Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-03-11 @ 9:03 PM
Study NCT ID:
NCT06518369
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2024-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Prehabilitation Program For Geriatric Patients in a Rural Healthcare Setting
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2024-07-23', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative hospital length of stay', 'timeFrame': 'From date of hospitalization until date of hospital discharge, up to 30 days', 'description': 'Number of days in hospital from date of surgery to date of discharge'}, {'measure': 'Discharge disposition', 'timeFrame': 'From date of hospitalization until date of hospital discharge, up to 30 days', 'description': 'Binary measure of either home or rehabilitation facility'}], 'secondaryOutcomes': [{'measure': 'Adverse outcomes after surgery', 'timeFrame': '30 days after surgery', 'description': 'Assess adverse outcomes postoperatively'}, {'measure': 'Hospital readmission rates', 'timeFrame': '30 days after surgery', 'description': 'Number of times patients are readmitted to the hospital within 30 day of surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frailty'], 'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'The study will include patients who require elective major abdominal surgery for cancerous or non-cancerous conditions. The goal of the research is to assess the benefit of a prehabilitation program before surgery that includes nutrition, exercise, smoking cessation, and optimization of chronic disease. A group of 10 patients will take part in a prehabilitation program. These patients will be compared to 20 patients who received standard of care.', 'detailedDescription': 'The study will include patients who require elective major abdominal surgery. The study will compare patients who received standard of care to patients who received a prehabilitation program before surgery.\n\nThe prehabilitation program will take place for 4-6 weeks before your surgery and will include:\n\n* Review of frailty risk analysis calculator score obtained in the frailty study (#2212-74)\n* Review of lab results including complete blood count, creatinine, albumin, and prealbumin\n* Review of chronic conditions\n* An office visit or telehealth visit to review instructions on nutrition, exercise, smoking cessation, and optimization of chronic disease.\n* Drinking Surgery Immunonutrition shake twice daily for 5 days before surgery.\n* Educational information and video instruction\n* Weekly phone calls to motivate, ensure adherence, and assess progress.\n* Measurements of hand grip strength and body weight'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects over age 60 who require elective major abdominal surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects over age 60 who require elective major abdominal surgery\n\nExclusion Criteria:\n\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT06518369', 'briefTitle': 'Preoperative Prehabilitation Program For Geriatric Patients in a Rural Healthcare Setting', 'organization': {'class': 'OTHER', 'fullName': 'The Guthrie Clinic'}, 'officialTitle': 'Analysis of a Preoperative Prehabilitation Program Among Rural Geriatric Patients Compared to Standard of Care', 'orgStudyIdInfo': {'id': '2401-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-intervention or standard of care group', 'description': '20 Patients who received standard of care'}, {'label': 'Prehabilitation Group', 'description': '10 patients who take part in a prehabilitation program for 4-6 weeks before surgery', 'interventionNames': ['Other: Prehabilitation']}], 'interventions': [{'name': 'Prehabilitation', 'type': 'OTHER', 'description': 'Prehabilitation program for 4-6 weeks before surgery will include:\n\n* Review of the frailty risk analysis calculator score obtained in the frailty study (#2212-74)\n* Review of lab results including complete blood count, creatinine, albumin, and prealbumin\n* Review of chronic conditions.\n* An office visit or telehealth visit to review instructions on instructions on nutrition, exercise, smoking cessation, and optimization of chronic disease.\n* Drinking surgery immunonutrition drinks twice daily for 5 days before surgery.\n* Educational information and video instruction\n* Weekly phone calls to motivate, ensure adherence, and assess progress.\n* Measurements of hand grip strength and body weight', 'armGroupLabels': ['Prehabilitation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18840', 'city': 'Sayre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Robert Packer Hospital', 'geoPoint': {'lat': 41.97896, 'lon': -76.5155}}], 'overallOfficials': [{'name': 'Nancy Georgetson, AGNP-C', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert Packer Hospital Sayre PA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Guthrie Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}