Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-03-11 @ 7:27 AM
Study NCT ID:
NCT03709251
Status:
TERMINATED
Last Update Posted:
2021-03-04
First Post:
2018-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Intensity Walking to Reduce Frailty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'whyStopped': 'Due to COVID-19 safety precautions and public health guidelines, the study was terminated early.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2018-10-12', 'studyFirstSubmitQcDate': '2018-10-15', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in frailty as measured by the Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI)', 'timeFrame': 'Baseline, Week 9, Month 6', 'description': 'Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI) which assesses fatigue, appetite, weakness, walking difficulties, and low physical activity'}], 'secondaryOutcomes': [{'measure': 'Improved mobility as measured by gait speed', 'timeFrame': 'Baseline, Week 9, Month 6', 'description': 'Measures related to overall health and mobility'}, {'measure': 'Improved mobility as measured by 6 Minute Walk Test', 'timeFrame': 'Baseline, Week 9, Month 6', 'description': 'Measures related to mobility'}, {'measure': 'Improved mobility as measured by Time Up and Go', 'timeFrame': 'Baseline, Week 9, Month 6', 'description': 'Measures related to mobility'}, {'measure': 'Improved physical function on the Short Physical Performance Battery', 'timeFrame': 'Baseline, Week 9, Month 6', 'description': 'Provide an overall assessment of functional status and physical performance'}, {'measure': 'Improved balance as measured by the Berg Balance Scale', 'timeFrame': 'Baseline, Week 9, Month 6', 'description': 'The Berg Balance Scale is a valid and reliable 14 item tool to evaluate static and dynamic balance among older adults. Minimum Score 0 to Maximum Score 56. • Score of \\< 45 indicates individuals may be at greater risk of falling'}, {'measure': 'Monthly self reports of Health Care Utilization', 'timeFrame': 'Baseline, Week 9, Month 3, Month 4, Month 5, Month 6', 'description': 'Monthly self-reports of number of falls, number of hospitalizations, and number of emergency room visits'}, {'measure': 'Patient Reported Outcomes Measure Information System (PROMIS) Global Health', 'timeFrame': 'Baseline, Week 9, Month 6', 'description': 'assess subjective measures of physical and mental health, pain, and quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frailty']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a physical therapist (PT) led gait training intervention for 100 older adults with pre-frailty or frailty. The goals of this study are To determine the effect of gait training intensity on frailty, mobility, physical functioning, and quality of life, as well as balance and healthcare utilization.', 'detailedDescription': 'Frailty is a leading cause of dependency among older adults, affects up to 60% of older adults, and is associated with an increased risk for falls, hospitalizations, institutionalization, and death. Exercise is the most widely recommended treatment for improving physical function among the frailty, but the optimal type or intensity of exercise is unknown. Walking is a preferred physical activity among older adults, however, there are no clear guidelines on the best intensity of walking to reduce frailty. The specific goal of this project is to compare a high intensity walking (HIW) intervention (70-80% of heart rate maximum) to a moderate intensity walking (MIW) intervention (50-60% of heart rate maximum) for pre-frail or frail older adults to determine the impact on frailty, mobility, balance, quality of life, and healthcare utilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving services from CJE SeniorLife\n* Pre-frailty or frailty as determined on the SHARE-FI.\n* Able to ambulate at least 10 feet with moderate assistance (\\<50% physical assistance) or less. Participants will be able to use their assistive device (e.g. cane or walker) during sessions.\n* \\> 65 years of age\n* Provision of informed consent and clearance for participation as determined by the Exercise and Screening for You (EASY)\n\nExclusion Criteria:\n\n* Uncontrolled cardiovascular, metabolic, renal, or respiratory disease that limits exercise participation (e.g., previous heart attack within 3 months of enrollment or uncontrolled diabetes)\n* Resting blood pressure \\> 180/110 mmHg.59'}, 'identificationModule': {'nctId': 'NCT03709251', 'briefTitle': 'High Intensity Walking to Reduce Frailty', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'High Intensity Walking to Reduce Frailty', 'orgStudyIdInfo': {'id': 'STU00205686'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Intensity Walking', 'description': 'HIW (70-80% Heart Rate max)', 'interventionNames': ['Behavioral: High Intensity Walking']}, {'type': 'EXPERIMENTAL', 'label': 'Casual Speed Walking', 'description': 'Self selected pace', 'interventionNames': ['Behavioral: Casual Speed Walking']}], 'interventions': [{'name': 'High Intensity Walking', 'type': 'BEHAVIORAL', 'description': 'Intense walking activity at an intensity of 70-80% of the maximum heart rate', 'armGroupLabels': ['High Intensity Walking']}, {'name': 'Casual Speed Walking', 'type': 'BEHAVIORAL', 'description': 'Moderate intensity (50-60% of Heart Rate maximum)', 'armGroupLabels': ['Casual Speed Walking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Margaret Danilovich', 'investigatorAffiliation': 'Northwestern University'}}}}