Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-11 @ 3:24 PM
Study NCT ID:
NCT02203656
Status:
COMPLETED
Last Update Posted:
2019-04-04
First Post:
2014-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D013739', 'term': 'Testosterone'}, {'id': 'C004648', 'term': 'testosterone enanthate'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2014-05-22', 'studyFirstSubmitQcDate': '2014-07-28', 'lastUpdatePostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Follow-up Measures', 'timeFrame': '1 year post discharge', 'description': 'Rehospitalization: date of rehospitalization, duration, and discharge diagnosis Death: date of death'}], 'primaryOutcomes': [{'measure': 'Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score', 'timeFrame': 'at pre-testing, 1-week post discharge and 4-week post discharge', 'description': 'Changes in SPPB score'}], 'secondaryOutcomes': [{'measure': 'Body Composition', 'timeFrame': 'at pre-testing, 1-week post discharge and 4-week post discharge', 'description': 'Body composition will be measured using a bioimpedance scale. Changes in weight and % body fat will be calculated over the duration of the intervention.'}, {'measure': 'Hand grip strength (kg)', 'timeFrame': 'at pre-testing, 1-week post discharge and 4-week post discharge', 'description': 'Changes in hand grip will be calculated over duration of study.'}, {'measure': 'ADLS, IADLS', 'timeFrame': 'at pre-testing, 1-week post discharge and 4-week post discharge', 'description': 'Changes in Instrumental activities of daily living (IADLS), and Activities of daily living (ADLS) will be measured over the duration of the intervention.'}, {'measure': 'Physical Activity Levels', 'timeFrame': 'at pre-testing, 1-week post discharge and 4-week post discharge', 'description': 'Physical activity levels will be measured using a step activity monitor and actiwatch'}, {'measure': 'Gait Speed (m/s)', 'timeFrame': 'at pre-testing, 1-week post discharge and 4-week post discharge', 'description': 'Changes in gait speed will be calculated over duration of study.'}, {'measure': 'Blood Measures', 'timeFrame': 'at pre-testing, 1-week post discharge and 4-week post discharge', 'description': 'microRNA levels in blood will be measured'}, {'measure': '30 day re-hospitalization', 'timeFrame': '30 days post-discharge', 'description': 're-hospitalization rates will be collected'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intervention studies', 'nutrition', 'exercise', 'testosterone', 'patient readmission'], 'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '27178766', 'type': 'BACKGROUND', 'citation': 'Deer RR, Dickinson JM, Fisher SR, Ju H, Volpi E. Identifying effective and feasible interventions to accelerate functional recovery from hospitalization in older adults: A randomized controlled pilot trial. Contemp Clin Trials. 2016 Jul;49:6-14. doi: 10.1016/j.cct.2016.05.001. Epub 2016 May 10.'}, {'pmid': '28591764', 'type': 'RESULT', 'citation': 'Deer RR, Goodlett SM, Fisher SR, Baillargeon J, Dickinson JM, Raji M, Volpi E. A Randomized Controlled Pilot Trial of Interventions to Improve Functional Recovery After Hospitalization in Older Adults: Feasibility and Adherence. J Gerontol A Biol Sci Med Sci. 2018 Jan 16;73(2):187-193. doi: 10.1093/gerona/glx111.'}, {'pmid': '30906944', 'type': 'RESULT', 'citation': 'Deer RR, Dickinson JM, Baillargeon J, Fisher SR, Raji M, Volpi E. A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients. J Gerontol A Biol Sci Med Sci. 2019 Sep 15;74(10):1628-1636. doi: 10.1093/gerona/glz084.'}, {'pmid': '37251511', 'type': 'DERIVED', 'citation': 'Arentson-Lantz EJ, Deer RR, Kokonda M, Wen CL, Pecha TA, Carreon SA, Ngyen TM, Volpi E, Nowakowski S. Improvements in sleep quality and fatigue are associated with improvements in functional recovery following hospitalization in older adults. Front Sleep. 