': 'To measure personal mastery'}], 'primaryOutcomes': [{'measure': 'Assessment of Motor and Process Skills (AMPS)-the motor skill scale', 'timeFrame': '12 weeks', 'description': 'To measure motor ability required to competently complete daily activities'}], 'secondaryOutcomes': [{'measure': 'Box and Block Test', 'timeFrame': '12 weeks', 'description': 'To measure motor coordination of the upper extremity'}, {'measure': 'Timed Up and Go', 'timeFrame': '12 weeks', 'description': 'To measure functional mobility'}, {'measure': '30-second arm curl test', 'timeFrame': '12 weeks', 'description': 'To measure muscle strength of the upper extremity'}, {'measure': '30-second chair stand test', 'timeFrame': '12 weeks', 'description': 'To measure muscle strength of the lower extremity'}, {'measure': 'Canadian Occupational Performance Measure', 'timeFrame': '12 weeks', 'description': 'To measure self-perception of performance in everyday living'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Occupational Therapy', 'Aging in place', 'Activities of daily living', 'Community program'], 'conditions': ['Frail Elderly', 'Muscle Weakness']}, 'referencesModule': {'references': [{'pmid': '26583695', 'type': 'BACKGROUND', 'citation': 'Liu CJ, Jones LY, Formyduval A RM, Clark DO. Task-Oriented Exercise to Reduce Activities of Daily Living Disability in Vulnerable Older Adults: A Feasibility Study of the 3-Step Workout for Life. J Aging Phys Act. 2016 Jul;24(3):384-92. doi: 10.1123/japa.2015-0070. Epub 2015 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates the feasibility of a staff-lead workout program, 3-Step Workout for Life, in a local senior living community. Eligible participants will complete assessments before and after the workout program.', 'detailedDescription': 'The 3-Step Workout for Life program is designed to help older adults improve muscle strength and apply the improved muscle strength to perform activities of daily living. The 10-week workout consists of single-joint resistance exercise, multiple-joint resistance exercise, and activities of daily living exercise. Participants will exercise in small groups in a community room as well as one-on-one with the fitness staff in their home. The community fitness staff will learn the 3-Step Workout for Life program from the University partner and deliver the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged 60 years old and above\n2. Residents of the local study community\n3. Communicable in English\n4. Took more than 16 seconds to complete five chair stands with arms crossed at the chest.\n5. Self-reported difficulty in performing one or more activities of daily living, which must include difficulty in feeding/eating, dressing, grooming/personal hygiene, bathing/showering, using the toilet, or functional mobility/transfer.\n\nExclusion Criteria:\n\n1. Aged above 90 years old.\n2. Unwilling to commit to the study program 3 sessions per week for 10 weeks.\n3. Plan to move away from the current community in 6 months.\n4. Having three or more errors on a six-item cognitive impairment screener.\n5. Having any terminal illness, cardiovascular, neurological, psychiatric, orthopedic, or cognitive impairments that are contraindications to participating in an exercise program.\n6. The difficulty of performing activities of daily living is due to neurological disorders (e.g., stroke, Parkinson's), orthopedic conditions (e.g, amputees), or sensory deficits (diabetic palsy, low vision).\n7. Physician's recommendation of no moderate physical exercise.\n8. Receiving home health rehabilitation therapy or exercise at moderate intensity for more than twice a week (last more than 20 minutes each time)."}, 'identificationModule': {'nctId': 'NCT03095534', 'briefTitle': 'Translating 3-Step Workout for Life in a Local Senior Living Community', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Translating 3-Step Workout for Life in a Local Senior Living Community: A Feasibility Study', 'orgStudyIdInfo': {'id': '1609528804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3-Step Workout for Life', 'description': 'Participants will exercise at the moderate intensity three times a week for 10 weeks. The total of 30 workout sessions will consist of 18 sessions of group single-joint resistance exercise, 6 sessions of one-on-one multiple-joint resistance exercise, and 6 sessions of one-on-one activities of daily living exercise. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and lower extremity. During the activities of daily living exercise, participants will practice daily tasks around the home. The community fitness staff will modify the task demand to increase the physical challenge of the task to each participant, for example, increasing travel distance.', 'interventionNames': ['Behavioral: 3-Step Workout for Life']}], 'interventions': [{'name': '3-Step Workout for Life', 'type': 'BEHAVIORAL', 'description': 'a 10-week moderate exercise program', 'armGroupLabels': ['3-Step Workout for Life']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University (IUPUI Campus)', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Chiung-ju Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Health & Rehabilitation Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Liu, Chiung-ju (CJ)', 'investigatorAffiliation': 'Indiana University'}}}}