Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-02-19 @ 5:28 AM
Study NCT ID:
NCT03609203
Status:
COMPLETED
Last Update Posted:
2022-04-04
First Post:
2018-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Self-Efficacy, Resolving Inflammaging Allo HSCT Survivors in Personal Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-31', 'studyFirstSubmitDate': '2018-07-24', 'studyFirstSubmitQcDate': '2018-07-24', 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported outcomes of self-efficacy', 'timeFrame': 'Week 10', 'description': 'To quantify the changes in self-reported outcomes of self-efficacy after ten weeks of strength training in patients compared to controls.'}], 'secondaryOutcomes': [{'measure': 'Biomarkers of inflammaging in the blood', 'timeFrame': 'Week 10', 'description': 'To evaluate changes in biomarkers of inflammaging in the blood of HCT recipients before and after the intervention compared to controls.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allogeneic HCT Survivors']}, 'descriptionModule': {'briefSummary': 'This protocol is a pilot study of a personalized and supervised 10-week strength training program to improve self-efficacy and resolve biomarkers of inflammaging in a cohort of allogeneic hematopoietic transplant (HCT) long-term survivors versus healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A maximum of four pairs of patient/workout partners (8 subjects) should be actively participating in the 10-week group intervention on study at a time. Participants may sign consent at anytime but then begin group participation when spots become available.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy Volunteers: must be the friends or relatives of the cancer patients enrolled in this study.\n\nInclusion Criteria:\n\n* HCT recipients\n\n * Age ≥ 18 years\n * Greater than 6 months after completing systemic multiagent chemotherapy (greater than 12 months for HCT participants) at the time of enrollment. Maintenance chemotherapy is allowed\n * In remission from cancer Off immunosuppression, or on a stable immunosuppression regimen with prednisone doses ≤ 20 mg daily, with no changes planned to the immunosuppression regimen during the study period\n * Karnofsky performance status ≥ 50% (Appendix III)\n * Platelet count ≥ 50,000 without transfusions\n * Absolute neutrophil count ≥ 1\n * Willing to complete weekly strength training sessions for 10 consecutive weeks and complete all pre- and post-testing (self-efficacy survey and research blood draw)\n * Currently reside within the Minneapolis-St. Paul metro area\n * Has an adult (age ≥ 18) friend or relative who is willing to serve as an exercise partner and healthy control for the study\n * If known diabetic: Stable doses of medications to treat diabetes within 4 weeks prior to enrollment\n * Willing and able to sign voluntary written consent\n* Healthy Controls\n\n * Age ≥ 18 years\n * Karnofsky performance status ≥ 50%\n * Willing to complete weekly strength training sessions for 10 consecutive weeks and complete all pre- and post-testing (self-efficacy survey and research blood draw)\n * Currently reside within the Minneapolis-St. Paul metro area\n * If known diabetic: Stable doses of medications to treat diabetes within 4 weeks prior to enrollment\n * Willing and able to sign voluntary written consent\n\nExclusion Criteria for both Cancer Survivors and Controls\n\n* Presence of an external central venous catheter (Hickman, PICC, etc); Port-a-cath devices that are completely internal are allowed\n* Use of ≥ 20+ mg prednisone daily\n* Current or planned use of investigational drugs during the study period\n* Myocardial infarction or stroke within 6 months\n* Heart failure graded Class IV on New York Heart Association (NYHA) scale (https://manual.jointcommission.org/releases/TJC2018A/DataElem0439.html)\n* Any medical condition that the consenting medical provider deems would make the participant unsafe to perform a 10-week strength training program\n* Are currently pregnant'}, 'identificationModule': {'nctId': 'NCT03609203', 'briefTitle': 'Improving Self-Efficacy, Resolving Inflammaging Allo HSCT Survivors in Personal Training', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'Improving Self-Efficacy and Resolving Inflammaging in Allogeneic Hematopoietic Cell Transplant Survivors Through Personalized Strength Programming: A Pilot Study', 'orgStudyIdInfo': {'id': '2018NTLS073'}, 'secondaryIdInfos': [{'id': 'MT2018-09R', 'type': 'OTHER', 'domain': 'University of Minnesota Masonic Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'interventionNames': ['Other: 10 Weeks of Strength Trailing', 'Other: Group Nutrition Discussion: week 1, week 5 and week 10']}, {'label': 'Controls', 'interventionNames': ['Other: 10 Weeks of Strength Trailing', 'Other: Group Nutrition Discussion: week 1, week 5 and week 10']}], 'interventions': [{'name': '10 Weeks of Strength Trailing', 'type': 'OTHER', 'description': 'Week 1 (pre training session): self efficacy survey; 5-point frailty assessment\\*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample\n\nWeek 5: self efficacy survey; Functional status and body composition\n\nWeek 10: self efficacy survey; 5-point frailty assessment\\*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples', 'armGroupLabels': ['Controls', 'Patients']}, {'name': 'Group Nutrition Discussion: week 1, week 5 and week 10', 'type': 'OTHER', 'description': 'Week 1 (pre training session): self efficacy survey; 5-point frailty assessment\\*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample\n\nWeek 5: self efficacy survey; Functional status and body composition\n\nWeek 10: self efficacy survey; 5-point frailty assessment\\*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples', 'armGroupLabels': ['Controls', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center, University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Shernan G Holtan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Hematology, Oncology and Transplantation, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}