2022;1:1011930. doi: 10.3389/frsle.2022.1011930. Epub 2022 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the feasibility of interventions to accelerate recovery of muscle mass and function in older adults following acute hospitalization.', 'detailedDescription': 'The purpose of this study is to test the feasibility of interventions to accelerate recovery of muscle mass and function in older adults following acute hospitalization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to the University of Texas Medical Branch (UTMB) ACE unit with an admitting diagnosis of congestive heart failure, respiratory infection, kidney/urinary tract infection, or metabolic disorder; or other condition that will allow a subject to participate in the study after patient review\n* Aged 65 years or older\n* Self-reported ability (with or without the aid of an assistive device) to walk across a small room two weeks prior to hospitalization\n* Lives within 30 miles of UTMB\n* Can stand without assistance at the time of pretesting\n* Presents no medical contraindication to wearing a loose fitting velcro strap for the accelerometer on one ankle\n* Score ≥26 on the 30-item Mini Mental State Examination or alert and oriented X3 by physician on H\\&P\n* Is discharged "to home" at ACE unit discharge.\n\nExclusion Criteria:\n\n* Nursing home resident or hospice patient\n* Uncontrolled blood pressure (systolic \\>150, or diastolic \\> 100)\n* History of stroke with motor disability\n* Glomerular filtration rate (GFR) \\<30 mL/min/1.73m2 or evidence of kidney disease or failure\n* Liver disease ( aspartate aminotransferase (AST) /Alanine transaminase (ALT) 2 times above the normal limit, hyperbilirubinemia)\n* Recent (within 3 months) treatment with anabolic steroids\n* Any other condition or event considered exclusionary by the PI and faculty physician\n* Planned or elective hospitalization within 30 days of discharge\n\nAdditional Exclusion Criteria for Subjects Randomized to the Testosterone Group\n\n* Breast or prostate cancer\n* Palpable prostate nodule or induration or prostate specific antigen (PSA) ≥ 4 ng/ml\n* PSA ≥ 3 ng/ml in men at high risk of prostate cancer, such as African Americans or men with first-degree relatives with prostate cancer\n* Hematocrit ≥ 50%\n* Decompensated heart failure as determined by a physician'}, 'identificationModule': {'nctId': 'NCT02203656', 'acronym': 'PACE', 'briefTitle': 'Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Feasibility Study of Post-hospitalization Interventions to Improve Physical Function', 'orgStudyIdInfo': {'id': '13-038'}, 'secondaryIdInfos': [{'id': '1229', 'type': 'OTHER_GRANT', 'domain': 'Dairy Research Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Supplement', 'description': 'Daily placebo supplement for 30 days after discharge.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Nutritional Supplement', 'description': 'Daily nutritional supplement for 30 days after discharge.', 'interventionNames': ['Dietary Supplement: Nutritional Supplement']}, {'type': 'EXPERIMENTAL', 'label': 'In-home exercise + placebo', 'description': 'in-home exercise 3 times a week and daily placebo supplement for 30 days after discharge.', 'interventionNames': ['Drug: Placebo', 'Behavioral: In-home exercise']}, {'type': 'EXPERIMENTAL', 'label': 'In-home exercise + nutrition', 'description': 'in-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge.', 'interventionNames': ['Dietary Supplement: Nutritional Supplement', 'Behavioral: In-home exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Testosterone', 'description': 'Single testosterone injection within 24 hours of hospital discharge.', 'interventionNames': ['Drug: Testosterone']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Control'], 'description': 'placebo supplement', 'armGroupLabels': ['In-home exercise + placebo', 'Placebo Supplement']}, {'name': 'Nutritional Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'protein supplement', 'armGroupLabels': ['In-home exercise + nutrition', 'Nutritional Supplement']}, {'name': 'In-home exercise', 'type': 'BEHAVIORAL', 'description': 'In-home exercise program', 'armGroupLabels': ['In-home exercise + nutrition', 'In-home exercise + placebo']}, {'name': 'Testosterone', 'type': 'DRUG', 'otherNames': ['Testosterone enanthate'], 'description': 'Testosterone injection', 'armGroupLabels': ['Testosterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77550', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'UTMB Acute Care for Elders Unit', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Jennie Sealy Hospital', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Elena Volpi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTMB'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No. This is a small Phase 1 pre-pilot study. Risk of loss of confidentiality'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dairy Research Institute', 'class': 'OTHER'}, {'name': 'National Dairy Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}